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National Collaborating Centre for Mental Health (UK). Antenatal and Postnatal Mental Health: Clinical Management and Service Guidance: Updated edition. Leicester (UK): British Psychological Society; 2014 Dec. (NICE Clinical Guidelines, No. 192.)
April 2018: Footnotes and cautions have been added and amended by NICE to link to the MHRA's latest advice and resources on sodium valproate. Sodium valproate must not be used in pregnancy, and only used in girls and women when there is no alternative and a pregnancy prevention plan is in place. This is because of the risk of malformations and developmental abnormalities in the baby.
Antenatal and Postnatal Mental Health: Clinical Management and Service Guidance: Updated edition.
Show details7.1. INTRODUCTION
Pregnancy, childbirth and the first postnatal year is a unique period of change for women. This period of transition may interact with women's psychological, social and biological vulnerabilities, culminating in psychological distress and mental ill health. The effects of poor mental health during the perinatal period can be especially difficult for women during a time when they face additional expectations and infant care demands. Further, emotional distress and problems during pregnancy, childbirth and the postnatal period warrant particular attention because of the longitudinal impact these difficulties have on the developing fetus and newborn baby, effects which are often mediated through the woman's disrupted relationship with her infant.
Psychological difficulties in pregnancy and the postnatal period range from minor transient disturbance with rapid unaided adjustment through common mental health problems to severe psychiatric disturbance. Pregnancy, childbirth and the demands and transitions associated with having a new child may precipitate or worsen psychological problems or lead a woman to seek help for previous and/or long-standing difficulties at this time.
Given that the nature of most mental health problems in pregnancy is little different from that of mental health problems of non-pregnant women in both their presentation and course, it is reasonable to assume, in the absence of evidence to the contrary, that treatment developed for non-pregnant women is likely to be effective. However, a number of factors specific to pregnancy and the postnatal period may alter the efficacy of psychological treatments in pregnancy and the following postnatal year. These include access, both in terms of the availability of the treatments and the women's capacity (relative to increased physical demands and childcare demands), the relative cost effectiveness of the treatments and, in particular, the need to consider the relative benefits of drug and psychological treatments in light of the increased risk of harm to the fetus associated with pharmacological treatment in pregnancy or during breastfeeding.
This chapter is concerned with reviewing psychological and psychosocial interventions for the prevention or treatment of mental health problems in the pregnancy and the postnatal period, together with health economics evidence where appropriate. It also considers broader psychosocial interventions, such as protocols for mothers whose babies are stillborn.
7.2. FACTORS TO CONSIDER IN THE EVALUATION OF PSYCHOLOGICAL AND PSYCHOSOCIAL TREATMENT
7.2.1. Prevention versus treatment distinction
There is a great deal of inconsistency across studies in how disorders in pregnancy or the postnatal period are characterized, for instance, psychiatric diagnosis compared with scoring above a threshold on a scale (clinician-rated or self-report). This variability is also reflected in how researchers define their trials as preventative or as treatment. This lack of consistency makes it difficult to assess like for like within meta-analyses. Therefore, for the purposes of clarity and transparency it was decided that this review would use inclusion criteria and/or baseline mean symptom scores to make the distinction between prevention and treatment studies. Where participants in a trial had a psychiatric diagnosis the study was included in the treatment review. However, where the disordered group were defined based on symptomatology, consistent criteria (Table 30) were used to categorise subthreshold symptoms and symptoms of the disorder into the treatment review and below threshold symptoms into the prevention review. It is important to note that these cut-offs are distinct from symptomatology as an outcome, in which case we are limited by the thresholds selected by the trials and these are frequently higher (with moderate rather than mild cut-offs).
Table 30
Criteria for categorising prevention and treatment studies.
7.2.2. Review strategy and sub-analyses
The review strategy was to evaluate the clinical effectiveness of the interventions using meta-analysis by intervention. Following this, sub-analysis was conducted (dependent on available data), based on: risk factor for prevention studies (risk factors identified) or baseline diagnostic status for treatment studies (clinical diagnosis [usually assessed using structured psychiatric interview]; symptoms [above a pre-specified threshold on a rating scale]; subthreshold symptoms [just below a pre-specified threshold on a rating scale]); treatment timing (antenatal and/or postnatal); mode of delivery (for instance, face-to-face, internet, telephone and so on), format (individual and/or group), and intensity (low [<8 sessions contact with a healthcare professional]; moderate [8-15 sessions of contact]; high [≥16 sessions of contact]).
7.3. DEFINITIONS OF PSYCHOLOGICAL AND PSYCHOSOCIAL INTERVENTIONS
This chapter considers non-pharmacological treatments, including psychological therapies such as CBT and IPT and psychosocial interventions such as social support. The definitions of the main psychological and psychosocial treatments covered in this guideline are listed below.
7.3.1. Cognitive behavioural therapy
CBT for depression was developed by Aaron Beck during the 1960s. One of the assumptions underlying this form of therapy is that psychological distress is strongly influenced by patterns of thinking, beliefs and behaviour. Depressed patients have patterns of thinking and reasoning that focus on a negative view of the world (including themselves and other people) and what they can expect from it. Psychological distress may be alleviated by altering these thought patterns and behaviours without the need to understand how earlier life events or circumstances may have contributed to how those patterns arose. A key aspect of the therapy is an educative approach, where the patient learns to recognise their negative thinking patterns and how to re-evaluate them. The new approach needs to be practised outside of the sessions in the form of homework.
CBT is a discrete, time-limited, structured psychological treatment. The patient and therapist work collaboratively to identify the types of thoughts, beliefs and interpretations and their effects on current symptoms, feeling states and problem areas. The patient then develops the skills to identify, monitor and counteract problematic thoughts, beliefs and interpretations related to the target symptoms. The patient also learns a repertoire of coping skills appropriate to targeting thoughts, beliefs or problem areas. CBT is usually delivered as an individually focused therapy but has also been developed as a group treatment. Common antenatal and postnatal modifications include delivery in the home of the mother or mother-to-be.
7.3.2. Co-parenting intervention
This intervention is based on the assumption that the postnatal period may be a time of increased stress not just in terms of the transition to motherhood but also in terms of marital adjustment as women attempt to handle both maternal and marital roles. The intervention involves partners in therapy sessions, and positive interaction and communication between the couple is encouraged by discussing strategies for child care and housework.
7.3.3. Directive counselling
This intervention incorporated elements of supportive listening and history taking in common with listening visits (non-directive counselling) but also included more directive techniques of problem clarification, goal formation, problem solving and partner sessions. This intervention can be delivered individually or in a group format.
7.3.4. Home visits
A structured series of prenatal and infancy visits by either lay home visitors or health professionals to provide emotional and practical support (such as how to care for the infant and/or how to access appropriate health and social services).
Home visitors can assist parents to improve: the outcomes of pregnancy, by helping women improve their prenatal health; children's subsequent health and development by helping parents provide competent infant and toddler care; maternal physical and mental health by facilitating access to appropriate community services; mother–infant interactions by helping mothers to be sensitive and respond to their child's behavioural cues; parents' economic self-sufficiency by helping them complete their education, find work, and plan future pregnancies.
7.3.5. Infant sleep interventions
Infant sleep interventions such as controlled crying and camping out, are based on behavioural principles. Controlled crying describes the process of sleep training whereby parents respond to their infant's cry at increasing time intervals, and is based on the principle that infants need to be taught to fall asleep independently in order to self-settle after night waking. Camping out is based on the same underlying principles as controlled crying but involves a parent sitting with their infant until they fall asleep and gradually removing their presence over a few weeks. These interventions involve the provision of information about normal sleep cycles and the development and management of sleep problems, and discussion and development of individually tailored sleep-management plans.
7.3.6. Interpersonal psychotherapy
IPT was developed by Klerman and colleagues (1984) initially for depression, although its use has been extended to other areas (Weissman et al., 2000). It may be defined as a discrete, time-limited, structured psychological treatment derived from an interpersonal model of affective disorders that focuses on interpersonal issues. The patient and therapist work collaboratively to identify effects of key problem areas related to interpersonal conflicts, role transitions, grief and loss, and social skills, and their effect on current symptoms, feeling states and/or problems. The treatment seeks to reduce symptoms by learning to cope with or resolve these interpersonal issues.
IPT focuses on current relationships and interpersonal processes and on the difficulties that arise in the daily experience of maintaining relationships and resolving difficulties. The main tasks are to help patients to link their mood with their interpersonal contacts, recognising that, by appropriately addressing interpersonal problems, they may improve both relationship and mood. There is usually an agreed focus for treatment, such as interpersonal role transitions. Therapy sessions concentrate on facilitating understanding of recent events in interpersonal terms and exploring alternative ways of handling interpersonal situations. IPT is usually delivered as an individually focused therapy but has also been developed as a group treatment. Common antenatal and postnatal modifications include delivery in the home of the mother or mother-to-be.
7.3.7. Listening visits (non-directive counselling)
Counselling was developed by Rogers (1957) who believed that people had the means for self-healing, problem resolution and growth if the right conditions could be created. These include the provision of positive regard, genuineness and empathy. Rogers' original model was developed into structured counselling approaches by both Truax and Carkhuff (1967) and Egan (1990). Voluntary sector counselling training tends to draw on these models. Counsellors are trained to listen and reflect patient feelings and meaning (Rogers, 1957). Many other therapies use these basic ingredients of client-centred counselling, but there are differences in how they are used. Holden and colleagues (1989) developed the concept of ‘listening visits’ based on these Rogerian, non-directive counselling skills and this has been taken up by a number of healthcare professionals working in the postnatal area, in particular health visitors. The healthcare professional is trained to help clients to gain better understanding of their circumstances and themselves. The therapist adopts an empathic and non-judgemental approach, listening rather than directing but offering non-verbal encouragement, reflecting back to assist the person in making decisions. This approach is usually offered by briefly trained healthcare professionals rather than mental health professionals and often takes place in the client's home.
7.3.8. Mindfulness training
Mindfulness-based cognitive therapy was developed with a specific focus on preventing relapse/recurrence of depression (Segal et al., 2002). It is derived from mindfulness-based stress reduction and CBT for acute depression. Mindfulness-based cognitive therapy is intended to enable people to learn to become more aware of the bodily sensations, thoughts and feelings associated with depressive relapse, and to relate constructively to these experiences. It is based on theoretical and empirical work demonstrating that depressive relapse is associated with the reinstatement of automatic modes of thinking, feeling and behaving that are counterproductive in contributing to and maintaining depressive relapse and recurrence (for example, self-critical thinking and avoidance) (Lau et al., 2004). Participants learn to recognise these ‘automatic pilot’ modes, step out of them and respond in healthier ways by intentionally moving into a mode in which they ‘de-centre’ from negative thoughts and feelings (for example, by learning that ‘thoughts are not facts’), accept difficulties using a stance of self-compassion and use bodily awareness to ground and transform experience. Common postnatal-specific modifications include the presence of babies in the room during sessions and replacing a longer single meditation per session with a few shorter meditations.
7.3.9. Mother-infant relationship interventions
Mother-infant relationship interventions are psychological interventions where the goal is to improve the relationship between the mother and infant. These interventions are based on a psychological theory about the nature of attachment between the mother and infant. These interventions typically involve observations of mother–infant interactions, feedback (often video-based), modelling and cognitive restructuring. The primary aim is to enhance maternal sensitivity to child behavioural cues and awareness of the child's developing skills and needs.
7.3.10. Music therapy during delivery
This intervention involves listening to self-selected music during spontaneous vaginal delivery. The intervention is based on the principle that music may have anxiolytic and analgesic properties and improved satisfaction with the childbirth experience is also hypothesized to impact upon depression in the postnatal period.
7.3.11. Non-mental health-focused education and support
A structured educational treatment (often offered in groups) which may focus on preparation for childbirth (antenatal/in pregnancy) or practical aspects of childcare (postnatal). Such interventions offer an integrated approach to pregnancy, delivery and the mental and physical health and well-being of the woman and the infant and may include a focus on the social and personal adjustment to the role of a parent following the birth of a child (Gagnon, 2000).
7.3.12. Peer-mediated support and support groups
Peer-mediated support is a system of giving and receiving help founded on key principles of respect, shared responsibility, and mutual agreement of what is helpful and is primarily in one direction with a clearly defined peer supporter and recipient of support. Peer volunteers who are mothers themselves and also have a history of antenatal or postnatal mental health problems are recruited and trained to deliver interventions. These interventions can include befriending and mentoring.
Support groups also provide an opportunity for peer support but are usually facilitated by a healthcare professional and discussions are usually structured around a series of pre-defined topic areas (for instance, transition to motherhood, postnatal stress management, co-parenting challenges). However, the primary goal of these interventions is to enable mutual support by bringing women into contact with other women who are having similar experiences and providing opportunities for sharing problems and solutions.
7.3.13. Post-miscarriage interventions
Post-miscarriage interventions may take the form of self-help, facilitated self-help or counselling, all with the common aim of providing meaning to the miscarriage experience. Intervention content typically includes discussion of: coming to terms with the loss; sharing the loss; resuming life as a non-pregnant woman; trying again.
7.3.14. Post-traumatic birth discussion and/or counselling
The purpose of the intervention is to: explain to women what happened in delivery; give the woman an option to discuss labour, birth, and post-delivery experiences; and to answer any questions she has. The content of the discussion is determined by each woman's experiences and concerns and the intervention is delivered by midwives and obstetricians who are experienced in talking with women about birth, able to listen with empathy to women's accounts, and aware of the common concerns and issues arising. It is important to note that this intervention does not include post-trauma debriefing (based on adapted Critical Incident Stress Debriefing [Mitchell, 1983]).
7.3.15. Pre-delivery discussion and psychoeducation
This intervention is aimed at addressing tokophobia (fear of childbirth) and typically involves the provision of information about childbirth and an opportunity to discuss previous obstetric experiences, feelings and misconceptions. This psychoeducative discussion can be delivered individually or in a group format. Such discussions may be psychologically-informed, for instance, incorporating CBT principles of focusing on the target problem and reformulation of this problem through self-reflection and cognitive restructuring, and may also include guided relaxation exercises.
7.3.16. Protocols for women following stillbirth
Protocols for women following stillbirth may include seeing and/or holding the stillborn infant, keeping photographs or mementoes and having a funeral.
7.3.17. Psychologically (CBT or IPT)-informed psychoeducation
Psychoeducation is a structured educational treatment (often offered in groups), which may focus on preparation for childbirth (antenatal) or practical aspects of childcare (postnatal) but also includes a specific mental health component with information about common mental health disorders in the antenatal and/or postnatal period. These interventions are often informed by psychological principles and as such techniques from CBT and/or IPT are used such as cognitive restructuring, pleasant event scheduling, role play, guided relaxation, and homework exercises. The research on psychologically-informed psychoeducation interventions has most commonly involved women with subthreshold symptoms of depression, but has also been used for women with subthreshold symptoms of OCD.
7.3.18. Psychosomatic interventions
These interventions involve a comprehensive psychosomatic assessment, supportive therapy, psychoeducation and relaxation techniques and are guided by the principle that stress associated with pregnancy may be linked to the long-term course of anxiety, depression and physical complaints.
7.3.19. Self-help and facilitated self-help
Self-help interventions are psychological interventions typically based on cognitive behavioural principles that seek to equip people with strategies and techniques to begin to overcome and manage their psychological difficulties. Self-help usually provides information in the form of books or other written materials that include psychoeducation about the problem and describe techniques to overcome it. Although computerised interventions have the potential to be interactive and individualised, those that have been tested in clinical trials are, for the most part, relatively fixed programmes. In ‘pure’ self-help, only the written materials are used, in facilitated self-help, a therapist or alternatively a computer-based system (stand alone or web based) assists the service user in using the materials.
7.4. PSYCHOLOGICAL AND PSYCHOSOCIAL INTERVENTIONS FOR THE PREVENTION OF MENTAL HEALTH PROBLEMS
7.4.1. Introduction (prevention)
Prevention of disease is the ultimate quest for all working in healthcare but is rarely achievable, particularly in complex human conditions such as mental health problems. Antenatal and postnatal mental health care offers tantalizing theoretical opportunities for prevention, not just in this generation but the next and beyond. In common with most preventative health care, primary prevention in the field of antenatal and postnatal mental health presents the greatest challenge and is likely to rely on interventions outside the traditional remit of health services. For example, a recent study found that the strongest predictor of antenatal depression was the woman's own history of childhood maltreatment (Plant et al., 2013).
It is in secondary prevention (limiting the development or recurrence of mental health problems) and tertiary prevention (reducing the effects of mental health problems on mother and child) that antenatal and postnatal mental health care offers unique and realistic opportunities as we have advanced notice of periods of known high risk, in identifiable high risk groups, amongst a population that has universal contact with health professionals. Furthermore, current evidence suggests that the potential target outcomes are not restricted to mental disorders in the mother, but could extend to physical health, exposure to maltreatment and intellectual and social functioning in the child. However, evidence on the effectiveness of preventative interventions is only just beginning to emerge and is at present meagre, although some important conclusions are possible. These have led to both positive and negative recommendations of relevance to service planners, clinicians and women themselves. Nevertheless, it is striking that important clinical dilemmas remain uninformed by robust trial evidence.
7.4.2. Clinical review protocol (prevention)
The review protocol summary, including the review question(s) and the eligibility criteria used for this section of the guideline, can be found in Table 31. A complete list of review questions can be found in Appendix 8; further information about the search strategy can be found in Appendix 10; the full review protocols can be found in Appendix 9.
Table 31
Clinical review protocol summary for the review of psychological and psychosocial interventions for the prevention of mental health problems.
The review strategy was to evaluate the clinical effectiveness of the interventions using meta-analysis. However, in the absence of adequate data, the available evidence was synthesised using narrative methods. An analysis of all interventions was conducted and graded. Following this sub-analysis was conducted (dependent on available data), based on risk factor, treatment timing, format (individual and/or group), and intensity. Where possible both an available case analysis and an intention-to-treat (ITT) analysis (worst case scenario [WCS]) were used.
7.4.3. Studies considered11 (prevention: identified risk factors)
Twenty-two RCTs reported across 25 papers met the eligibility criteria for this review: ARACENA2009 (Aracena et al., 2009), BARLOW2007 (Barlow et al., 2007), BARNET2007 (Barnet et al., 2007), BRUGHA2000 (Brugha et al., 2000), COOPER2009 (Cooper et al., 2009), EASTERBROOKS2013 (Easterbrooks et al., 2013), GORMAN1997/DENNIS2013 (Gorman, 1997; paper unavailable, so data extracted from Dennis & Dowswell, 2013), HARRIS2006/DENNIS2013 (Harris et al., 2006; paper unavailable, so data extracted from Dennis & Dowswell, 2013), HOWELL2012 (Howell et al., 2012), KERSTING2013 (Kersting et al., 2013), KIEFFER2013 (Kieffer et al., 2013), MEIJSSEN2010A/2010B/2011 (one study reported across three papers: Meijssen et al., 2010a; Meijssen et al., 2010b; Meijssen et al., 2011), MELNYK2006 (Melnyk et al., 2006), MEYER1994 (Meyer et al., 1994), NEWNHAM2009 (Newnham et al., 2009), PHIPPS2013 (Phipps et al., 2013), RAVN2012 (Ravn et al., 2012), SEN2006/DENNIS2013 (Sen, 2006; paper unavailable, so data extracted from Dennis & Dowswell, 2013), SMALL2000/2006 (one study reported across two papers: Small et al., 2000; Small et al., 2006), SPITTLE2010/2009/SPENCERSMITH2012 (one study reported across three papers: Spittle et al., 2009; Spittle et al., 2010; Spencer-Smith et al., 2012), STAMP1995 (Stamp et al., 1995), WEBSTER2003 (Webster et al., 2003). All of these studies were published in peer-reviewed journals between 1994 and 2013. In addition, 33 studies were excluded from the review. The most common reasons for exclusion were that data could not be extracted (for instance, because means and standard deviations were not reported), or there were no mental health outcomes reported, or the studies were not RCTs. Further information about both included and excluded studies can be found in Appendix 18.
For the review of protocols for women following stillbirth, four cohort studies reported across six papers met the eligibility criteria for this review: CACCIATORE2008 (Cacciatore et al., 2008), GRAVENSTEEN2013 (Gravensteen et al., 2013), HUGHES2002/TURTON2009 (Hughes et al., 2002; Turton et al., 2009), RADESTAD2009A/SURKAN2008 (Rådestad et al., 2009a; Surkan et al., 2008). All of these studies were published in peer-reviewed journals between 2002 and 2013. In addition, two studies were excluded (CRAWLEY2013 [Crawley et al., 2013], RADESTAD2009B [Rådestad et al., 2009b]) as data could not be extracted as there was not a sufficient comparison group (>90% saw and held the stillborn infant). Further information about both included and excluded studies can be found in Appendix 18.
Of the 22 included RCTs, there was one study (N=228) involving a comparison of post-miscarriage self-help and treatment as usual (Table 32). The term post-miscarriage is used as a proxy for loss of baby during pregnancy due to miscarriage, termination due to fetal abnormality, or stillbirth.
Table 32
Study information table for trials included in the prevention (risk factors identified) meta-analysis of self-help versus any alternative management strategy.
There was one study (N=117) that compared social support (peer-mediated support) with treatment as usual (Table 33). This study did not clarify risk factors but defined the sample as ‘at risk’.
Table 33
Study information table for trials included in the prevention (risk factors identified) meta-analysis of social support versus any alternative management strategy.
There were three studies (N=360) that involved a comparison between psychologically (CBT/IPT)-informed psychoeducation and treatment as usual or enhanced treatment as usual for women with psychosocial risk factors, for teenage mothers, or for women classified as ‘at risk’ but where risk factors were not defined. Two studies (N=1,140) compared a psychoeducational booklet and treatment as usual or enhanced treatment as usual for women with psychosocial risk factors. Four studies (N=844) compared non-mental health-focused education and support and treatment as usual or enhanced treatment as usual for women with a range of risk factors including psychosocial risk factors, preterm delivery and low birthweight baby, and multiple (twin) pregnancy. Five studies (N=1,146) involved a comparison of home visits and treatment as usual predominantly for women with psychosocial risk factors, but also including teenage mothers and one study which examined women at risk of mental health problems due to preterm delivery. One study (N=1,041) compared post-delivery discussion and enhanced treatment as usual (Table 34) for women who had had an operative delivery.
Table 34
Study information table for trials included in the prevention (risk factors identified) meta-analysis of education or support versus any alternative management strategy.
Four studies (N=799) compared mother–infant relationship interventions and treatment as usual (Table 35) for women with psychosocial risk factors or with premature or low birthweight babies.
Table 35
Study information table for trials included in the prevention (risk factors identified) meta-analysis of mother–infant relationship interventions versus any alternative management strategy.
There was one study (N=34) that involved a comparison between case management and individualized treatment and treatment as usual (Table 36) for women who had preterm delivery and low birthweight babies.
Table 36
Study information table for trials included in the prevention (risk factors identified) meta-analysis of other psychosocial interventions versus any alternative management strategy.
Four studies (N=2,772) compared mental health outcomes in women who saw and/or held their stillborn infants compared with those who did not (Table 37).
Table 37
Study information table for trials included in the prevention (risk factors identified) meta-analysis of protocols following stillbirth.
7.4.4. Clinical evidence for preventative effects on depression outcomes for women with identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Depression: post-miscarriage self-help versus treatment as usual
There was single study (N=228) evidence for a moderate preventative benefit of post-miscarriage self-help on depression mean symptoms (p <0.00001). However, the confidence in this effect estimate is low due to risk of bias (statistically significant group differences at baseline) and imprecision (optimal information size [N=400] is not met). The outcome measure is also a subscale of a global severity measure (Brief Symptom Inventory [BSI]: Depression) rather than a depression-specific scale (Table 38).
Table 38
Summary of findings table for effects of post-miscarriage self-help compared with treatment as usual on preventing depression outcomes in women with identified risk factors.
Depression: social support versus treatment as usual
There was very low quality, single study (N=65) evidence for a large preventative benefit of social support on depression diagnosis (p=0.01) in women at risk of developing postnatal depression, when using an available case analysis approach. However, ITT analysis of this outcome measure revealed no evidence for statistically or clinically significant effects of social support on depression diagnosis (p=0.22). Moreover, there are risk of bias concerns with this study due to non-blind outcome assessment (Table 39).
Table 39
Summary of findings table for effects of social support compared with treatment as usual on preventing depression outcomes in women with identified risk factors.
Depression: Psychologically (CBT/IPT)-informed psychoeducation versus treatment as usual or enhanced treatment as usual
The evidence for psychologically (CBT/IPT)-informed psychoeducation as a preventative intervention for women at-risk of developing postnatal depression was inconsistent (Table 40). There was evidence from three studies (N=320-360) for moderate to large effects of psychoeducation on preventing depression diagnosis (using either ITT [p=0.08] or available case [p=0.05] data analysis). However, the confidence in this effect estimate is low due to very serious imprecision (small event rate and the 95% CI included both no effect and appreciable benefit). This effect was also not maintained at intermediate (17-24 weeks post-intervention) follow-up (p=0.51-0.53). In addition, no clinically or statistically significant preventative effects were observed on depression symptomatology at endpoint (p=0.41-0.66) or intermediate follow-up (p=0.63-1), or depression mean symptoms at endpoint (p=0.86) or intermediate follow-up (p=0.96).
Table 40
Summary of findings table for effects of psychologically (CBT/IPT)-informed psychoeducation compared with treatment as usual or enhanced treatment as usual on preventing depression outcomes in women with identified risk factors.
Depression: Psychoeducational booklet versus treatment as usual or enhanced treatment as usual
There was low to very low quality evidence from up to two studies (N=1,140) for moderate effects of a psychoeducational booklet on preventing depression symptomatology (p=0.10-0.11) in women with psychosocial risk factors when an available case analysis approach was used (Table 41). However, moderate to low quality evidence from ITT analyses provided no evidence for psychoeducation as an intervention to prevent depression symptomatology (p=0.12-0.46).
Table 41
Summary of findings table for effects of psychoeducational booklet compared with treatment as usual or enhanced treatment as usual on preventing depression outcomes in women with identified risk factors.
Depression: non-mental health-focused education and support versus treatment as usual or enhanced treatment as usual
Low quality evidence from up to two studies (N=306) suggests that non-mental health-focused education and support may be more effective than treatment as usual or enhanced treatment as usual at preventing depression symptomatology for women with multiple births or at risk of developing postnatal depression (no further details reported) with moderate effects observed at endpoint (p=0.07-0.15) and moderate to large effects observed at short-term (9-16 weeks post-intervention) follow-up (p=0.09). However, effects were not maintained at intermediate (p=0.77-0.81) or long-term (p=0.40-0.72) follow-ups, and there was no evidence for statistically or clinically significant preventative benefits for depression mean symptoms at any time point (p=0.09-0.64) (Table 42).
Table 42
Summary of findings table for effects of non-mental health-focused education and support compared with treatment as usual or enhanced treatment as usual on preventing depression outcomes in women with identified risk factors.
Depression: home visits versus treatment as usual
Using an available case data analysis approach there is single study (N=77) evidence suggesting that home visits may be more effective than treatment as usual at preventing depression symptomatology at very long (>104 weeks post-intervention) follow-up (p=0.28). However, confidence in this effect estimate is very low due to risk of bias concerns (statistically significant group differences in depression symptomatology at baseline) and very serious imprecision (optimal information size [that is, 300 events] is not met and 95% CI includes no effect, appreciable benefit and appreciable harm). Moreover, the ITT analysis of this outcome measure is not statistically or clinically significant (p=0.60) and there is no evidence (from up to three studies; N=684) for statistically or clinically significant effects on depression symptomatology at endpoint or first measurement (p=0.42-0.87) or depression mean symptoms at very long follow-up (p=0.11), or for clinically significant effects on mean depression symptoms at endpoint (p=0.04) (Table 43).
Table 43
Summary of findings table for effects of home visits compared with treatment as usual on preventing depression outcomes in women with identified risk factors.
Depression: post-delivery discussion versus enhanced treatment as usual
There was no evidence (Table 44) that a post-delivery discussion was more effective than enhanced treatment as usual (non-mental health-focused information [booklet]) at preventing depression in women following an operative delivery (p=0.23-0.87).
Table 44
Summary of findings table for effects of post-delivery discussion compared with enhanced treatment as usual on preventing depression outcomes in women with identified risk factors.
Depression: mother-infant relationship interventions versus treatment as usual
The evidence for mother–infant relationship interventions preventing depression in women with psychosocial risk factors or who had a preterm delivery and/or low birthweight baby was very inconsistent (Table 45). There was single study (N=106) evidence for large harms associated with mother–infant relationship interventions for women who had a preterm delivery (p=0.19-0.23), with the intervention group being one and a half to three times more likely to score above threshold on a depression scale (CES-D ≥16). However, the confidence in this effect estimate is very low due to risk of bias concerns (statistically significant group differences at baseline with the intervention group having more mothers with earlier preterm birth) and very serious imprecision (low event rate and 95% CI includes no effect and appreciable harm). In addition, there were contradictory effects observed for women with psychosocial risk factors, where there was single study (N=346) evidence for a moderate effect of a mother–infant relationship intervention on preventing depression diagnosis at long-term follow-up using an available case analysis approach (p=0.22). However, this effect was not statistically or clinically significant when an ITT analysis approach was used (p=1.00), and our confidence in the effect size from the available case analysis was low due to very serious imprecision (optimal information size [events=300] was not met and 95% CI includes no effect and appreciable benefit). In addition, there was no evidence for statistically or clinically significant effects of mother–infant relationship interventions on depression diagnosis at endpoint (p=0.36-0.99), depression symptomatology at long-term follow-up (p=0.62-0.82) or on mean depression symptoms at short-term follow-up (p=0.23) or long-term follow-up (p=0.18), and no evidence for clinically significant effects on depression mean symptoms at endpoint (p=0.03).
Table 45
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual on preventing depression outcomes in women with identified risk factors.
Depression: case management and individualized treatment versus treatment as usual
There was single study (N=34) evidence for a large effect (p=0.06) of case management and individualized treatment on preventing depression symptomatology for women who had a preterm delivery or low birthweight baby (Table 46), with women in the intervention group showing a 75% risk reduction for scoring above threshold on a depression scale (BDI ≥9). However, confidence in this effect estimate is very low due to risk of bias concerns (statistically significant group differences in maternal age at baseline with older mean age in the intervention group) and very serious imprecision (with very small sample size and 95% CI including both no effect and appreciable benefit).
Table 46
Summary of findings table for effects of case management and individualized treatment compared with treatment as usual on preventing depression outcomes in women with identified risk factors.
7.4.5. Clinical evidence for preventative effects on anxiety outcomes for women with identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Anxiety: post-miscarriage self-help versus treatment as usual
There was no evidence for clinically significant effects of post-miscarriage self-help on anxiety mean symptoms, although the effect was statistically significant (p=0.0005; Table 47).
Table 47
Summary of findings table for effects of post-miscarriage self-help compared with treatment as usual on preventing anxiety outcomes in women with identified risk factors.
Anxiety: non-mental health-focused education and support versus treatment as usual or enhanced treatment as usual
There was single study (N=162) evidence for a moderate effect of non-mental health-focused education and support for preventing anxiety symptomatology (at endpoint and short-term follow-up) in women with multiple births when an ITT analysis approach was used (p=0.17-0.25) and a large effect on anxiety symptomatology at short-term follow-up when an available case analysis was used (p=0.13). However, confidence in these effect estimates was very low due to very serious imprecision (low event rate and the 95% CI includes both no effect and appreciable benefit) and selective reporting bias, and the available case analysis for anxiety symptomatology at endpoint provided no evidence for an effect on this outcome measure (p=0.89). In addition, there was no evidence for statistically or clinically significant effects on anxiety mean scores at endpoint, short-term or intermediate follow-up (p=0.14-0.34), or on anxiety symptomatology at intermediate follow-up (0.32-0.93) (Table 48).
Table 48
Summary of findings table for effects of non-mental health-focused education and support compared with treatment as usual or enhanced treatment as usual on preventing anxiety outcomes in women with identified risk factors.
Anxiety: home visits versus treatment as usual
There was single study (N=120) evidence for moderate to large effects of home visits on preventing anxiety symptomatology at endpoint (p=0.01) and long-term follow-up (p=0.01-0.04), and large effects observed on mean anxiety symptoms at endpoint (p <0.0001) and moderate effects on mean anxiety symptoms at long-term follow-up (p=0.009) in women who had a preterm delivery (Table 49). However, confidence in these effect estimates is very low due to risk of bias concerns (statistically significant group differences in depression symptomatology at baseline and selective reporting) and imprecision (the optimal information size [events =300/N=400] was not met).
Table 49
Summary of findings table for effects of home visits compared with treatment as usual on preventing anxiety outcomes in women with identified risk factors.
7.4.6. Clinical evidence for preventative effects on PTSD outcomes for women with identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
PTSD: post-miscarriage self-help versus treatment as usual
There was single study evidence (N=228) for large effects of post-miscarriage self-help on preventing PTSD symptomatology (p=0.0004) and reducing mean PTSD symptoms (p <0.00001) for women who had lost a child during pregnancy because of miscarriage, termination due to medical indications, or stillbirth (Table 50). However, confidence in these effect estimates was very low due to risk of bias concerns (statistically significant difference in baseline mean scores [lower in the intervention group] on the intrusion subscale of the IES-R) and imprecision (the optimal information size [events =300/N=400] was not met).
Table 50
Summary of findings table for effects of post-miscarriage self-help compared with treatment as usual on preventing PTSD outcomes in women with identified risk factors.
7.4.7. Clinical evidence for preventative effects on poor general mental health outcomes for women with identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
General mental health: post-miscarriage self-help versus treatment as usual
There was single study evidence (N=228) for a moderate benefit of post-miscarriage self-help on preventing poor general mental health outcomes (p <0.00001) for women who had lost a child during pregnancy because of miscarriage, termination due to medical indications, or stillbirth. However, the confidence in this effect estimate was low due to risk of bias concerns (statistically significant group difference at baseline) and small sample size (Table 51).
Table 51
Summary of findings table for effects of post-miscarriage self-help compared with treatment as usual on preventing poor general mental health outcomes in women with identified risk factors.
General mental health: home visits versus treatment as usual
Two studies (N=207) provided no evidence for a clinically or statistically significant effect of home visits on preventing poor general mental health outcomes (p=0.49) in women with psychosocial risk factors and who were adolescent or had a (family) history of mental health problems (Table 52).
Table 52
Summary of findings table for effects of home visits compared with treatment as usual on preventing poor general mental health outcomes in women with identified risk factors.
General mental health: post-delivery discussion versus enhanced treatment as usual
A single study (N=534-917) failed to find evidence for clinically or statistically significant benefits of a midwife-led post-delivery discussion relative to a non-mental health-focused information booklet on preventing poor general mental health outcomes at post-treatment (p=0.22) or very long (208-312 weeks) follow-up (p=0.05) for women who had had an operative delivery (Table 53).
Table 53
Summary of findings table for effects of post-delivery discussion compared with enhanced treatment as usual on preventing poor general mental health outcomes in women with identified risk factors.
General mental health: mother-infant relationship interventions versus treatment as usual
A single study (N=88-125) found no evidence for clinically or statistically significant benefits of a mother–infant relationship intervention relative to treatment as usual on preventing poor general mental health outcomes at post-treatment (p=0.31) or long follow-up (p=0.66) for women who had a preterm delivery or a baby with low birthweight (Table 54).
Table 54
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual on preventing poor general mental health outcomes in women with identified risk factors.
7.4.8. Clinical evidence for preventative effects on poor mental health outcomes for women with identified risk factors (sub-analyses)
There was insufficient data to enable sub-analyses by risk factor, treatment timing, format or intensity for the prevention (risk factors identified) review.
7.4.9. Clinical evidence for preventative effects on mother–infant attachment problems for women with identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Mother-infant attachment: non-mental health-focused education and support versus treatment as usual or enhanced treatment as usual
A single study (N=126) found evidence for a moderate harm of non-mental health-focused education and support group and home visits relative to treatment as usual at short follow-up (p=0.32) for women with an uncomplicated twin pregnancy when an available case analysis approach was used (Table 55). However, confidence in this effect estimate was very low due to very serious imprecision (number of events fell below the threshold rule-of-thumb for optimal information size and the 95% CI included both no effect and measures of appreciable harm) and risk of selective reporting bias. This study (N=162) found no evidence for a clinically or statistically significant effect on this outcome measure at this time point when an ITT analysis approach was used (p=0.64). Moreover, no clinically or statistically significant effects were observed at post-treatment (N=133-162; p=0.52-0.97) or at intermediate follow-up (N=127-162; p=0.28-0.58).
Table 55
Summary of findings table for effects of non-mental health-focused education and support compared with treatment as usual or enhanced treatment as usual on preventing mother–infant attachment problems for women with identified risk factors.
Another single study (N=199-241) found evidence for small to moderate benefits of a non-mental health-focused education and support (booklet and audiotaped) intervention on preventing poor mother–infant interaction mean scores (p<0.0001) or poor maternal sensitivity (p=0.04) for mothers with babies in the neonatal intensive care unit (NICU) who had had preterm delivery and low birthweight babies (Table 55). However, confidence in these effect estimates was low to very low due to imprecision and selective reporting bias. This study found no evidence for a clinically or statistically significant effect of non-mental health-focused education and support on preventing poor maternal confidence (p=0.24).
Mother-infant attachment: home visits versus treatment as usual
There was single study (N=121-131) evidence for small and statistically significant benefits of home visits relative to treatment as usual for preventing poor maternal sensitivity (p=0.05) or poor infant involvement (p=0.02) for women with psychosocial risk factors and (family) history of mental health problems. However, these estimates did not meet the criteria for clinically appreciable benefits and confidence in the effect estimates was very low due to very serious imprecision and selective reporting bias (Table 56). This same study found no evidence for clinically or statistically significant effects of home visits on preventing the discontinuation of breastfeeding before 6 months (p=0.30).
Table 56
Summary of findings table for effects of home visits compared with treatment as usual on preventing mother–infant attachment problems for women with identified risk factors.
Mother-infant attachment: mother-infant relationship interventions versus treatment as usual
There was single study (N=318-449) low quality evidence for a moderate benefit of a mother–infant relationship intervention on preventing mother–infant attachment problems in women with psychosocial risk factors when an available case analysis approach was used (p=0.03). However, this effect was not clinically or statistically significant when an ITT (WCS) analysis approach was adopted (p=0.08). There was also evidence from two studies (N=172-175) for a small benefit of mother–infant relationship interventions on preventing poor mother–infant interaction mean scores (p=0.003) for women who had had a preterm delivery and/or a low birthweight baby. However, this effect estimate did not reach criteria for a clinically meaningful benefit (SMD<0.5), only available case analysis was reported, and confidence in the effect estimate was low as the sample size was below the threshold rule-of-thumb for the optimal information size (N=400). There was also evidence from the same two studies for moderate effects of mother–infant relationship interventions on preventing poor maternal sensitivity (p=0.10) and infant responsivity (p=0.38) mean scores. However, these effects were not statistically significant and the evidence was very low quality due to very serious imprecision and considerable heterogeneity (I2=80-92%). Single study analyses (N=109-112) failed to find evidence for clinically or statistically significant effects of mother–infant relationship interventions on preventing poor maternal intrusiveness (p=0.10), infant involvement (p=0.10) or infant negative engagement/behaviour problems (p=0.40) mean scores and effect size could not be estimated for maternal negative engagement due to zero count cells (Table 57).
Table 57
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual on preventing mother–infant attachment problems for women with identified risk factors.
Another single study (N=81-106) found evidence for clinically significant, or clinically and statistically significant, benefits of a mother–infant relationship intervention for preventing breastfeeding discontinuation before 6 months (p=0.17) or 9 months (p=0.03) for women who had had a preterm delivery when an available case analysis approach was used (Table 57). However, the quality of the evidence was very low and there was no evidence for clinically or statistically significant effects when an ITT analysis approach was used for preventing breastfeeding discontinuation before 6 months (p=0.62) or 9 months (p=0.09), and no clinically or statistically significant effects were observed for preventing breastfeeding discontinuation before 12 months when either an available case (p=0.08) or an ITT (p=0.12) analysis approach was used.
Mother-infant attachment: case management and individualized treatment versus treatment as usual
There was single study (N=30) very low quality evidence for a moderate benefit of case management and individualized treatment on preventing maternal sensitivity problems (p=0.08) for women who had had a preterm delivery and low birthweight baby (Table 58). However, this effect was not statistically significant due to very serious imprecision and there was a high risk of selection bias due to statistically significant group differences at baseline.
Table 58
Summary of findings table for effects of case management and individualized treatment compared with treatment as usual on preventing mother–infant attachment problems for women with identified risk factors.
7.4.10. Clinical evidence for preventative effects on poor quality of life outcomes for women with identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Quality of life: Psychologically (CBT/IPT)-informed psychoeducation versus treatment as usual or enhanced treatment as usual
A single study (N=190-209) found no evidence for clinically or statistically significant effects of CBT-informed psychoeducation relative to treatment as usual on preventing poor social support (p=0.61-0.78) for pregnant women with psychosocial risk factors (Table 59).
Table 59
Summary of findings table for effects of psychologically (CBT/IPT)-informed psychoeducation compared with treatment as usual or enhanced treatment as usual on preventing poor quality of life outcomes for women with identified risk factors.
Quality of life: non-mental health-focused education and support versus treatment as usual or enhanced treatment as usual
There was low quality evidence from two studies (N=369) for a small benefit of non-mental health-focused education and support (booklet and audiotaped or support group and home visits) on preventing high maternal stress (p=0.002) in women who had had a preterm delivery and low birthweight baby or women who had an uncomplicated twin pregnancy (Table 60). However, the threshold rule-of-thumb for the optimal information size (N=400) was not met and there was a high risk of selective reporting bias. Single study analyses (N=127-133) found very low quality evidence for a clinically and statistically significant benefit of a non-mental health-focused education and support group and home visits relative to treatment as usual on preventing poor social support at intermediate follow-up (p=0.004), a statistically but not clinically significant benefit at short-term follow-up (p=0.03), and no evidence of clinically or statistically significant benefits at post-treatment (p=0.20) for women with an uncomplicated twin pregnancy.
Table 60
Summary of findings table for effects of non-mental health-focused education and support compared with treatment as usual or enhanced treatment as usual on preventing poor quality of life outcomes for women with identified risk factors.
Quality of life: home visits versus treatment as usual
There was single study (N=29) evidence for a moderate benefit of home visits relative to treatment as usual for preventing poor social support (p=0.13) for women with psychosocial risk factors and (family) history of mental health problems (Table 61). However, this effect was not statistically significant due to very serious imprecision and there was a high risk of selective reporting bias. The same study (N=114) found no evidence for clinically or statistically significant benefits of home visits on preventing poor self-esteem (p=0.83).
Table 61
Summary of findings table for effects of home visits compared with treatment as usual on preventing poor quality of life outcomes for women with identified risk factors.
Quality of life: mother-infant relationship interventions versus treatment as usual
Two to three studies (N=183-244) found no evidence for clinically or statistically significant effects of mother–infant relationship interventions on preventing high parental stress at post-treatment (p=0.21) or long follow-up (p=0.92) for women who had had a preterm delivery and/or low birthweight baby (Table 62).
Table 62
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual on preventing poor quality of life outcomes for women with identified risk factors.
Quality of life: case management and individualized treatment versus treatment as usual
A single study (N=34) found no evidence for clinically or statistically significant benefits of case management and individualized treatment relative to treatment as usual for preventing high maternal stress (p=0.22) or poor self-esteem (p=0.39) for women who have had a preterm delivery and low birthweight baby (Table 63).
Table 63
Summary of findings table for effects of case management and individualized treatment compared with treatment as usual on preventing poor quality of life outcomes for women with identified risk factors.
7.4.11. Clinical evidence for preventative effects on service utilisation for women with identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Service utilisation: Psychologically (CBT/IPT)-informed psychoeducation versus treatment as usual or enhanced treatment as usual
A single study (N=190-209) found no evidence for clinically or statistically significant effects of CBT-informed psychoeducation relative to treatment as usual for preventing poor service utilisation (p=0.61-0.62) for women with psychosocial risk factors (Table 64).
Table 64
Summary of findings table for effects of psychologically (CBT/IPT)-informed psychoeducation compared with treatment as usual or enhanced treatment as usual on preventing poor service utilisation for women with identified risk factors.
Service utilisation: home visits versus treatment as usual
A single study (N=63) found very low quality evidence for a moderate benefit of home visits on preventing poor maternal contact with primary and/or secondary care for adolescent women with psychosocial risk factors when an available case analysis was adopted (p=0.26). However, this effect estimate was not statistically significant due to very serious imprecision and there was a high risk of selection bias. Moreover, this study (N=84) found no evidence for clinically or statistically significant effects of home visits on preventing poor maternal contact with primary and/or secondary care when an ITT analysis approach was used (p=0.60) (Table 65).
Table 65
Summary of findings table for preventative effects of home visits compared with treatment as usual on service utilisation for women with identified risk factors.
There was single study (N=131) evidence for a moderate benefit of home visits on preventing infant admissions to hospital (p=0.31) for women with psychosocial risk factors and (family) history of mental health problems (Table 65). However, confidence in this effect estimate was very low due to very serious imprecision (the event rate does not meet the rule-of-thumb threshold for optimal information size [Events<300] and the 95% CI includes no effect and measures of appreciable benefit and harm) and high risk of selective reporting bias. This same study found no evidence for a clinically or statistically significant effect of home visits on reducing infant length of stay in hospital (p=0.37).
7.4.12. Clinical evidence for preventative effects on experience of care for women with identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Experience of care: non-mental health-focused education and support versus treatment as usual or enhanced treatment as usual
A single study (N=141-162) found no evidence for clinically or statistically significant effects of non-mental health-focused education and support group and home visits relative to treatment as usual on preventing maternal dissatisfaction with care (p=0.09-0.15) for women with an uncomplicated twin pregnancy (Table 66).
Table 66
Summary of findings table for effects of non-mental health-focused education and support compared with treatment as usual or enhanced treatment as usual on preventing poor experience of care for women with identified risk factors.
7.4.13. Clinical evidence for preventative effects on poor retention in services and treatment unacceptability for women with identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Retention in services and treatment acceptability (using attrition as a proxy measure): post-miscarriage self-help versus treatment as usual
A single study (N=228) found no evidence for clinically or statistically significant effects of post-miscarriage self-help on attrition (p=0.59) (Table 67).
Table 67
Summary of findings table for effects of post-miscarriage self-help compared with treatment as usual on preventing poor retention in services or treatment unacceptability for women with identified risk factors.
Retention in services and treatment acceptability (using attrition as a proxy measure): social support versus treatment as usual
A single study (N=117) found evidence for a moderate harm associated with peer-mediated support (including one-to-one befriending and psychoeducational group meetings) with higher attrition in the intervention group relative to treatment as usual (p=0.15). However, this effect estimate was not statistically significant due to very serious imprecision (Table 68).
Table 68
Summary of findings table for effects of social support compared with treatment as usual on preventing poor retention in services or treatment unacceptability for women with identified risk factors.
Retention in services and treatment acceptability (using attrition as a proxy measure): Psychologically (CBT/IPT)-informed psychoeducation versus treatment as usual or enhanced treatment as usual
There was evidence from three studies (N=360) for a moderate harm associated with CBT- or IPT-informed psychoeducation (p=0.42) with higher attrition in the intervention group relative to treatment as usual or enhanced treatment as usual (non-mental health-focused education and support [booklet]). However, this effect was not statistically significant due to very serious imprecision (Table 69).
Retention in services and treatment acceptability (using attrition as a proxy measure): Psychoeducational booklet versus treatment as usual or enhanced treatment as usual
A single study (N=600) found no evidence for clinically or statistically significant effects of a psychoeducational booklet relative to treatment as usual on attrition (p=0.23) for women with psychosocial risk factors and (family) history of mental health problems (Table 70).
Table 70
Summary of findings table for effects of psychoeducational booklet compared with treatment as usual or enhanced treatment as usual on preventing poor retention in services or treatment unacceptability for women with identified risk factors.
Retention in services and treatment acceptability (using attrition as a proxy measure): non-mental health-focused education and support versus treatment as usual or enhanced treatment as usual
There was evidence from three studies (N=584) for a moderate benefit of non-mental health focused education and support on preventing poor retention in services or treatment unacceptability (using attrition as a proxy measure) for women with a range of identified risk factors (p=0.06). However, confidence in this effect estimate is very low due to a high risk of selection bias (statistically significant group difference at baseline) and very serious imprecision (threshold rule-of-thumb for optimal information size is not met and the 95% CI includes both no effect and measure of appreciable benefit) (Table 71).
Retention in services and treatment acceptability (using attrition as a proxy measure): home visits versus treatment as usual
Two studies (N=215) found no evidence for clinically or statistically significant effects of home visits relative to treatment as usual on attrition (p=0.54; Table 72).
Table 72
Summary of findings table for effects of home visits compared with treatment as usual on preventing poor retention in services or treatment unacceptability for women with identified risk factors.
Retention in services and treatment acceptability (using attrition as a proxy measure): post-delivery discussion versus enhanced treatment as usual
There was single study (N=1,041) evidence for a moderate effect of a midwife-led post-delivery discussion relative to enhanced treatment as usual (non-mental health-focused information [booklet]) on preventing poor retention in services and treatment unacceptability (using attrition as a proxy) for women who had had an operative delivery (p=0.09). However, this effect was not statistically significant due to very serious imprecision (Table 73).
Table 73
Summary of findings table for effects of post-delivery discussion compared with enhanced treatment as usual on preventing poor retention in services or treatment unacceptability for women with identified risk factors.
Retention in services and treatment acceptability (using attrition as a proxy measure): mother-infant relationship interventions versus treatment as usual
Four studies (N=772) found no evidence for clinically or statistically significant effects of mother–infant relationship interventions relative to treatment as usual on attrition (p=0.79) for women with psychosocial risk factors or who had had a preterm delivery and/or low birthweight baby (Table 74).
Table 74
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual on preventing poor retention in services or treatment unacceptability for women with identified risk factors.
7.4.14. Clinical evidence for preventative effects on infant physical health problems where mothers have identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Infant physical health: home visits versus treatment as usual
A single study (N=131) found low quality evidence for a large harm associated with home visits for women with psychosocial risk factors and (family) history of mental health problems, with a larger number of infants found with congenital malformations/disabilities (measured at 6 months) in the intervention relative to the control group (p=0.11). However, this effect was not statistically significant due to very serious imprecision (the threshold rule-of-thumb for the optimal information size, that is 300 events, was not met and the 95% CI includes no effect and measures of both appreciable benefit and appreciable harm) (Table 75).
Table 75
Summary of findings table for effects of home visits compared with treatment as usual on preventing poor physical health in infants where mothers have identified risk factors.
Another single study (N=79) found very low quality evidence for a moderate benefit of home visits for adolescent mothers with psychosocial risk factors in preventing infants being underweight (p=0.43). However, this effect was not statistically significant due to very serious imprecision and there are risk of bias concerns due to unclear selection and detection bias (Table 75). The same study (N=79-87) found no evidence for clinically or statistically significant effects of home visits on increasing the number of infants of normal weight (p=0.72) or preventing infants from being overweight (p=0.86) or preventing the incidence of severe diarrhoea for infants (p=0.81).
7.4.15. Clinical evidence for preventative effects on infant regulatory problems where mothers have identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Infant regulatory problems: mother-infant relationship interventions versus treatment as usual
A single study (N=63) found evidence for moderate to very large effects of a mother–infant relationship intervention relative to treatment as usual for mothers who had had a preterm delivery on preventing infant colic (at post-treatment [p <0.0001] and short-term follow-up [p <0.00001]), infant sleep problems (at post-treatment [p <0.00001] and short-term follow-up [p=0.02]), and infant excessive crying (at post-treatment [p <0.0001] but not at short-term follow-up [p=0.09]). However, confidence in these effect estimates is very low to very serious imprecision (very small sample size) and a high risk of selective reporting bias (Table 76).
Table 76
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual on preventing regulatory problems in infants where mothers have identified risk factors.
7.4.16. Clinical evidence for preventative effects on infant physical development problems where mothers have identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Infant physical development: home visits versus treatment as usual
Two studies (N=194) found evidence for a moderate effect of home visits, for adolescent mothers with psychosocial risk factors or mothers who had had a preterm delivery, for preventing delayed or impaired motor development when an available case analysis approach was used (p=0.54). However, confidence in this effect estimate was very low due to risk of bias concerns (statistically significant group difference at baseline), very serious imprecision (the rule-of-thumb threshold for optimal information size was not met [Events<300] and the 95% CI includes no effect and measures of both appreciable benefit and appreciable harm) and there was a high risk of selective reporting bias (Table 77). Moreover, a single study (N=96-120) found no evidence for clinically or statistically significant effects of home visits on preventing delayed or impaired motor development at long-term follow-up when an available case analysis approach was used (p=0.71) or at post-treatment (p=0.74) or long-term follow-up (p=0.82) when an ITT analysis approach was used, and up to two studies (N=96-194) found no evidence for clinically or statistically significant effects of home visits on preventing poor motor development mean scores at post-treatment (p=0.87) or long-term follow-up (p=0.88).
Table 77
Summary of findings table for effects of home visits compared with treatment as usual on preventing physical development problems in infants where mothers have identified risk factors.
7.4.17. Clinical evidence for preventative effects on infant cognitive development problems where mothers have identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Infant cognitive development: home visits versus treatment as usual
A single study (N=101) found evidence for a large harm associated with home visits for infants of women who had had a preterm delivery with a greater number of infants in the intervention group relative to treatment as usual showing nonverbal development impairment at post-treatment when an available case analysis approach was used (p=0.19). However, confidence in this effect estimate was very low due to high risk of selection and selective reporting bias and very serious imprecision, and the effect estimate for this outcome measure was not statistically or clinically significant when an ITT analysis approach was used (N=120; p=0.48). This same study (N=104) also found evidence for a large benefit associated with home visits on preventing infant verbal development impairment at long-term follow-up when an available case analysis was used (p=0.15), however, again confidence in this effect estimate was very low due to risk of bias concerns and very serious imprecision and the effect estimate was not clinically or statistically significant when an ITT analysis approach was used (p=0.46), or at post-treatment using either analysis approach (N=111-120; p=0.89-0.91). This study (N=99-120) found no evidence for clinically or statistically significant effects of home visits for preventing infant: cognitive development impairment (at post-treatment [p=0.74-0.94] or long-term follow [p=0.77-0.82]); poor cognitive development mean scores (at post-treatment [p=0.16] or long-term follow-up [p=0.65]); poor verbal development mean scores (at post-treatment [p=0.63] or long-term follow-up [p=0.15]); poor nonverbal development mean scores (at first measurement [p=0.30]); spatial reasoning impairment (at first measurement [p=0.94-0.96]); poor spatial reasoning mean scores (at first measurement [p=0.49]) (Table 78).
Table 78
Summary of findings table for effects of home visits compared with treatment as usual on preventing cognitive development problems in infants where mothers have identified risk factors.
7.4.18. Clinical evidence for preventative effects on infant emotional development problems where mothers have identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Infant emotional development: home visits versus treatment as usual
There was single study (N=97-120) evidence for small to large effects of home visits for women who had had a preterm delivery on preventing infant adaptive behaviour impairment (p=0.07), poor adaptive behaviour mean scores (p=0.02), externalizing impairment (p=0.08), higher externalizing mean scores (p=0.03) or internalizing impairment (p=0.44) at post-treatment and higher internalizing mean scores at long-term follow-up (p=0.02) when an available case analysis approach was used (Table 79). However, the effect estimates for the same outcome measures were not clinically or statistically significant when an ITT analysis approach was adopted (p=0.37-0.73). Effects on overall emotional development (impairment on one or more domain [p=0.03-0.005]) and dysregulation impairment (p=0.03-0.09) were, however, either clinically significant or both clinically and statistically significant using either analysis approach. There was also evidence for a large effect on preventing higher dysregulation mean scores (p=0.0001). However, confidence in all these effect estimates was very low due to a high risk of selection and selective reporting bias and very serious imprecision. This study found no evidence for clinically or statistically significant effects on preventing: higher internalizing mean scores (p=0.45) at post-treatment; adaptive behaviour impairment (p=0.37-0.60); poorer adaptive behaviour mean scores (p=0.35) at long-term follow-up; higher externalizing mean scores at long-term follow-up (p=0.80); internalizing impairment at long-term follow-up (p=0.48-0.63). There was evidence for a moderate harm associated with home visits on externalizing impairment at long-term follow-up when an available case analysis approach was used (p=0.43) but not when an ITT approach was adopted (p=0.97).
Table 79
Summary of findings table for effects of home visits compared with treatment as usual on preventing emotional development problems in infants where mothers have identified risk factors.
Infant emotional development: mother-infant relationship interventions versus treatment as usual
There was single study (N=63) evidence for a large harm associated with a mother-infant relationship intervention for women who had had a preterm delivery on preventing infant social withdrawal with infants in the intervention group showing worse scores than infants whose mothers had received treatment as usual (p<0.00001). However, confidence in this effect estimate was very low due to the very small sample size and the high risk of selective reporting bias. In addition, clinical and statistical significance of this effect estimate were not maintained at short-term follow-up (p=0.59) (Table 80).
Table 80
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual on preventing emotional development problems in infants where mothers have identified risk factors.
Another study (N=84) found no evidence for clinically or statistically significant effects of a mother-infant relationship intervention for mothers who had had a preterm delivery on preventing problems with infant social-communication development (p=0.88) (Table 80).
7.4.19. Clinical evidence for effects on prevention of neglect or abuse of the infant where mothers have identified risk factors for mental health problems (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Prevention of neglect or abuse of the infant: home visits versus treatment as usual
A single study (N=131) found evidence for large effects of home visits for women with psychosocial risk factors and (family) history of mental health problems on increasing the incidence of children being removed from the home (p=0.15) but reducing infant mortality (p=0.47). However, neither effect estimate was statistically significant due to very serious imprecision. The same study found no evidence for a clinically or statistically significant effect of home visits on preventing child protection issues (p=0.60). Another study (N=79) reported effects of home visits for adolescent mothers with psychosocial risk factors on preventing neglect or abuse of the infant, however, it was not possible to calculate an effect size due to zero cell counts (Table 81).
Table 81
Summary of findings table for effects of home visits compared with treatment as usual for prevention of neglect or abuse of the infant where mothers have identified risk factors for mental health problems.
7.4.20. Protocols for women following stillbirth
Depression for women who saw and/or held versus did not see and/or hold their stillborn infant
There was single study (N=65) data for large harms associated with seeing the stillborn infant for depression symptomatology during a subsequent pregnancy (p=0.08) and at one-year post-subsequent pregnancy follow-up (p=0.52). However, these effect estimates were imprecise due to low event rates and the 95% CI included no effect, appreciable benefit and appreciable harm. Another study with a much larger sample size (N=295) found no evidence for clinically or statistically significant harms associated with seeing (or not seeing) the stillborn infant on depression symptomatology 3 years post-stillbirth (p=0.59). Effects on depression mean symptoms were also not clinically or statistically significant (p=0.12-0.22) (Table 82).
Table 82
Summary of findings table for effects of seeing and/or holding and keeping mementoes compared with not seeing and/or holding the stillborn infant or keeping mementoes on depression outcomes.
The pattern of results was similar for depression outcomes associated with holding the stillborn infant, with single study (N=65) data for increased depression symptomatology during a subsequent pregnancy (p=0.03) or one-year post-subsequent pregnancy follow-up (p=0.16) associated with holding their stillborn infant. However, as before there are problems with imprecision of effect estimates and a larger study (N=295) found no evidence for increased risk of depression symptomatology 3-years post-stillbirth associated with holding (or not holding) their stillborn infant (p=0.99) (Table 82).
There was single study evidence for large benefits on depression symptomatology 3-years post-stillbirth of spending as much time with their stillborn infant as the woman wished (N=245; p <0.00001) but no evidence for clinically or statistically significant benefits or harms for depression symptomatology of keeping a photo of their stillborn infant (p=0.88), keeping a token of remembrance (p=0.51), or taking a drug to stop milk production following stillbirth (p=0.96) (Table 82).
Anxiety for women who saw and/or held versus did not see and/or hold their stillborn infant
There was single-study (N=65) evidence for clinically but not statistically significant harms of seeing or holding their stillborn infant on anxiety symptomatology during a subsequent pregnancy (p=0.19-0.21) or one-year post-subsequent pregnancy follow-up (p=0.08-0.64). This study also found a clinically and statistically significant moderate harm of seeing or holding the stillborn infant on mean anxiety symptoms during a subsequent pregnancy (p=0.03-0.05) though not at 1 year following the subsequent pregnancy (p=0.09-0.54). However, a larger single study (N=293) found no evidence for clinically or statistically significant harms (or benefits) of holding the stillborn infant on anxiety symptomatology 3-years post-stillbirth (p=0.73) (Table 83).
Table 83
Summary of findings table for effects of seeing and/or holding compared with not seeing and/or holding the stillborn infant on anxiety outcomes.
PTSD for women who saw and/or held versus did not see and/or hold their stillborn infant
There was single study (N=65) evidence for a large and harmful effect of seeing the stillborn infant on PTSD symptomatology during a subsequent pregnancy (p=0.15). However, this effect estimate is imprecise due to the optimal information size (events=300) not being met and the 95% CI includes no effect, appreciable benefit and appreciable harm. This study also found a large harmful effect of seeing the stillborn infant on mean PTSD symptoms one-year post-subsequent pregnancy follow-up (p=0.003) but not during the subsequent pregnancy (p=0.16). This study also found large harms associated with holding the stillborn infant on PTSD symptomatology during a subsequent pregnancy (p=0.07), and large to moderate harms of holding the stillborn infant for mean PTSD symptoms during a subsequent pregnancy (p=0.02) and at 1-year (p=0.0002) and 7-year (p=0.009) post-subsequent pregnancy follow-ups. However, another study (N=98) found large benefits associated with holding the stillborn infant on PTSD symptomatology 5-18 years post-stillbirth (p=0.0009) (Table 84).
Table 84
Summary of findings table for effects of seeing and/or holding compared with not seeing and/or holding the stillborn infant on PTSD outcomes.
Summary of evidence for protocols for women following stillbirth
The evidence for benefits or harms associated with seeing and/or holding the stillborn infant was contradictory with evidence from HUGHES2002/TURTON2009 suggestive of harms associated with these protocols following stillbirth and evidence from RADESTAD2009A/SURKAN2008 and GRAVENSTEEN2013 suggestive of benefits associated with spending as much time with the stillborn infant as women wished or holding the stillborn infant. In addition, data could not be extracted for CACCIATORE2008 but narrative review of this study is consistent with the equivocal findings. Unfortunately, there is insufficient data to allow for sub-analyses. However, potential reasons for these differences could be differences in gestational age at the time of stillbirth. None of the papers report the mean gestational age at stillbirth, however, differences in the inclusion criteria are potentially consistent with more negative effects associated with these protocols for stillbirths occurring at earlier gestational ages (for instance, the inclusion criteria for HUGHES2002/TURTON2009 is >18 weeks compared to the inclusion criteria for RADESTAD2009A/SURKAN2008 which is >28 weeks). Another potential confounding factor and possible explanation for the mixed results is pregnancy status at the time of participation in the studies and more negative effects associated with seeing and/or holding the stillborn infant observed during a subsequent pregnancy (as in HUGHES2002/TURTON2009) as compared to women who were not pregnant at the time of the study (as in GRAVENSTEEN2013). Narrative review of CACCIATORE2008 supports the hypothesis that pregnancy status may account for some of the between-study differences as that study found that seeing and/or holding their stillborn infant was associated with lower levels of depression for women who were non-pregnant when completing the questionnaire, while for women who were pregnant subsequent to a stillbirth seeing and/or holding was associated with a tendency towards depression.
7.4.21. Studies considered (prevention: no identified risk factors)
Seven RCTs reported across ten papers met the eligibility criteria for this review: HOWELL2014 (Howell et al., 2014), KALINAUSKIENE2009 (Kalinauskiene et al., 2009), LAVENDER1998 (Lavender & Walkinshaw, 1998), MORRELL2000 (Morrell et al., 2000), MORRELL2009A/2009B/2011/BRUGHA2011 (Morrell et al., 2009a; Morrell et al., 2009b; Morrell et al., 2011; Brugha et al., 2011), PEREZBLASCO2013 (Perez-Blasco et al., 2013), TSENG2010 (Tseng et al., 2010). All of these studies were published in peer-reviewed journals between 1998 and 2013. In addition, 28 studies were excluded from the review. The most common reasons for exclusion were that data could not be extracted, there were no mental health outcomes reported, the group assignment was non-randomised, or the intervention was outside the scope (for instance, organisation of care trials). Further information about both included and excluded studies can be found in Appendix 18.
Of the seven included RCTs, there was one study (N=2,324) involving a comparison of a structured psychological intervention (CBT) and treatment as usual (Table 85).
Table 85
Study information table for trials included in the prevention (no risk factors identified) meta-analysis of structured psychological interventions (CBT or IPT) versus any alternative management strategy.
There was one study (N=2,297) that compared listening visits with treatment as usual (Table 86).
Table 86
Study information table for trials included in the prevention (no risk factors identified) meta-analysis of counselling versus any alternative management strategy.
There were two studies (N=1,978) that involved a comparison between psychologically (CBT/IPT)-informed psychoeducation and enhanced treatment as usual, one study (N=623) involved a comparison of home visits and treatment as usual, and one study (N=120) compared post-delivery discussion and treatment as usual (Table 87).
Table 87
Study information table for trials included in the prevention (no risk factors identified) meta-analysis of education and support versus any alternative management strategy.
One study (N=54) compared a mother–infant relationship intervention and enhanced treatment as usual (Table 88). Although the participants in this study did not meet criteria for the pre-specified risk factors, the mothers were classified as ‘insensitive’ at baseline (defined as score<5 [midpoint] on Ainsworth rating scale for sensitivity).
Table 88
Study information table for trials included in the prevention (no risk factors identified) meta-analysis of mother–infant relationship interventions versus any alternative management strategy.
Finally, there was one study (N=92) that involved a comparison between music therapy and treatment as usual and one study (N=26) compared mindfulness training with treatment as usual (Table 89).
Table 89
Study information table for trials included in the prevention (no risk factors identified) meta-analysis of other psychosocial interventions versus any alternative management strategy.
7.4.22. Clinical evidence for preventative effects on depression outcomes for women with no identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Depression: structured psychological interventions (CBT or IPT) versus treatment as usual
There was single study (N=1,762) available case analysis evidence for a moderate effect of CBT relative to treatment as usual for preventing depression symptomatology in women in the postnatal period with no identified risk factors (p=0.004). However, the ITT analysis of the same outcome measure showed no evidence of statistically or clinically significant preventative effects (p=0.97). There was also no evidence for a clinically significant effect (although it was statistically significant [p <0.00001]) on mean depression symptoms (Table 90).
Table 90
Summary of findings table for effects of structured psychological interventions (CBT or IPT) compared with treatment as usual on preventing depression outcomes in women with no identified risk factors.
Depression: listening visits versus treatment as usual
Using an available case analysis approach, there was single study (N=1,811) evidence for a moderate preventative effect of listening visits on depression symptomatology for women in the postnatal period with no identified risk factors (p=0.007). However, the ITT analysis for depression symptomatology revealed no clinically significant difference between listening visits and treatment as usual, although the difference was statistically significant (p=0.01). For depression mean scores there was also a statistically significant (p <0.0001) but not an appreciable benefit of listening visits (Table 91).
Table 91
Summary of findings table for effects of listening visits compared with treatment as usual on preventing depression outcomes in women with no identified risk factors.
Depression: Psychologically (CBT/IPT)-informed psychoeducation versus enhanced treatment as usual
There was no evidence for statistically or clinically significant benefits of psychoeducation for preventing depression in the postnatal period for women with no identified risk factors (p=0.51-0.99; Table 92).
Table 92
Summary of findings table for effects of psychologically (CBT/IPT)-informed psychoeducation compared with enhanced treatment as usual on preventing depression outcomes in women with no identified risk factors.
Depression: home visits versus treatment as usual
There was no evidence for statistically or clinically significant benefits of home visits relative to treatment as usual for reducing mean depression symptoms at 6 weeks (p=0.13) or 6 months (p=0.84) postnatally for women with no identified risk factors (Table 93).
Table 93
Summary of findings table for effects of home visits compared with treatment as usual on preventing depression outcomes in women with no identified risk factors.
Depression: post-delivery discussion versus treatment as usual
There was single study (N=114) evidence for a large effect of post-delivery discussion relative to treatment as usual for preventing depression symptomatology in the postnatal period for women with no identified risk factors (p <0.0001). However, the confidence in this effect estimate is low due to very serious imprecision as the optimal information size (events=300) is not met (Table 94).
Table 94
Summary of findings table for effects of post-delivery discussion compared with treatment as usual on preventing depression outcomes in women with no identified risk factors.
Depression: mother-infant relationship interventions versus enhanced treatment as usual
There was no evidence for statistically or clinically significant benefits of mother– infant relationship interventions relative to monitoring for reducing mean depression symptoms in the postnatal period for women with no identified risk factors (p=0.32; Table 95).
Table 95
Summary of findings table for effects of mother–infant relationship interventions compared with enhanced treatment as usual on preventing depression outcomes in women with no identified risk factors.
Depression: mindfulness training versus treatment as usual
There was no evidence for statistically or clinically significant benefits of mindfulness training relative to treatment as usual for reducing depression mean symptoms in the postnatal period for women with no identified risk factors (p=0.42; Table 96).
Table 96
Summary of findings table for effects of mindfulness training compared with treatment as usual on preventing depression outcomes in women with no identified risk factors.
7.4.23. Clinical evidence for preventative effects on anxiety outcomes for women with no identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Anxiety: structured psychological interventions (CBT or IPT) versus treatment as usual
There was no evidence for clinically significant benefits of CBT relative to treatment as usual for reducing anxiety symptoms (state and trait) in the postnatal period for women with no identified risk factors, although the effects were statistically significant (p=0.007-0.01) they were too small to be considered clinically meaningful (Table 97).
Table 97
Summary of findings table for effects of structured psychological interventions (CBT or IPT) compared with treatment as usual on preventing anxiety outcomes in women with no identified risk factors.
Anxiety: listening visits versus treatment as usual
Although statistically significant benefits of listening visits for reducing postnatal state and trait anxiety symptoms were observed (p=0.03-0.04), the effect sizes were too small to be considered as showing an appreciable clinical benefit (Table 98).
Table 98
Summary of findings table for effects of listening visits compared with treatment as usual on preventing anxiety outcomes in women with no identified risk factors.
Anxiety: post-delivery discussion versus treatment as usual
There was single study (N=114) evidence for a large effect of a post-delivery discussion on preventing anxiety symptomatology in the postnatal period for women with no identified risk factors (p <0.0001). However, the confidence in this effect estimate is low due to very serious imprecision conferred by a low event rate (Table 99).
Table 99
Summary of findings table for effects of post-delivery discussion compared with treatment as usual on preventing anxiety outcomes in women with no identified risk factors.
Anxiety: music therapy versus treatment as usual
There was no evidence for statistically or clinically significant effects of music therapy for reducing anxiety symptoms in the postnatal period for women with no identified risk factors (p=0.07; Table 100).
Table 100
Summary of findings table for effects of music therapy compared with treatment as usual on preventing anxiety outcomes in women with no identified risk factors.
Anxiety: mindfulness training versus treatment as usual
There was single study (N=21) evidence for a very large effect of mindfulness training on reducing anxiety symptoms in the postnatal period for women with no identified risk factors (p=0.01). However, confidence in this effect estimate was low due to very serious imprecision as a result of the very small sample size (Table 101).
Table 101
Summary of findings table for effects of mindfulness training compared with treatment as usual on preventing anxiety outcomes in women with no identified risk factors.
7.4.24. Clinical evidence for preventative effects on poor general mental health outcomes for women with no identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
General mental health: structured psychological interventions (CBT or IPT) versus treatment as usual
There was single study (N=1,749) moderate quality evidence for a moderate benefit of CBT relative to treatment as usual, for women in the postnatal period with no identified risk factors, on lower risk of self-harm (Table 102). The same study (N=1,700) found no clinically significant benefit (although the effect was statistically significant) of CBT on preventing poor general mental health mean scores (p=0.002).
Table 102
Summary of findings table for effects of structured psychological interventions (CBT or IPT) compared with treatment as usual on preventing poor general mental health outcomes in women with no identified risk factors.
General mental health: listening visits versus treatment as usual
There was single study (N=1,799) moderate quality evidence for a moderate benefit of listening visits relative to treatment as usual, for women in the postnatal period with no identified risk factors, on lower risk of self-harm (Table 103). The same study (N=1,764) found no clinically significant benefit (although the effect was statistically significant) of listening visits on preventing poor general mental health mean scores (p=0.001).
Table 103
Summary of findings table for effects of listening visits compared with treatment as usual on preventing poor general mental health outcomes in women with no identified risk factors.
General mental health: home visits versus treatment as usual
A single study (N=481-550) found no evidence for clinically or statistically significant effects of home visits for women in the postnatal period with no identified risk factors for preventing poor general mental health mean scores at post-treatment (p=0.64) or intermediate follow-up (p=0.45) (Table 104).
Table 104
Summary of findings table for effects of home visits compared with treatment as usual on preventing poor general mental health outcomes in women with no identified risk factors.
General mental health: mindfulness training versus treatment as usual
There was single study (N=21) evidence for a large effect of mindfulness training for women in the postnatal period with no identified risk factors on preventing psychological distress (p=0.02). However, confidence in this effect estimate is low due to very serious imprecision (very small sample size). The same study found no evidence for clinically or statistically significant effects of mindfulness training on life satisfaction (p=0.35) or happiness (p=0.60) (Table 105).
Table 105
Summary of findings table for effects of mindfulness training compared with treatment as usual on preventing poor general mental health outcomes in women with no identified risk factors.
7.4.25. Clinical evidence for preventative effects on poor mental health outcomes for women with no identified risk factors (sub-analyses)
There was insufficient data to enable sub-analyses by treatment timing, format or intensity for the prevention (no risk factors identified) review.
7.4.26. Clinical evidence for preventative effects on mother–infant attachment problems for women with no identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Mother-infant attachment: home visits versus treatment as usual
A single study (N=493-548) found no evidence for clinically or statistically significant effects of home visits for women in the postnatal period with no identified risk factors on preventing breastfeeding discontinuation before 6 weeks (p=0.50) or before 6 months (p=0.87) (Table 106).
Table 106
Summary of findings table for effects of home visits compared with treatment as usual on preventing mother–infant attachment problems for women with no identified risk factors.
Mother-infant attachment: mother-infant relationship intervention versus enhanced treatment as usual
There was single study (N=54) low quality evidence for a moderate effect of a mother–infant relationship intervention relative to enhanced treatment as usual (monitoring) for women in the postnatal period with no identified risk factors on preventing poor maternal sensitivity scores (p=0.007). However, this study found no clinically or statistically effects of a mother–infant relationship intervention on child attachment security (p=1.00) or maternal confidence/competence (p=0.28) (Table 107).
Table 107
Summary of findings table for effects of a mother–infant relationship intervention compared with enhanced treatment as usual on preventing mother–infant attachment problems for women with no identified risk factors.
Mother-infant attachment: mindfulness training versus treatment as usual
There was single study (N=21) low quality evidence for a large benefit of mindfulness training for women in the postnatal period with no identified risk factors on maternal confidence/competence (p=0.002) (Table 108).
Table 108
Summary of findings table for effects of mindfulness training compared with treatment as usual on preventing mother–infant attachment problems for women with no identified risk factors.
7.4.27. Clinical evidence for preventative effects on poor quality of life outcomes for women with no identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Quality of life: structured psychological interventions (CBT or IPT) versus treatment as usual
A single study (N=1,299-1,749) found no evidence for clinically significant benefits (despite statistical significance) of CBT for women in the postnatal period with no identified risk factors on maternal stress (p=0.03), impaired life functioning (p=0.07) or wellbeing (p=0.002) (Table 109).
Table 109
Summary of findings table for effects of structured psychological interventions (CBT or IPT) compared with treatment as usual on preventing poor quality of life outcomes for women with no identified risk factors.
Quality of life: listening visits versus treatment as usual
A single study (N=1,407-1,800) found no evidence for clinically significant benefits (despite statistical significance) of listening visits for women in the postnatal period with no identified risk factors on maternal stress (p=0.002), impaired life functioning (p=0.08) or wellbeing (p=0.002) (Table 110).
Table 110
Summary of findings table for effects of listening visits compared with treatment as usual on preventing poor quality of life outcomes for women with no identified risk factors.
Quality of life: home visits versus treatment as usual
A single study (N=465-513) found no evidence for clinically or statistically significant effects of home visits for women in the postnatal period with no identified risk factors on social support at post-treatment (p=0.87) or at intermediate follow-up (p=0.54) (Table 111).
Table 111
Summary of findings table for effects of home visits compared with treatment as usual on preventing poor quality of life outcomes for women with no identified risk factors.
Quality of life: mother-infant relationship intervention versus enhanced treatment as usual
A single study (N=54) found no evidence for a clinically or statistically significant effect of a mother–infant relationship intervention relative to enhanced treatment as usual (monitoring) for women in the postnatal period with no identified risk factors on maternal stress (p=0.14) (Table 112).
Table 112
Summary of findings table for effects of a mother–infant relationship intervention compared with enhanced treatment as usual on preventing poor quality of life outcomes for women with no identified risk factors.
Quality of life: music therapy versus treatment as usual
A single study (N=77) found no evidence for a clinically or statistically significant effect of music therapy relative to treatment as usual for women in the postnatal period with no identified risk factors on maternal stress (p=0.51) (Table 113).
Table 113
Summary of findings table for effects of music therapy compared with treatment as usual on preventing poor quality of life outcomes for women with no identified risk factors.
Quality of life: mindfulness training versus treatment as usual
A single study (N=21) found low quality evidence for a large benefit of mindfulness training relative to treatment as usual for women in the postnatal period with no identified risk factors on maternal stress (p=0.02) (Table 114).
Table 114
Summary of findings table for effects of mindfulness training compared with treatment as usual on preventing poor quality of life outcomes for women with no identified risk factors.
7.4.28. Clinical evidence for preventative effects on poor retention in services and treatment unacceptability for women with no identified risk factors (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Retention in services and treatment acceptability (using attrition as a proxy measure): structured psychological interventions (CBT or IPT) versus treatment as usual
There was single study evidence (N=2,324) for harms associated with CBT (indicative of poorer retention in services and lower treatment acceptability) for women in the postnatal period with no identified risk factors with higher attrition for women in the intervention group than in the control group (p=0.004) (Table 115).
Table 115
Summary of findings table for effects of structured psychological interventions (CBT or IPT) compared with treatment as usual on preventing poor retention in services or treatment unacceptability for women with no identified risk factors.
Retention in services and treatment acceptability (using attrition as a proxy measure): listening visits versus treatment as usual
A single study (N=2,297) found no clinically or statistically significant effects of listening visits for women in the postnatal period with no identified risk factors on attrition (p=1.00) (Table 116).
Table 116
Summary of findings table for effects of listening visits compared with treatment as usual on preventing poor retention in services or treatment unacceptability for women with no identified risk factors.
Retention in services and treatment acceptability (using attrition as a proxy measure): Psychologically (CBT/IPT)-informed psychoeducation versus enhanced treatment as usual
A single study (N=540) found no evidence for clinically or statistically-significant effects of a psychologically (CBT/IPT)-informed psychoeducational intervention relative to enhanced treatment as usual (non-mental health-focused education and support [booklet and telephone call]) for women in the postnatal period with no identified risk factors on attrition (p=0.74) (Table 117).
Table 117
Summary of findings table for effects of psychologically (CBT/IPT)-informed psychoeducation compared with enhanced treatment as usual on preventing poor retention in services or treatment unacceptability for women with no identified risk factors.
Retention in services and treatment acceptability (using attrition as a proxy measure): home visits versus treatment as usual
A single study (N=623) found very low quality evidence for moderate benefits of home visits relative to treatment as usual for women in the postnatal period with no identified risk factors on preventing poor retention in services and treatment unacceptability, using attrition as a proxy (p=0.08) (Table 118).
Table 118
Summary of findings table for effects of home visits compared with treatment as usual on preventing poor retention in services or treatment unacceptability for women with no identified risk factors.
Retention in services and treatment acceptability (using attrition as a proxy measure): mindfulness training versus treatment as usual
There was single study evidence (N=26) for harms associated with mindfulness training (indicative of poorer retention in services and lower treatment acceptability) for women in the postnatal period with no identified risk factors with higher attrition for women in the intervention group than for women who received treatment as usual (p=0.09). However, confidence in this effect estimate was low due to very serious imprecision (Table 119).
Table 119
Summary of findings table for effects of mindfulness training compared with treatment as usual on preventing poor retention in services or treatment unacceptability for women with no identified risk factors.
7.4.29. Health economic evidence
Systematic literature review
The systematic literature search identified two eligible UK studies (Barlow et al., 2007 and McIntosh et al., 2009; Petrou et al., 2006), one study conducted in Chile (Aracena et al., 2009) and one in Australia (Hiscock et al., 2007) that assessed prevention interventions for developing mental health problems in pregnancy or the postnatal period. Details on the methods used for the systematic search of the economic literature are described in Chapter 3. References to included studies and evidence tables for all economic studies included in the guideline systematic literature review are presented in Appendix 21. Completed methodology checklists of the studies are provided in Appendix 20. Economic evidence profiles of studies considered during guideline development (that is, studies that fully or partly met the applicability and quality criteria) are presented in Appendix 22, accompanying the respective GRADE clinical evidence profiles.
Barlow and colleagues (2007) evaluated the cost effectiveness of a home visiting programme compared with standard care in vulnerable pregnant women. Women were screened using a range of demographic and socioeconomic criteria (for example, presence of mental health problems or housing problem). The programme involved health visitors trained in the Nurse-Family Partnership Model providing intensive weekly home visiting services from 6 months antenatally to 12 months after childbirth. Standard care was defined as locally available services. This was an economic evaluation undertaken alongside an RCT (BARLOW2007) (n=131) conducted in the UK. The study by McIntosh and colleagues (2009) is based on the same RCT but reports additional analyses. The main analysis was conducted from a public sector perspective plus informal care but authors conducted sensitivity analyses considering a healthcare perspective. The study considered a range of direct healthcare costs including primary and secondary care, direct non-healthcare costs (that is, social worker, alcohol/drug support, child and family team, foster care, adoption services, family centre, Sure Start, Home Start); also the costs accruing to Housing department, legal advice centre, Citizens Advice Bureau, court and to the police; and childcare costs (that is, crèche, playgroup and private childcare). The resource use estimates were based on the RCT and other published sources. The unit costs were obtained from local and national sources. The measure of outcome for the economic analysis was the proportion of infants identified as being ill-treated on the basis of child protection proceedings between 6 and 12 months after childbirth, improvement in maternal sensitivity and infant cooperativeness components of CARE-Index scores; and time of infant exposure to abuse and neglect. The CARE-Index is a measure that assesses mother–infant interaction from birth to about two years of age based on a short, videotaped play interaction of 3-5 minutes. The measure assesses mothers on three scales: sensitivity, control and unresponsiveness. There are also four scales for infants: cooperativeness, compulsivity, difficultness, and passivity. The time horizon of the main analysis was 18 months, however when using the time of infant exposure to abuse and neglect as an outcome of the economic analysis costs were modelled for 5 years. The authors assumed that exposure to abuse and neglect would continue throughout the preschool period, and that the neglect would be identified as soon as the child went to school at the age of 5 years (for example, assuming that neglect was identified when the child was 6 months old, intervention would have prevented 4.5 years of abuse and neglect); the costs considered over this period of time included foster care and adoption costs.
The intervention resulted in a greater proportion of infants being identified as ill-treated between 6 and 12 months compared with standard care, (0.059 versus 0.000, respectively; difference 0.059, p value was non-significant); improvement in maternal sensitivity component of CARE-Index score: 9.27 versus 8.20 for intervention and standard care, respectively (difference of 1.07 points); improvement in infant cooperativeness component of CARE-Index score: 9.35 and 7.92 for intervention and standard care, respectively (difference of 1.43 points). For a reduction in time of exposure to abuse the difference was 1.9 months in favour of the intervention. From a public sector perspective (and informal care) the mean total costs per mother– infant dyad over 18 months were £7,120 for the intervention and £3,874 for standard care, a difference of £3,246 (p <0.05) in 2003/04 prices. Similarly, when considering only health service costs, the mean total costs per mother–infant dyad over 18 months were £5,685 for intervention and £3,324 for standard care, a difference of £2,360 (p <0.05).
From a public sector perspective (and informal care) the cost per extra infant identified as being ill-treated was £55,016; per extra unit of improvement on maternal sensitivity and infant cooperativeness components of CARE-Index it was £2,723 and £2,023, respectively; and £1,691 per additional month reduced of infant exposure to abuse and neglect. From a healthcare perspective the cost per extra infant identified as being ill-treated was £40,000; per extra unit of improvement on maternal sensitivity and infant cooperativeness components of CARE-Index it was £2,178 and £1,621, respectively; and £1,229 for a reduction in infant exposure to abuse and neglect by one month.
From a public sector perspective (and informal care) probabilistic analysis indicated that at a willingness-to-pay (WTP) of £16,100 per unit improvement on the maternal sensitivity component of CARE-Index the probability that the intervention is cost effective was 0.95 and at WTP of £4,000 per unit improvement on infant cooperativeness component of CARE-Index the probability that the intervention is cost effective was 0.95. Moreover, at WTP of £1,400 for a reduction in infant exposure to abuse and neglect by one month the probability that the intervention is cost effective was 0.75 and at WTP £3,100 this probability increased to 0.95. From a healthcare perspective when WTP is £13,900 and £2,700 per unit improvement on maternal sensitivity component of CARE-Index and on infant cooperativeness component of CARE-Index, respectively, the probability that intervention is cost effective was 0.95. Deterministic sensitivity analyses were very limited and were conducted only on the ICER estimated from a public sector perspective plus informal care. It was found that ranging the proportion of infants identified as being ill-treated from 0.03 to 0.13 (base-case 0.06), the cost for a reduction in infant exposure to abuse and neglect by one month ranged from £2,505 to £1,284. Overall results suggest that intervention provides better outcomes however at an additional cost.
The analysis was judged by the GDG to be partially applicable to this guideline review and the NICE reference case. In the base case analysis the authors explored the cost effectiveness from a public sector perspective (plus informal care). Moreover, the authors did not attempt to estimate QALYs which made it difficult to interpret the cost-effectiveness results and to compare the findings with other studies. Also, the sensitivity analysis was very limited. However, overall, given the data limitations in this area, this was a well conducted study and was judged by the GDG to have only minor methodological limitations.
Petrou and colleagues (2006) evaluated the cost effectiveness of listening visits compared with standard care. Standard care was defined as care provided by local primary care teams. The intervention entailed research therapists visiting women in their homes at 35 and 37 weeks antenatally; on days 3, 7, and 17 after childbirth, and then weekly up to 8 weeks. Study population comprised women at high risk of developing depression in the postnatal period [women who scored ≥ 24 on the predictive index developed by Cooper and colleagues (1996) at 26-28 weeks of gestation]. This was an economic evaluation undertaken alongside an RCT (n=151) conducted in the UK. The time horizon of the analysis was 18 months; healthcare and informal care costs were considered. The study estimated a range of costs including community care, day care, hospital outpatient and inpatient care, paediatric care, child care and home help. The authors did not report healthcare costs separately, consequently it was not possible to estimate costs from the NHS and PSS perspective. The resource use estimates were based on the RCT (n=151) and the unit costs were obtained from local and national sources. The measure of outcome for the economic analysis was the number of months in depression in the postnatal period. In the analysis, costs and health effects beyond 12 months were discounted at an annual rate of 6% and 1.5%, respectively.
At 18 months the intervention resulted in fewer months of depression in the postnatal period per woman, 2.21 months versus 2.70 months, difference of -0.49 months (p=0.41). The mean cost per mother–infant dyad over 18 months was £2,397 for the intervention and £2,278 for standard care in 2000 prices, difference of £120 (p=0.72). The cost per month in depression avoided was estimated to be £244. The authors also conducted a range of sensitivity analyses. According to the deterministic sensitivity analysis when varying community service utilisation from 10 to 30% the ICER ranged from £422 to £780; when increasing or decreasing per diem cost for inpatient care by 20% the ICER ranged from £41 to £446; when ranging the discount rate for costs and health effects from 0% to 10% the ICER ranged from £351 to £198; and when setting discount rate for costs and health effects at 3% the ICER increased to £302 per month of depression avoided. Probabilistic analysis indicated that at WTP of £1,000 and £2,000 per month of depression avoided the probability of the intervention being cost effective was 0.71 and 0.77, respectively. Results suggest that intervention provides better outcome at an additional cost, although the differences in costs and clinical outcomes were not statistically significant.
The analysis was judged by the GDG to be partially applicable to this guideline review and the NICE reference case. The authors included some cost categories that are not relevant to the NHS and PSS perspective (that is, informal care) and some of the unit costs were derived from local sources which may limit the generalisability of the findings. Also, NICE recommends discounting both costs and health effects at an annual rate of 3.5%, but in the analysis a discount rate of 6% and 1.5% was used for costs and health effects, respectively. Nevertheless, as indicated by the sensitivity analysis the discount rate had a minimal effect on the ICER. The estimate of relative treatment effect was obtained from a single RCT and the authors have not attempted to estimate QALYs, which made it difficult to interpret the cost-effectiveness results and to compare the findings with other studies. Overall this was a well conducted study and was judged by the GDG to have only minor methodological limitations.
Aracena and colleagues (2009) evaluated the cost effectiveness of home visiting service compared with standard care in Chile. The intervention involved home visits from health educators, starting in the third trimester of pregnancy and continuing until the child reached 1 year of age; in total, the women had 12 home visits of 1 hour each throughout the year. Standard care was defined as standard prenatal and well-baby care at local health centres and consisted of ten prenatal consultations with midwife at the local health centres. The study population comprised of young women from low socioeconomic backgrounds who conceived their first child when they were between 14-19 years old. This was an economic evaluation undertaken alongside an RCT (ARACENA2009) (n=90). The time horizon of the analysis was 15 months and the perspective of the healthcare payer was adopted. The study estimated healthcare, administrative and logistical costs. The resource use estimates were based on registries of health centres, and the source of unit costs was not specified. The measure of outcome for the economic analysis was an improvement in the Goldberg's Depression Scale score. Neither costs nor health effects were discounted in the economic analysis, but such discounting was not necessary because the time horizon was 15 months.
Over 15 months the intervention resulted in an improvement in Goldberg's Depression Scale score: 10.94 (SD 5.85) versus 13.85 (SD 6.99), intervention and standard care groups, respectively (difference of -2.91 points, p=0.031). The costs in the study were measured in US dollars and the cost year was not reported. The median cost per mother–infant dyad at 15 months was $90 for the intervention and $50 for the standard care group, showing a difference of $40. The cost per additional score reduction on the Goldberg's Depression Scale was estimated to be $13.50. Results suggest that home visits provide the better outcome; however, this comes at an additional cost.
The GDG considered the analysis to be partially applicable to this guideline review and the NICE reference case. The study was conducted in Chile and the type of healthcare costs considered in the analysis are unclear. Moreover, the authors did not attempt to estimate QALYs, which made it difficult to interpret the cost-effectiveness results and to compare the findings with other studies. The estimate of relative treatment effect was obtained from a single RCT, the resource use estimates were derived from registries of local health centres which may limit the generalisability of the findings to the UK setting; and the source of unit costs was unclear. Also, statistical analysis was done only for outcomes and not for costs. As a result, this study was judged by the GDG to have potentially serious methodological limitations.
Hiscock and colleagues (2007) evaluated the cost effectiveness of an infant sleep training intervention compared with standard care. This was an economic evaluation undertaken alongside an RCT (HISCOCK2002 [Hiscock & Wake, 2002]) (n=328) conducted in Australia. Infant sleep intervention entailed mothers attending three consultations at their local maternal and child health centres. Mothers were given a choice of two behavioural interventions: (1) ‘controlled crying’ whereby parents respond to their infant's cry at increasing time intervals, to allow independent settling or (2) ‘camping out’ sitting with the infant until they fall asleep and gradually removing parental presence over 3 weeks. In standard care group mothers were given an infant sleep leaflet only. The study population comprised mothers of 4-month-old infants attending a consultation at a maternal and child health centre and reporting an infant sleep problem. The time horizon of the analysis was 12 months; costs included healthcare and informal care. The study included costs associated with consultations for sleep advice at maternal and child health centres, non-maternal and child health nurse professional healthcare (such as parenting centres and family doctor), non-professional care (such as books, care provided by relatives), intervention, and nurse training programme. The resource use estimates were based on the RCT (n=309) and the unit costs were obtained from local and national sources. The measure of outcome for the economic analysis was maternal report of infant sleep problem; presence of depression symptoms (measured using EPDS); and SF-12 mental health domain scores.
The intervention resulted in fewer mothers reporting an infant sleep problem: 39% and 55% in intervention and standard care groups, respectively (difference of -16%, p=0.004). The intervention also resulted in a reduction in EPDS scores: 5.9 and 7.2 in intervention and standard care groups, respectively (difference of -1.7 points, p=0.001); and improvement in SF-12 mental health domain scores: 49.7 and 46.1 in intervention and standard care groups, respectively (difference of 3.9 points, p <0.001). The costs in the study were measured in British pounds, expressed in 2007 prices. The mean cost per family over 12 months was £97 (SD £249) for the intervention and £117 (SD £330) for standard care, respectively, difference of -£19.44 (p=0.55). Results suggest that intervention provides better outcomes at a slightly lower cost, and thus is a dominant intervention.
The analysis was judged by the GDG to be partially applicable to this guideline review and the NICE reference case. This study was conducted in Australia where the healthcare system is sufficiently similar to the UK NHS. However, the analysis included cost categories beyond the NHS and PSS perspective (that is, costs associated with informal care). Also, the authors did not attempt to estimate QALYs but this did not affect interpretation of the results, since intervention was found to be dominant. Also, the source of unit costs was unclear. Overall, the study was judged by the GDG to have only minor methodological limitations.
Overall conclusions from existing economic evidence
The existing economic evidence on psychological and psychosocial interventions for the prevention of mental health problems in pregnancy or postnatal period is very limited. The systematic literature review identified two UK-based studies and two non-UK studies. None of the studies were directly applicable to the NICE decision-making context. Both UK-based studies found prevention interventions (home visiting and listening visits) to result in better outcomes however at an additional cost. This finding is supported by evidence from studies conducted in Chile where home visiting resulted in better outcomes but also led to an increase in costs. In an Australian study an infant sleep training intervention resulted in better outcomes at a slightly lower cost, and thus was found to be a dominant intervention. The results from these studies are not easy to interpret due to lack of use of QALYs as a measure of outcome in the majority of the studies, and difficulty in judging whether the additional cost per non-QALY outcomes such as a month in depression avoided, point improvement on a depression scale or point change on mother infant interaction scales represent good value for money. Overall, the results are inconclusive, as they do not use QALYs and it is difficult to judge whether the reported extra benefits associated with the prevention interventions are worth the extra costs associated with their provision.
7.5. PSYCHOLOGICAL AND PSYCHOSOCIAL INTERVENTIONS FOR THE TREATMENT OF MENTAL HEALTH PROBLEMS
7.5.1. Introduction
Despite the evidence illustrating that mental health problems are common, debilitating and have a broader direct effect on the woman's fetus and newborn infant, and that medication is less acceptable in pregnancy and the postnatal period than at other times, the efficacy and acceptability of psychological or psychosocial treatments in pregnancy and the postnatal period has not been extensively researched. Historically, there has been an emphasis on postnatal depression and most treatment research has been carried out in this field. Treatment in pregnancy and the period has been aimed at preventing the development of postnatal mental health problems, making such studies difficult to interpret.
There seem to be widely held but poorly substantiated beliefs that neither pregnancy nor the early postnatal period are times to make life changes and that psychological or psychosocial treatment may be harmful and should be avoided. This, in combination with the fact that being pregnant or having a newborn infant clearly leads to difficulties in accessing standard psychological treatments in general services that may have long waiting lists and inflexible clinic times, has exacerbated the problems of access to psychological treatments for this group. A number of attempts have been made to modify psychological treatments for pregnancy and the postnatal period, involving a broad range of healthcare professionals delivering treatments at home or in groups. Research comparing these modified treatments with standardised therapies such as CBT and IPT has not been undertaken and the advantage in the modification remains unclear.
7.5.2. Clinical review protocol (treatment)
The review protocol summary, including the review question(s) and the eligibility criteria used for this section of the guideline, can be found in Table 120. A complete list of review questions can be found in Appendix 8; further information about the search strategy can be found in Appendix 10; the full review protocols can be found in Appendix 9.
Table 120
Clinical review protocol summary for the review of psychological and psychosocial interventions for the treatment of mental health problems.
The review strategy was to evaluate the clinical effectiveness of the interventions using meta-analysis. However, in the absence of adequate data, the available evidence was synthesised using narrative methods. An analysis of all interventions was conducted and graded. Following this, sub-analysis was conducted (dependent on available data), based on baseline diagnostic status (clinical diagnosis [usually assessed using structured psychiatric interview]; symptoms [above a pre-specified threshold on a rating scale]; subthreshold symptoms [just below a pre-specified threshold on a rating scale]), treatment timing, mode of delivery, format (individual and/or group), and intensity. Where possible both an available case analysis and an intention-to-treat (ITT) analysis (WCS) were used.
7.5.3. Studies considered (treatment)
Seventy-four RCTs reported across 93 papers met the eligibility criteria for this review: AMMERMAN2013A/2013B, ARMSTRONG1999/2000/FRASER2000 (Armstrong et al., 1999; Armstrong et al., 2000; Fraser et al., 2000), ARMSTRONG2003 (Armstrong & Edwards, 2003), ARMSTRONG2004 (Armstrong & Edwards, 2004), AUSTIN2008 (Austin et al., 2008), BERNARD2011 (Bernard et al., 2011), BILSZTA2012 (Bilszta et al., 2012), BURNS2013/PEARSON2013B, CHEN2000 (Chen et al., 2000), CHO2008 (Cho et al., 2008), COOPER2003/MURRAY2003, DENNIS2003 (Dennis, 2003), DENNIS2009 (Dennis et al., 2009), DUGGAN2007/CALDERA2007 (Duggan et al., 2007; Caldera et al., 2007), DUGRAVIER2013/GUEDENEY2013 (Dugravier et al., 2013; Guedeney et al., 2013), ELMOHANDES2008 (El-Mohandes et al., 2008), FIELD2013A (Field et al., 2013a), GAMBLE2005 (Gamble et al., 2005), GAO2010/2012 (Gao et al., 2010; Gao et al., 2012), GUARDINO2014 (Guardino et al., 2014), GROTE2009, HAGAN2004 (Hagan et al., 2004), HAYDEN2012 (Hayden et al., 2012), HISCOCK2002, HISCOCK2007/2008 (Hiscock et al., 2007; Hiscock et al., 2008), HOLDEN1989 (Holden et al., 1989), HONEY2002 (Honey et al., 2002), HOROWITZ2001 (Horowitz et al., 2001), KAAYA2013 (Kaaya et al., 2013), KERSTING2011 (Kersting et al., 2011), KOZINSZKY2012 (Kozinszky et al., 2012), LE2011 (Le et al., 2011), LETOURNEAU2011 (Letourneau et al., 2011), LEUNG2012 (Leung & Lam, 2012), MILGROM2005B (Milgrom et al., 2005b), MILGROM2011A (Milgrom et al., 2011a), MILGROM2011B (Milgrom et al., 2011b), MISRI2000 (Misri et al., 2000), MORRELL2009A/2009B/2011/BRUGHA2011 (Morrell et al., 2009a; Morrell et al., 2009b; Morrell et al., 2011; Brugha et al., 2011), MULCAHY2010 (Mulcahy et al., 2010), MUNOZ2007/URIZAR2011 (Muñoz et al., 2007; Urizar & Muñoz, 2011), NEUGEBAUER2006 (Neugebauer et al., 2006), NIKCEVIC2007 (Nikčević et al., 2007), OHARA2000, OMAHEN2013A (O'Mahen et al., 2013a), OMAHEN2013B (O'Mahen et al., 2013b), OMAHEN2013C (O'Mahen et al., 2013c), ORTIZCOLLADO2014 (Ortiz-Collado et al., 2014), PINHEIRO2014 (Pinheiro et al., 2014), PRENDERGAST2001 (Prendergast & Austin, 2001), RAHMAN2008, ROMAN2009 (Roman et al., 2009), ROUHE2012/SALMELAARO2012 (Rouhe et al., 2012; Salmela-Aro et al., 2012); SAISTO2001 (Saisto et al., 2001), SALOMONSSON2011 (Salomonsson & Sandell, 2011), SILVERSTEIN2011 (Silverstein et al., 2011), SIMAVLI2014 (Simavli et al., 2014), SLEED2013 (Sleed et al., 2013), SPINELLI2003 (Spinelli & Endicott, 2003), STEIN2006 (Stein et al., 2006), SWANSON2009 (Swanson et al., 2009), TAMAKI2008 (Tamaki, 2008), TANDON2011/2014/MENDELSON2013 (Tandon et al., 2011; Tandon et al., 2014; Mendelson et al., 2013), TIMPANO2011 (Timpano et al., 2011), VANDOESUM2008/KERSTENALVAREZ2010 (van Doesum et al., 2008; Kersten-Alvarez et al., 2010), VIETEN2008 (Vieten & Astin, 2008), WEIDNER2010 (Weidner et al., 2010), WICKBERG1996 (Wickberg & Hwang, 1996), WIGGINS2005 (Wiggins et al., 2005), WIKLUND2010 (Wiklund et al., 2010), ZELKOWITZ2008/2011/FEELEY2012 (Zelkowitz et al., 2008; Zelkowitz et al., 2011; Feeley et al., 2012), ZLOTNICK2001 (Zlotnick et al., 2001), ZLOTNICK2006 (Zlotnick et al., 2006), ZLOTNICK2011 (Zlotnick et al., 2011). All of these studies were published in peer-reviewed journals between 1989 and 2014. In addition, 20 studies were excluded from the review. The most common reasons for exclusion were that data could not be extracted, the intervention was outside the scope (organisation of care), non-randomised group allocation, or the paper did not report mental health outcomes. Further information about both included and excluded studies can be found in Appendix 18.
Of the 74 included RCTs, there were 14 studies (N=2,099) involving a comparison of structured psychological interventions (CBT or IPT) and treatment as usual or enhanced treatment as usual, two studies (N=438) compared CBT to listening visits, one study (N=60) compared CBT and relational constructivist therapy, and one study (N=48) involved a comparison of IPT and a support group (Table 121).
Table 121
Study information table for trials included in the meta-analysis of structured psychological interventions (CBT or IPT) versus any alternative management strategy.
Three RCTs (N=1,136) involved a comparison of facilitated self-help and treatment as usual, and two studies involved a comparison of post-miscarriage self-help and treatment as usual (N=255), one study compared post-miscarriage facilitated self-help with treatment as usual (N=171; Table 122).
Table 122
Study information table for trials included in the meta-analysis of self-help or facilitated self-help versus any alternative management strategy.
Five studies (N=1,018) compared listening visits (non-directive counselling) and treatment as usual, one study (N=146) involved a comparison of directive counselling and treatment as usual, three studies (N=269) compared post-miscarriage counselling and treatment as usual or enhanced treatment as usual, and one study (N=103) compared post-traumatic birth counselling and treatment as usual (Table 123).
Table 123
Study information table for trials included in the meta-analysis of counselling versus any alternative management strategy.
Four studies (N=867) involved a comparison of social support (peer-mediated support or support group) and treatment as usual, 16 studies (N=2,955) compared psychologically (CBT/IPT)-informed psychoeducation and treatment as usual or enhanced treatment as usual, one study (N=38) involved a comparison between IPT-informed psychoeducation and a non-mental health-focused education and support group, one study (N=331) compared non-mental health-focused education and support (group counselling intervention for HIV-positive women) and treatment as usual, five studies (N=1,616) compared home visits with treatment as usual or enhanced treatment as usual, and two studies (N=547) compared pre-delivery discussion/psychoeducation for tokophobia and treatment as usual (Table 124). Six studies (N=691) compared mother–infant relationship interventions and treatment as usual, one study (N=51) involved a comparison of mother–infant relationship intervention with video feedback and mother–infant relationship intervention with verbal feedback (this trial also included a TAU arm but this data could not be extracted due to non-random assignment to that condition), one study (N=80) compared mother–infant relationship intervention and listening visits (participants in both conditions also received facilitated self-help aimed at their eating disorder), and one study (N=29) compared a co-parenting intervention and enhanced treatment as usual (Table 125).
Table 124
Study information table for trials included in the meta-analysis of education or support versus any alternative management strategy.
Table 125
Study information table for trials included in the meta-analysis of mother–infant relationship interventions versus any alternative management strategy.
Two studies (N=394) involved a comparison of infant sleep training (controlled crying) and treatment as usual or enhanced treatment as usual, one study (N=161) compared music therapy during birth and treatment as usual, two studies (N=276) compared a psychosomatic intervention and treatment as usual, and two studies (N=81) compared mindfulness training and treatment as usual or enhanced treatment as usual (Table 126).
Table 126
Study information table for trials included in the meta-analysis of other psychosocial interventions versus any alternative management strategy.
Finally, there was one study (N=20) that compared a combined psychosocial (informal support group) and physical (exercise) with enhanced treatment as usual, and one study (N=24) that involved a comparison of social support and physical exercise (Table 127).
Table 127
Study information table for trials included in the meta-analysis of combined psychosocial and physical interventions.
For the review of psychosocial treatment for alcohol or substance misuse, three Cochrane reviews met the eligibility criteria for this review: STADE2009B (Stade et al., 2009b), TERPLAN2007 (Terplan & Liu, 2007), TURNBULL2012 (Turnball & Osborn, 2012). In addition, five individual studies (MARAIS2011 [Marais et al., 2011], OSTERMAN2012 [Osterman & Dyehouse, 2012], OSTERMAN2014 [Osterman et al., 2014], WINHUSEN2008 [Winhusen et al., 2008], YONKERS2012 [Yonkers et al., 2012] met the eligibility criteria for this review and were used to update the Cochrane reviews. An additional three primary RCTs (FLEMING2008 [Fleming et al., 2008], ONDERSMA2014 [Ondersma et al., 2014], SILVERMAN2002 [Silverman et al., 2002]) met eligibility criteria for this review but not for any of the Cochrane reviews and were analysed separately (Table 128). An additional Cochrane review was identified by the search, however, no suitable trials were identified by this review and as a result there was no data that could be extracted (LUI2008 [Lui et al., 2008]). A further seven studies were identified by the search for this review (and were not reviewed in any of the Cochrane reviews) but were excluded on the following basis: systematic review with no new data (Gilinsky et al., 2011); no mental health outcome reported (Armstrong et al., 2009); data could not be extracted (Kropp et al., 2010; Ondersma et al., 2012); intervention was delivered greater than 1 year into the postnatal period (Suchman et al., 2010; Suchman et al., 2011; Suchman et al., 2012).
Table 128
Study information table for systematic reviews and primary RCTs included in the review of psychosocial interventions for alcohol and substance misuse.
7.5.4. Clinical evidence for effects on depression outcomes (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Depression: structured psychological interventions (CBT or IPT) versus treatment as usual or enhanced treatment as usual
Very low to high quality evidence from up to ten studies (N=1,508) showed that structured psychological interventions (CBT or IPT) were more effective than treatment as usual or enhanced treatment as usual (using both ITT and available case analysis) in reducing depression diagnosis (p <0.0001), depression symptomatology (p ≤0.0004) and depression mean scores (p <0.00001) at post-treatment, with large to moderate effects observed for all outcomes and some low quality evidence for maintained moderate to large effects at short-term follow-up (9-16 weeks post-intervention; p <0.01) (Table 129). At intermediate follow-up periods (17-24 weeks post-intervention) there was evidence for moderate benefits associated with structured psychological interventions, however, confidence that these were true measures of effect was low to very low due to wide confidence intervals including the possibility of both no effect and clinically significant benefits for depression diagnosis (available case analysis) and depression mean scores (p=0.08-0.41) and in the case of the ITT analysis of depression diagnosis the 95% CI spans the thresholds for harm, no effect and benefit (p=0.23). At longer-term follow-ups (>24 weeks post-intervention), the evidence for structured psychological interventions is very inconsistent with point estimates of effect in favour of CBT or IPT for depression symptomatology (p=0.41-0.59), but in favour of treatment as usual or enhanced treatment as usual for depression diagnosis (p=0.02-0.25) (Table 129).
Table 129
Summary of findings table for effects of structured psychological interventions (CBT or IPT) compared with treatment as usual or enhanced treatment as usual on depression outcomes.
Depression: structured psychological interventions (CBT or IPT) versus alternative active intervention
There was no evidence for benefits associated with CBT relative to listening visits on mean depression symptoms at endpoint or first measurement (p=0.69; Table 130).
Table 130
Summary of findings table for effects of CBT compared with listening visits on depression outcomes.
There was very low quality, single study (N=60) evidence for moderate benefits (p=0.04) associated with relational constructivist therapy over CBT on mean depression symptoms (Table 131).
Table 131
Summary of findings table for effects of CBT compared with relational constructivist therapy on depression outcomes.
There was no evidence for clinically or statistically significant effects of IPT relative to a support group on mean depression symptoms (p=0.11; Table 132).
Table 132
Summary of findings table for effects of IPT compared with support group on depression outcomes.
Depression: facilitated self-help versus treatment as usual
There was very low to high quality data from up to three studies (N=1,136) for moderate benefits (p <0.00001 to p=0.04) of facilitated self-help relative to treatment as usual for depression symptomatology (ITT and available case analysis) and mean depression symptoms (Table 133).
Table 133
Summary of findings table for effects of facilitated self-help compared with treatment as usual on depression outcomes.
Depression: post-miscarriage self-help or facilitated self-help versus treatment as usual
There was low quality, single study (N=78) evidence that post-miscarriage self-help was more effective than treatment as usual for depression symptomatology (analysed according to ITT [p=0.02] or available case [p=0.005] approaches) with moderate to large effects observed. However, the measure for depression symptomatology was treatment non-response (based on reverse scale rating of reliable change index) on the BSI Depression subscale rather than a depression-specific validated checklist. In addition, there was some discrepancy between dichotomous and continuous measures of depression. There was no evidence for clinically or statistically significant benefits (p=0.32-0.51) of post-miscarriage self-help or facilitated self-help on mean depression symptoms (Table 134 and Table 135).
Table 134
Summary of findings table for effects of post-miscarriage self-help compared with treatment as usual on depression outcomes.
Table 135
Summary of findings table for effects of post-miscarriage facilitated self-help compared with treatment as usual on depression outcomes.
Depression: listening visits versus treatment as usual
When an available case method of analysis was adopted there was very low quality evidence from three studies (N=179) for moderate benefits (p=0.03) of listening visits on depression diagnosis (Table 136). However, there was no evidence for statistically significant benefits of listening visits for depression diagnosis using an ITT data analysis approach (p=0.12) or for statistically or clinically significant effects of listening visits on depression symptomatology using an ITT or available case analysis approach (p=0.07-0.50), or for clinically significant effects on mean depression symptoms (p=0.001). In addition, at intermediate follow-up periods (17-24 weeks post-intervention) there was no evidence for statistically or clinically significant benefits on depression diagnosis using either data analysis method (p=0.62-0.91) or on depression mean symptoms (p=0.73). Moreover, at longer-term follow-ups the evidence for treatment effects is very inconsistent with no evidence for clinically or statistically significant benefits or harms of listening visits compared with treatment as usual on depression diagnosis at >104 week follow-up using an available case analysis (p=0.76) or depression symptomatology at 25-103 week follow-up (p=0.65-0.77) or mean depression symptoms at 25-103 week or >104 week follow-ups (p=0.45-0.49), but with point estimates suggestive of clinically significant harms(effects in favour of treatment as usual) on depression diagnosis at 25-103 week follow-up (p=0.18-0.26) and at >104 week follow-up (p=0.03).
Table 136
Summary of findings table for effects of listening visits compared with treatment as usual on depression outcomes.
Depression: directive counselling versus treatment as usual
There was low quality, single study (N=146) evidence that directive counselling was more effective than treatment as usual for depression symptomatology (using either ITT or available case methods of analysis) with moderate effects observed on dichotomous measures at endpoint (p=0.002-0.003) and a large effect observed on a continuous measure at long-term follow-up (p=0.0005), although it is important to note that the effects on mean depression symptoms at endpoint (p=0.11) were not statistically or clinically significant (Table 137).
Table 137
Summary of findings table for effects of directive counselling compared with treatment as usual on depression outcomes.
Depression: post-miscarriage counselling versus treatment as usual or enhanced treatment as usual
There was no evidence for clinically or statistically significant benefits associated with post-miscarriage counselling on mean depression symptoms at endpoint (ITT [p=0.24] or available case [p=0.52] analysis) or at intermediate (p=0.36) or long (p=0.62) follow-ups (Table 138).
Table 138
Summary of findings table for effects of post-miscarriage counselling compared with treatment as usual on depression outcomes.
Depression: post-traumatic birth counselling versus treatment as usual
There was low quality, single study (N=103) evidence for large effects (p=0.008) of post-traumatic birth counselling on depression symptomatology (Table 139).
Table 139
Summary of findings table for effects of post-traumatic birth counselling compared with treatment as usual on depression outcomes.
Depression: social support versus treatment as usual
There were mixed results for treatment effects on depression outcomes associated with peer-mediated support or support groups (mutual support). There was low to moderate quality evidence from three studies (N=713/807) for moderate benefits of social support on depression symptomatology at endpoint using an ITT (p=0.05) or available case (p <0.0001) data analysis approach (Table 140). However, these effects appeared to be transient as no clinically or statistically significant benefits (p=0.38-0.40) were observed on depression symptomatology at short-term follow-up (9-16 weeks post-intervention). Moreover, there was no evidence for clinically or statistically significant benefits of social support on depression diagnosis at endpoint using ITT analysis (p=0.52) or for mean depression symptoms at endpoint (p=0.68) or short-term follow-up (p=0.11) and no statistically significant treatment effects on depression diagnosis at endpoint using an available case analysis approach (p=0.18).
Table 140
Summary of findings table for effects of social support compared with treatment as usual on depression outcomes.
Depression: Psychologically (CBT/IPT)-informed psychoeducation versus treatment as usual or enhanced treatment as usual
There was inconsistent evidence for benefits associated with psychologically-informed psychoeducation. There was evidence from up to eight studies (N=985) for moderate effects of psychoeducation on depression diagnosis at endpoint using an ITT or available case data analysis approach (p=0.10) and at long-term follow-up (25-103 weeks post-intervention) using an available case analysis approach (p=0.06), however, the confidence in these effect estimates is very low due to the 95% CI including both estimates of no effect and estimates of appreciable clinical benefit (Table 141). There was also high quality evidence from five studies (N=1,518) for small to moderate (statistically significant) benefits associated with psychoeducation observed on depression symptomatology (ITT [p=0.0008] and available case [p=0.03] analysis), however, here it is unclear that benefits were clinically meaningful with the treatment effect in the available case analysis falling below the threshold for clinically meaningful benefit. Treatment effects of psychoeducation on mean depression scores at endpoint (although in many cases statistically significant) also failed to reach the threshold for clinically significant benefits at endpoint (using either ITT [p=0.13] or available case [p=0.01] analysis approaches) or at short-term (9-16 week post-intervention) follow-up (with ITT [p=0.005] or available case [p=0.04] analysis) or long-term follow-up (with ITT [p=0.05] or available case [p=0.006] analysis). There was also no evidence for any statistically or clinically significant treatment effects for any outcome measures at intermediate (17-24 weeks post-intervention) follow-up (p=0.38-0.78) or for depression diagnosis at long-term follow-up using an ITT analysis approach (p=0.20).
Table 141
Summary of findings table for effects of psychologically (CBT/IPT)-informed psychoeducation compared with treatment as usual or enhanced treatment as usual on depression outcomes.
Depression: Psychologically (CBT/IPT)-informed psychoeducation versus alternative active intervention
There was no evidence that IPT-informed psychoeduation was more effective than non-mental health-focused education and support for treating depression symptomatology (p=0.12; Table 142).
Table 142
Summary of findings table for effects of IPT-informed psychoeducation compared with non-mental health-focused education and support on depression outcomes.
Depression: non-mental health-focused education and support versus treatment as usual
There was no evidence for clinically or statistically significant benefits (p=0.07) associated with non-mental health-focused education and support for depression symptomatology (Table 143).
Table 143
Summary of findings table for effects of non-mental health-focused education and support compared with treatment as usual on depression outcomes.
Depression: home visits versus treatment as usual or enhanced treatment as usual
There was single study (N=16-18) evidence for large (available case analysis [p=0.19]) to moderate (ITT analysis [p=0.36]) benefits of home visits on depression diagnosis (Table 144). However, confidence in these effect estimates is very low due to the 95% CI including estimates of both no effect and clinically meaningful treatment benefits. Moreover, there was no evidence of clinically or statistically significant treatment effects on depression symptomology (p=0.23-0.24), or clinically significant treatment effects on mean depression symptoms (p=0.008).
Table 144
Summary of findings table for effects of home visits compared with treatment as usual or enhanced treatment as usual on depression outcomes.
Depression: mother-infant relationship interventions versus treatment as usual or enhanced treatment as usual
Evidence for treatment effects of mother–infant relationship interventions on depression outcome measures was very inconsistent (Table 145). There was single study (N=92-95) evidence for moderate benefits of a mother–infant relationship intervention on depression diagnosis at endpoint (p=0.10-0.11) and very long-term follow-up (>103 weeks post-intervention) using available case analysis (p=0.42). However, the quality of this evidence was low due to very serious imprecision (with small number of events and 95% CIs including estimates of no effect and clinically meaningful benefit). Conversely, there was single study evidence suggestive of harms associated with mother–infant relationship interventions on depression symptomatology at intermediate (17-24 weeks post-intervention) follow-up (p=0.40-0.42) and depression diagnosis at long-term follow-up (25-103 weeks post-intervention) using available case analysis (p=0.28). However, again the quality of the evidence is low due to very serious imprecision. In addition, low quality evidence from meta-analyses with up to six studies (N=566) provided no evidence for clinically or statistically significant benefits of mother–infant relationship interventions on depression symptomatology at endpoint (p=0.25-0.41), or depression mean symptoms at endpoint (p=0.93) or long-term follow-up (p=0.61). Single study data for depression diagnosis and depression mean symptoms at intermediate follow-up, depression diagnosis at long-term follow-up (using ITT analysis) or very long-term follow-up (using ITT analysis), and depression mean symptoms at very long-term follow-up also provided no evidence for clinically or statistically significant treatment effects (p=0.49-0.62).
Table 145
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual or enhanced treatment as usual on depression outcomes.
A single study also examined differences between two active intervention arms and found no advantage to video feedback compared with verbal feedback (p=0.38) for effects of mother–infant relationship interventions on mean depression symptoms (Table 146).
Table 146
Summary of findings table for effects of mother-infant relationship intervention with video feedback compared with mother-infant relationship intervention with verbal feedback on depression outcomes.
Depression: co-parenting intervention versus enhanced treatment as usual
There was single study (N=29) evidence for a moderate effect of a co-parenting intervention on depression diagnosis (p=0.12). However, confidence in this effect estimate was very low due to very serious imprecision (small number of events and a large 95% CI encompassing no effects and appreciable benefits). In addition, the same study showed no evidence for statistically or clinically significant benefits of a co-parenting intervention on mean depression symptoms (p=0.23; Table 147).
Table 147
Summary of findings table for effects of co-parenting intervention compared with enhanced treatment as usual on depression outcomes.
Depression: infant sleep training (controlled crying) versus treatment as usual or enhanced treatment as usual
There was low quality single study (N=272) evidence for moderate effects of infant sleep training (controlled crying) on maternal depression symptomatology (p=0.03). There was also low to moderate quality evidence from up to two studies (N=184-272) for statistically significant benefits of controlled crying on mean depression symptoms at endpoint or first measurement, short-term follow-up, and long-term follow-up (p=0.03-0.001), however, these effects were small and below the threshold for appreciable clinical benefit (Table 148).
Table 148
Summary of findings table for effects of infant sleep training (controlled crying) compared with treatment as usual or enhanced treatment as usual on depression outcomes.
Depression: music therapy during birth versus treatment as usual
There was low quality, single study (N=141) evidence for large effects of music therapy during birth on depression symptomatology using available case analysis (p=0.04), moderate effects on depression symptomatology using ITT analysis (p=0.07) and small effects on mean depression symptoms immediately post-birth (p=0.03). However, there was serious imprecision across all outcome measures due to the low number of events or small sample size and/or large 95% CIs encompassing estimates of no effect and appreciable benefit (Table 149).
Table 149
Summary of findings table for effects of music therapy during birth compared with treatment as usual on depression outcomes.
Depression: Psychosomatic interventions versus treatment as usual
There was no evidence that psychosomatic interventions conferred appreciable and clinically meaningful benefits on depression symptomatology (p=0.04-0.18) or mean depression symptoms (p=0.22; Table 150).
Table 150
Summary of findings table for effects of psychosomatic intervention compared with treatment as usual on depression outcomes.
Depression: mindfulness training versus treatment as usual or enhanced treatment as usual
There was no evidence for statistically or clinically significant benefits associated with mindfulness training on depression mean symptoms (p=0.72) or negative affect mean scores (p=0.38; Table 151).
Table 151
Summary of findings table for effects of mindfulness training compared with treatment as usual or enhanced treatment as usual on depression outcomes.
Depression: combined social support and physical exercise versus enhanced treatment as usual
There was single study (N=20) evidence for large benefits of a combined informal social support group and pram walking exercise programme on depression symptomatology (p=0.05) and mean depression symptoms (p=0.002). However, confidence in these effect estimates is low due to the extremely low event rate and very small sample size, and in the case of the depression symptomatology outcome measure the 95% CI includes both no effect and appreciable benefit (Table 152).
Table 152
Summary of findings table for effects of combined social support and physical exercise compared with enhanced treatment as usual on depression outcomes.
Depression: social support versus physical exercise
In order to tease apart the combined psychosocial and physical intervention effect (discussed above), the same researchers compared social support and physical exercise in a head-to-head trial and provided single study (N=20) evidence for a large effect of social support (social support group) relative to physical exercise (pram walking exercise programme) on depression mean symptoms (p=0.03). However, confidence in this effect estimate was low due to imprecision as a result of the very small sample size (Table 153).
Table 153
Summary of findings table for effects of social support compared with physical exercise on depression outcomes.
7.5.5. Clinical evidence for effects on anxiety outcomes (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Anxiety: structured psychological interventions (CBT or IPT) versus treatment as usual or enhanced treatment as usual
There was low quality, single study (N=53) evidence for a large effect of a structured psychological intervention on mean state anxiety symptoms (using an ITT analysis approach [p <0.0001]). However, the only meta-analysis possible (two studies, N=315) revealed no evidence for clinically significant benefits (although differences were statistically significant) associated with mean state anxiety symptoms (p=0.002), and the small benefit for trait anxiety symptoms found in a single study analysis also failed to reach the threshold for appreciable benefit despite meeting statistical significance criteria (p=0.002; Table 154).
Table 154
Summary of findings table for effects of structured psychological interventions (CBT or IPT) compared with treatment as usual or enhanced treatment as usual on anxiety outcomes.
Anxiety: structured psychological interventions (CBT or IPT) versus alternative active intervention
There was no evidence for a clinically or statistically significant benefit of CBT relative to RCT on mean anxiety symptoms (p=0.31; Table 155).
Table 155
Summary of findings table for effects of CBT compared with relational constructivist therapy on anxiety outcomes.
There was no evidence for a clinically or statistically significant benefit associated with IPT relative to a support group for treating mean anxiety symptoms (p=0.11; Table 156).
Table 156
Summary of findings table for effects of IPT compared with support group on anxiety outcomes.
Anxiety: facilitated self-help versus treatment as usual
There was very low quality, single study (N=59-143) evidence (using both available case and ITT data analysis methods) for moderate to large benefits of facilitated self-help relative to treatment as usual for treating anxiety symptomatology (p=0.02-0.03) and for mean anxiety symptoms (p=0.06; Table 157).
Table 157
Summary of findings table for effects of facilitated self-help compared with treatment as usual on anxiety outcomes.
Anxiety: post-miscarriage self-help versus treatment as usual
There was no evidence for statistically or clinically significant benefits of post-miscarriage self-help on anxiety symptomatology (p=0.35-0.71) or mean symptoms (p=0.33; Table 158).
Table 158
Summary of findings table for effects of post-miscarriage self-help compared with treatment as usual on anxiety outcomes.
Anxiety: listening visits versus treatment as usual
There was low quality single study (N=254-260) evidence for statistically significant effects of listening visits on mean state (p=0.02) and trait (p=0.04) anxiety symptoms (Table 159). However, these effects were small and failed to reach a threshold indicative of clinically significant treatment benefits. In addition, the confidence in the effect estimates was low due to small sample size and selective outcome reporting.
Table 159
Summary of findings table for effects of listening visits compared with treatment as usual on anxiety outcomes.
Anxiety: directive counselling versus treatment as usual
There was low quality single study (N=90) evidence for moderate effects of directive counselling on mean anxiety symptoms (p=0.04) using an available case analysis approach (Table 160).
Table 160
Summary of findings table for effects of directive counselling compared with treatment as usual on anxiety outcomes.
Anxiety: post-miscarriage counselling versus treatment as usual or enhanced treatment as usual
There was no evidence for statistically or clinically significant benefits of post-miscarriage counselling on anxiety mean scores at endpoint (p=0.67) or at intermediate follow-up (p=0.21; Table 161).
Table 161
Summary of findings table for effects of post-miscarriage counselling compared with treatment as usual on anxiety outcomes.
Anxiety: post-traumatic birth counselling versus treatment as usual
There was single study (N=103) evidence for a large effect of post-traumatic birth counselling on anxiety symptomatology (p=0.10). However, confidence that this is a true measure of the effect is low due to the low number of events and the fact that the 95% CI crosses both the line of no effect and the measure of appreciable benefit (Table 162).
Table 162
Summary of findings table for effects of post-traumatic birth counselling compared with treatment as usual on anxiety outcomes.
Anxiety: social support versus treatment as usual
There was no evidence for clinically or statistically significant benefits of social support on anxiety symptomatology (p=0.05-0.47) or anxiety mean symptoms (p=0.08-0.42; Table 163).
Table 163
Summary of findings table for effects of social support compared with treatment as usual on anxiety outcomes.
Anxiety: psychologically (CBT/IPT)-informed psychoeducation versus treatment as usual or enhanced treatment as usual
There was no evidence for statistically or clinically significant benefits of psychologically-informed psychoeducation for anxiety diagnosis at endpoint (p=0.58-0.89) or at long-term follow-up (p=0.99; Table 164).
Table 164
Summary of findings table for effects of psychologically (CBT/IPT)-informed psychoeducation compared with treatment as usual or enhanced treatment as usual on anxiety outcomes.
Anxiety: mother-infant relationship interventions versus treatment as usual or enhanced treatment as usual
There was low quality single study (N=98) evidence for a large effect of a mother–infant relationship intervention on anxiety symptomatology using an available case analysis (p=0.31). However, the imprecision of this effect estimate was very serious due to the small number of events and large 95% CI. In addition, when an ITT analysis approach was adopted there was no evidence for clinically or statistically significant benefits on anxiety symptomatology (p=0.86), or mean anxiety symptoms using an available case analysis at endpoint (p=0.44) or intermediate follow-up (p=0.15; Table 165).
Table 165
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual or enhanced treatment as usual on anxiety outcomes.
Anxiety: music therapy during birth versus treatment as usual
There was low quality single study (N=141) evidence for a statistically significant large effect of music therapy during birth on anxiety mean symptoms immediately post-birth using an available case analysis approach (p <0.00001; Table 166). However, unfortunately, ITT (WCS) data cannot be extracted or computed for this outcome and meta-analysis was not possible. Moreover, the clinical significance and generalisability of effects on immediate post-birth anxiety to longer-term anxiety symptoms is unclear.
Table 166
Summary of findings table for effects of music therapy compared with treatment as usual on anxiety outcomes.
Anxiety: psychosomatic intervention versus treatment as usual
There was no evidence for a statistically or clinically significant effect of a psychosomatic intervention on mean anxiety symptoms (p=0.57; Table 167).
Table 167
Summary of findings table for effects of psychosomatic intervention compared with treatment as usual on anxiety outcomes.
Anxiety: mindfulness training versus treatment as usual or enhanced treatment as usual
There was no evidence for statistically or clinically significant effects of mindfulness training on mean anxiety symptoms using either an ITT analysis (p=0.44) or available case analysis (p=0.95; Table 168).
Table 168
Summary of findings table for effects of mindfulness training compared with treatment as usual or enhanced treatment as usual on anxiety outcomes.
7.5.6. Clinical evidence for effects on adjustment disorder outcomes (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Adjustment disorder: psychologically (CBT/IPT)-informed psychoeducation versus treatment as usual or enhanced treatment as usual
There was no evidence for a clinically or statistically significant effect of psychologically-informed psychoeducation on adjustment disorder diagnosis (p=0.77; Table 169).
Table 169
Summary of findings table for effects of psychologically (CBT/IPT)-informed psychoeducation compared with treatment as usual or enhanced treatment as usual on adjustment disorder outcomes.
7.5.7. Clinical evidence for effects on PTSD outcomes (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
PTSD: post-miscarriage self-help versus treatment as usual
There was low quality, single study (N=78) evidence for moderate to large effects of post-miscarriage self-help on PTSD symptomatology (analysed using ITT [p=0.02] or available case [p=0.004] approaches) and large effects on mean PTSD symptoms (p=0.0004; Table 170).
Table 170
Summary of findings table for effects of post-miscarriage self-help compared with treatment as usual on PTSD outcomes.
PTSD: post-traumatic birth counselling versus treatment as usual
There was no evidence for statistically or clinically significant benefits of post-traumatic birth counselling on PTSD diagnosis (p=0.10) and no evidence for a clinically significant effect (despite meeting statistical significance criteria as p=0.04) on mean PTSD symptoms (Table 171).
Table 171
Summary of findings table for effects of post-traumatic counselling compared with treatment as usual on PTSD outcomes.
PTSD: psychologically (CBT/IPT)-informed psychoeducation versus treatment as usual or enhanced treatment as usual
There was inconsistent evidence for benefits associated with psychoeducation for PTSD outcomes, with the ITT analysis of PTSD symptomatology suggestive of moderate benefits of psychoeducation (p=0.63), the available case analysis suggestive of large harms associated with psychoeducation for PTSD symptomatology (p=0.56), and two studies (N=96) providing evidence for small benefits of psychoeducation on continuous measures of PTSD symptoms (p=0.05). However, there was no evidence for statistically significant benefits for any of the outcome measures and the very low quality of evidence due to risk of bias concerns (unclear blinding of outcome assessment), very serious imprecision (due to small event rates/sample size and large 95% CIs) and selective outcome reporting prohibits any clear conclusions being drawn from this evidence (Table 172).
Table 172
Summary of findings table for effects of psychologically (CBT/IPT)-informed psychoeducation compared with treatment as usual on PTSD outcomes.
PTSD: mother-infant relationship interventions versus treatment as usual or enhanced treatment as usual
There was no evidence for clinically or statistically significant benefits or harms associated with mother–infant relationship interventions for PTSD symptomatology at endpoint when an ITT analysis approach was adopted (p=0.52) or at intermediate follow-up using either data analysis method (p=0.57-0.95) or for PTSD mean symptoms at endpoint (p=0.61) or intermediate follow-up (p=0.21). There was low quality single study (N=98) evidence for moderate harms associated with a mother–infant relationship intervention on PTSD symptomatology when an available case analysis was used (p=0.54). However, very serious imprecision of this effect estimate prohibits any clear conclusions being drawn from this data (Table 173).
Table 173
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual on PTSD outcomes.
7.5.8. Clinical evidence for effects on OCD outcomes (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
OCD: psychologically (CBT/IPT)-informed psychoeducation versus treatment as usual or enhanced treatment as usual
There was very low quality single study (N=58) evidence for delayed but statistically significant moderate to large effects of psychoeducation on mean OCD symptoms at intermediate and long-term follow-ups (total scores [p=0.01-0.02] and obsessions [p=0.02-0.03] and compulsions [p=0.02] subscales), with statistically and clinically non-significant effects at endpoint (p=0.12-0.24; Table 174).
Table 174
Summary of findings table for effects of psychologically (CBT/IPT)-informed psychoeducation interventions compared with treatment as usual or enhanced treatment as usual on OCD outcomes.
7.5.9. Clinical evidence for effects on fear of childbirth outcomes (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Fear of childbirth: pre-delivery discussion/psychoeducation versus treatment as usual
There was no evidence for clinically or statistically significant benefits of pre-delivery discussion/psychoeducation on mode of delivery (elective caesarean [p=0.76]; choosing vaginal delivery [p=0.69]; vaginal delivery [p=0.21]) or for pre-delivery fear of, or preparedness for, childbirth (p=0.13-0.53) or satisfaction with childbirth (p=0.14). There was moderate to very low quality, single study (N=176-371) evidence for small but statistically significant effects on continuous measures of feeling safe during childbirth (p=0.01), experience of fear during childbirth (p=0.001), and maternal attitude to motherhood (p=0.02). However, these benefits were not appreciable and may not be clinically meaningful (Table 175).
Table 175
Summary of findings table for effects of pre-delivery discussion/psychoeducation compared with treatment as usual on fear of childbirth outcomes.
7.5.10. Clinical evidence for effects on eating disorder outcomes (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Eating disorders: mother-infant relationship interventions (and facilitated self-help) versus listening visits (and facilitated self-help)
There was no evidence for statistically or clinically significant benefits of mother–infant relationship interventions compared with listening visits on eating disorder diagnosis (p=0.81-0.92; Table 176). However, it is important to note that participants in both active intervention arms received facilitated self-help aimed at their eating disorder.
Table 176
Summary of findings table for effects of mother–infant relationship intervention (and facilitated self-help) compared with listening visits (and facilitated self-help) on eating disorder outcomes.
7.5.11. Clinical evidence for effects on general mental health outcomes (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
General mental health outcomes: structured psychological interventions (CBT or IPT) versus treatment as usual or enhanced treatment as usual
There was low to very low quality evidence from up to two studies (N=305) for moderate to large benefits of structured psychological interventions (CBT or IPT) on general mental health outcomes at endpoint (p=0.0004-0.08), and at short-term (p=0.0007) and intermediate (p=0.06) follow-ups. There was also evidence for a statistically significant, but not clinically significant, effect of CBT on reducing the risk of self-harm (p=0.009) (Table 177).
Table 177
Summary of findings table for effects of structured psychological interventions (CBT or IPT) compared with treatment as usual or enhanced treatment as usual on general mental health outcomes.
General mental health outcomes: IPT versus support group
There was no evidence for clinically or statistically significant benefits of IPT relative to a support group on anger mean scores (p=0.77; Table 178).
Table 178
Summary of findings table for effects of IPT compared with support group on general mental health outcomes.
General mental health outcomes: post-miscarriage self-help versus treatment as usual
There was single study (N=78) evidence for moderate to large effects of post-miscarriage self-help on global mental health severity (treatment non-response [p=0.02-0.06] and mean scores [p=0.005]) (Table 179).
Table 179
Summary of findings table for effects of post-miscarriage self-help compared with treatment as usual on general mental health outcomes.
General mental health outcomes: listening visits versus treatment as usual
There was single study (N=271-276) evidence for small benefits of listening visits on general mental health (p=0.0006) and risk of self-harm (p=0.01) mean scores (Table 180). However, these effects are too small to meet criteria for appreciable benefits and are unlikely to be clinically meaningful.
Table 180
Summary of findings table for effects of listening visits compared with treatment as usual on general mental health outcomes.
General mental health outcomes: post-miscarriage counselling versus treatment as usual
There was no evidence for clinically or statistically significant effects of post-miscarriage counselling on feelings of self-blame at post-treatment (p=0.55) or intermediate follow-up (p=0.91) (Table 181).
Table 181
Summary of findings table for effects of post-miscarriage counselling compared with treatment as usual on general mental health outcomes.
General mental health outcomes: post-traumatic birth counselling versus treatment as usual
There was low quality, single study (N=103) evidence for large harms associated with post-traumatic birth counselling (p <0.00001) with mean scores on a study-specific measure of feelings of self-blame favouring treatment as usual (Table 182).
Table 182
Summary of findings table for effects of post-traumatic birth counselling compared with treatment as usual on general mental health outcomes.
General mental health outcomes: psychologically (CBT/IPT)-informed psychoeducation versus treatment as usual or enhanced treatment as usual
There was no evidence for clinically significant benefits (or harms) of psychoeducation on diagnosis of any psychopathology (p=0.90) or on general mental health mean scores at post-treatment (p=0.001) or short-term follow-up (p=0.27) (Table 183).
Table 183
Summary of findings table for effects of psychologically (CBT/IPT)-informed psychoeducation compared with treatment as usual or enhanced treatment as usual on general mental health outcomes.
General mental health outcomes: home visits versus treatment as usual or enhanced treatment as usual
There was no evidence of clinically or statistically significant benefits of home visits on general mental health symptomatology (p=0.47-0.79) or on alcohol or drug use (p=0.22-0.34) (Table 184).
Table 184
Summary of findings table for effects of home visits compared with treatment as usual or enhanced treatment as usual on general mental health outcomes.
General mental health outcomes: mother-infant relationship interventions versus treatment as usual or enhanced treatment as usual
There was no evidence for clinically or statistically significant effects of mother–infant relationship interventions on general mental health treatment non-response (p=0.42-0.50) or global severity mean scores (p=0.29) (Table 185).
Table 185
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual or enhanced treatment as usual on general mental health outcomes.
General mental health outcomes: co-parenting intervention versus enhanced treatment as usual
There was single study (N=28) evidence for a moderate benefit of a co-parenting intervention on reducing psychological distress (p=0.09). However, confidence in this effect estimate is low due to very serious imprecision as a result of the very small sample size and the 95% CI includes both no effect and appreciable benefit (Table 186).
Table 186
Summary of findings table for effects of co-parenting intervention compared with enhanced treatment as usual on general mental health outcomes.
7.5.12. Clinical evidence for effects on mother–infant attachment (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Mother-infant attachment: structured psychological interventions (CBT or IPT) versus treatment as usual or enhanced treatment as usual
There was high to very low quality evidence from up to two studies for moderate to large benefits of structured psychological interventions (CBT or IPT) in reducing mother–infant attachment problems at endpoint (p=0.01-0.003) and at long-term follow-up (p=0.16-0.35), mean mother–infant attachment scores (p=0.20), mother–infant play frequency (p <0.00001), and maternal sensitivity (p=0.10). There was, however, no evidence for clinically or statistically significant benefits on mother–infant behaviour management problems (p=0.53-0.56) or mother–infant attachment mean scores at short-term follow-up (p=0.29), and although there was a statistically significant effect of CBT/IPT on exclusive breastfeeding at 6 months, the effect size was too small to be considered clinically meaningful (p=0.02-0.03) (Table 187).
Table 187
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual or enhanced treatment as usual on mother–infant attachment outcomes.
Mother-infant attachment: facilitated self-help versus treatment as usual
There was no evidence for a clinically or statistically significant benefit (p=0.12) of facilitated self-help on maternal attitude towards motherhood (Table 188).
Table 188
Summary of findings table for effects of facilitated self-help compared with treatment as usual on mother–infant attachment outcomes.
Mother-infant attachment: listening visits versus treatment as usual
There was low quality, single study evidence for moderate benefits of listening visits on reducing mother–infant attachment problems (p=0.01-0.06) and behaviour management problems (p=0.12 for ITT analysis). However, the effect on behaviour management problems was not clinically or statistically significant when using an available case analysis approach (p=0.84) and effects on mother–infant attachment problems were not maintained at long-term follow-up (p=0.69-0.89). There were also no clinically or statistically significant effects of listening visits on breastfeeding discontinuation before 6 months (p=0.33-0.36) (Table 189).
Table 189
Summary of findings table for effects of listening visits compared with treatment as usual on mother–infant attachment outcomes.
Mother-infant attachment: social support versus treatment as usual
There were no clinically or statistically significant (p=0.13-0.55) benefits of social support for positive mother–infant feeding or teaching interactions (Table 190).
Table 190
Summary of findings table for effects of social support compared with treatment as usual on mother–infant attachment outcomes.
Mother-infant attachment: psychologically (CBT/IPT)-informed psychoeducation versus enhanced treatment as usual
There was low quality single study (N=194) evidence for a moderate benefit of psychoeducation on maternal sense of competence at post-treatment (p <0.0001), and a small (but not appreciable) benefit maintained at short-term follow-up (p=0.02; Table 191).
Table 191
Summary of findings table for effects of psychologically (CBT/IPT)-informed psychoeducation compared with enhanced treatment as usual on mother–infant attachment outcomes.
Mother-infant attachment: home visits versus treatment as usual
There was no evidence for statistically or clinically significant effects (p=0.23-0.37) of home visits on mother–infant attachment problems (Table 192).
Table 192
Summary of findings table for effects of home visits compared with treatment as usual on mother–infant attachment outcomes.
Mother-infant attachment: mother-infant relationship interventions versus treatment as usual or enhanced treatment as usual
There was mixed, but largely non-significant, evidence for the effects of mother-infant relationship interventions on mother-infant attachment outcomes (Table 193). There was very low quality evidence from two studies (N=175) for a moderate benefit of mother-infant relationship interventions on reducing attachment problems (p ≤0.0001). There was also single study (N=75-95) evidence for moderate benefits of mother-infant relationship interventions on maternal sensitivity and maternal structuring treatment response (reliable change index; p=0.46-0.53) and behaviour management problems (for ITT [p=0.04] but not available case [p=0.62] analysis). However, confidence in the effect estimates for the dichotomous measures of maternal sensitivity and structuring were very low due to risk of bias concerns (statistically significant differences in infant age at baseline and selective reporting bias) and very serious imprecision (as the optimal information size of 300 events was not met and the 95% CIs include appreciable harm, no effect and appreciable benefit). There was also low quality single study (N=58-71) evidence for moderate to large benefits of mother-infant relationship interventions on maternal sensitivity (p=0.001), maternal structuring (p=0.02), child responsiveness (p=0.006), and child involvement (p=0.002) at long follow-up (25-103 weeks post-intervention), but not on maternal nonintrusiveness (p=0.15) or maternal nonhostility (p=0.94) at long-term follow-up, or child attachment security at very long-term (>104 weeks post-intervention) follow-up (p=0.11). In addition, evidence from up to four studies (N=146-378) found no evidence for statistically or clinically significant effects on continuous measures of mother-infant attachment or positive interactions (p=0.47), maternal sensitivity (p=0.15), maternal structuring (p=0.13), or child involvement/positive engagement (p=0.22). There was also no evidence for clinically or statistically significant effects on maternal nonintrusiveness (p=0.72-0.76), child responsiveness (p=0.67-0.69) or child involvement (p=0.96-1.00) dichotomous treatment responses, or continuous measures of maternal intrusive behaviour (p=0.16), maternal nonhostility (p=0.67), maternal sense of competence (p=0.55), child responsiveness (p=0.16), or child attachment security (p=0.06) at endpoint, or mother-infant positive interaction, maternal sensitivity or maternal intrusive behaviour mean scores at intermediate follow-up (p=0.46-1.00), or mother-infant attachment problems at long-term follow-up (p=0.30-0.45). Moreover, there was single study evidence for a large harm (p <0.00001) of mother-infant relationship interventions on mother-infant positive interaction mean scores at very long follow-up with effects favouring enhanced treatment as usual (telephone support).
Table 193
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual or enhanced treatment-as-usual on mother–infant attachment outcomes.
Mother-infant attachment: mother-infant relationship intervention with video feedback versus mother–infant relationship intervention with verbal feedback
A single study compared two mother–infant relationship intervention arms and found no differences in effects on maternal sense of competence or on maternal perceptions of infant behaviour between the intervention arm including video feedback and the intervention arm including verbal feedback (p=0.16-0.58; Table 194).
Table 194
Summary of findings table for effects of mother–infant relationship intervention with video feedback compared with mother–infant relationship intervention with verbal feedback on mother–infant attachment outcomes.
Mother-infant attachment: mother-infant relationship intervention (and facilitated self-help aimed at the eating disorder) versus listening visits (and facilitated self-help aimed at the eating disorder)
There was very low quality single study (N=80) evidence for moderate to large benefits (Table 195) of a mother–infant relationship intervention relative to listening visits for women with eating disorders for reducing mealtime conflict (p=0.01-0.02), maternal inappropriate verbal responses (p=0.06-0.08), and infant autonomy (p=0.01-0.03), but not for maternal intrusions (p=0.38-0.49).
Table 195
Summary of findings table for effects of mother–infant relationship intervention (+ facilitated self-help) compared with listening visits (+ facilitated self-help) on mother–infant attachment outcomes.
7.5.13. Clinical evidence for effects on mental health outcomes (sub-analyses)
Depression outcomes by baseline diagnostic status
There was evidence for statistically significant subgroup differences by baseline diagnostic status for depression diagnosis (ITT analysis [p=0.007]; available case analysis [p=0.03]) with clinically and statistically significant benefits observed for psychosocial interventions on depression diagnosis where the participants had a clinical diagnosis of depression at baseline (usually assessed using a structured psychiatric interview [p <0.00001]), clinically but not statistically significant benefits observed for participants who had baseline symptoms of depression (scored above threshold on a depression rating scale) for ITT analysis or clinically and statistically significant benefits but with a less precise estimate of effect for available case analysis (p=0.008), and no evidence for clinically or statistically significant effects of psychosocial interventions on depression diagnosis for participants with subthreshold symptoms at baseline (p=0.86-0.93).
Depression outcomes by format
There was evidence for statistically significant subgroup differences by format for mean depression symptoms (ITT analysis [p=0.03]) with large benefits of psychosocial interventions delivered in an individual format on mean depression symptoms (p=0.01) but no evidence for clinically or statistically significant benefits of group psychosocial interventions on mean depression symptoms (p=0.65).
Depression outcomes by treatment timing, mode of delivery and intensity
There were no clinically meaningful subgroup differences for the sub-analyses of depression outcomes by treatment timing (for instance, antenatal, postnatal, antenatal and postnatal), mode of delivery (for instance, face-to-face, telephone, internet), or intensity (high [>16 sessions of contact with healthcare professional], moderate [8-16 sessions of contact with healthcare professional]; low [<8 sessions of contact with healthcare professional]).
Sub-analyses for other outcomes
There was insufficient data to enable sub-analysis by baseline diagnosis status, treatment timing, mode of delivery, format or intensity for anxiety, adjustment disorder, PTSD, OCD, general mental health, or mother–infant attachment outcomes.
7.5.14. Clinical evidence for effects of interventions aimed at substance or alcohol misuse
Alcohol use during pregnancy: brief alcohol reduction intervention versus alcohol assessment only
As reviewed in STADE2009B, there was single study evidence (N=142) for a statistically significant effect of a brief alcohol reduction intervention on the number if women who remained abstinent throughout the trial (p=0.04). However, the effect size was small and did not reach the threshold for appreciable clinical benefit (RR 1.20 [1.01, 1.42]). Moreover, there were no clinically or statistically significant treatment effects on the number of women who were abstinent following the trial (RR 1.11 [0.93, 1.33]; p=0.25) or the number of antenatal drinking episodes (SMD -0.20 [-0.45, 0.05]; p=0.12).
Alcohol use during pregnancy: brief cognitive behavioural intervention versus usual advice
As reviewed in STADE2009B, there was single study evidence (N=72) for a moderate effect of a brief cognitive behavioural intervention on the number of women abstaining from alcohol at follow-up (RR 1.25 [0.97, 1.61]). However, this effect was not statistically significant (p=0.09), and there was no evidence for a clinically or statistically significant effect on the average drinks per month (SMD -0.45 [-0.92, 0.02]; p=0.06).
Alcohol use during pregnancy: motivational interviews versus brief written information
As reported in STADE2009B, there was no evidence from a single study (N=34) for clinically or statistically significant effects of motivational interviews on the total standard units of alcohol (SMD -0.05 [-0.73, 0.62]; p=0.88) or days abstinent (SMD 0.32 [-0.36, 1.00]; p=0.36). Two additional studies which met eligibility criteria for this review (OSTERMAN2012, OSTERMAN2014) provided consistent results with no clinically or statistically significant benefits of motivational interviews observed on drink days per week (not estimable), drink days per month (SMD 0.03 [-0.37, 0.44]; p=0.87), harmful drinking behaviour/dependency symptoms (SMD 0.10 [-0.31, 0.51]; p=0.64), psychological needs (SMD 0.14 [-0.39, 0.67]; p=0.61), or motivation to decrease alcohol use (SMD -0.03 [-0.35, 0.30]; p=0.88).
Alcohol use during pregnancy: brief intervention versus routine care
As reported in STADE2009B, there was single study (N=255) evidence for a small and statistically significant effect of a brief intervention for alcohol use on abstinence in the third trimester (RR 1.08 [1.02, 1.14]; p=0.01), although this effect failed to reach the threshold for a clinically appreciable benefit. As reported in STADE2009B, there was however evidence for a large, and clinically and statistically significant, effect of this brief intervention on alcohol reduction in the third trimester (SMD -3.09 [-3.46, -2.73]; p <0.00001). Moreover, an additional study (N=179) identified by this review (MARAIS2011) also found evidence for clinically and statistically significant effects of a brief intervention on alcohol reduction in the third trimester (RR 1.74 [1.31, 2.32]; p=0.0001).
Alcohol use in the postnatal period: psychologically-informed psychoeducation versus control
A single study (N=235) which met eligibility criteria for this review but not for any of the Cochrane reviews (FLEMING2008) found no evidence for clinically significant benefits, although some of the effects reached statistical significance, of a psychologically-informed psychoeducational intervention (based on CBT and motivational interviewing principles) for women who screened positively for at-risk drinking in the postnatal period on total number of standard drinks (SMD -0.35 [-0.61, -0.09]; p=0.007), number of drinking days (SMD -0.14 [-0.40, 0.11]; p=0.27), or number of heavy drinking (≥4 drinks) days (SMD -0.34 [-0.59, -0.08]; p=0.01).
Alcohol use in the postnatal period: home visits versus control
As reported in TURNBULL2012 there was no evidence from two studies (N=248) for clinically or statistically significant benefits of home visits in the postnatal period on continued alcohol use (RR 1.08 [0.83, 1.41]; p=0.55).
Illicit drug use during pregnancy: any psychosocial intervention versus control
As reported in TERPLAN2007 and updated with two studies identified by this review (WINHUSEN2008, YONKERS2012), there was no evidence (N=239-822) for any clinically or statistically significant benefits of psychosocial interventions on retention in treatment (RR 1.02 [0.95, 1.09]; p=0.63) or retention at one month or more (RR 1.07 [0.87, 1.33]; p=0.52).
Illicit drug use during pregnancy: manual-based interventions versus control
As reported in TERPLAN2007, there was no evidence from three studies (N=226) for a clinically or statistically significant effect of manual-based interventions on retention in treatment (RR 0.93 [0.81, 1.06]; p=0.27).
Illicit drug use during pregnancy: contingency management versus control
As reported in TERPLAN2007, there was no evidence from four studies (N=213) for a clinically or statistically significant effect of contingency management on retention in treatment (RR 1.14 [0.98, 1.34]; p=0.09).
Illicit drug use in the postnatal period: contingency management versus control
A long-term follow-up (SILVERMAN2002) of a study included in TERPLAN2007 (Silverman et al., 2001) met the eligibility criteria for this review but not for any of the Cochrane reviews and provided single study (N=40) evidence for a large benefit of contingency management on continued illicit drug abstinence at three year follow-up (RR 5.00 [0.64, 39.06]; p=0.12). However, this effect estimate was imprecise (with a very small sample size and the 95% CI including both no effect and a measure of appreciable benefit) and not statistically significant.
Illicit drug use in the postnatal period: home visits versus control
As reported in TURNBULL2012 there was no evidence from two studies (N=248) for clinically or statistically significant benefits of home visits in the postnatal period on continued illicit drug use (RR 0.95 [0.75, 1.20]; p=0.64). There was evidence from two studies ([N=211] reported in TURNBULL2012) for a large effect of postnatal home visits (in favour of the intervention) on failure to enrol in a drug treatment programme, however, this effect was not statistically significant and there was considerable heterogeneity between effect estimates (RR 0.45 [0.10, 1.94]; p=0.28). There was single study (N=103) evidence (reported in TURNBULL2012) for a moderate, and clinically and statistically significant, benefit of postnatal home visits on failure to remain in drug treatment at 4 weeks (RR 0.54 [0.35, 0.84]; p=0.007). However, this effect was not maintained at 90 days (RR 0.93 [0.69, 1.25]; p=0.63).
Illicit drug use in the postnatal period: self-help versus attention-placebo control
A single study (N=143) which met eligibility criteria for this review but not for any of the Cochrane reviews (ONDERSMA2014) found evidence for a large, and clinically and statistically significant benefit, of self-help on illicit drug abstinence at 13-week follow-up (RR 2.68 [1.20, 5.97]; p=0.02). Moreover, a moderate and clinically significant benefit was maintained at 26-week follow-up (RR 1.41 [0.57, 3.49]; p=0.46), although this effect estimate was imprecise and failed to reach statistical significance.
Depression in the postnatal period: psychologically-informed psychoeducation versus control
A single study (N=205) which met eligibility criteria for this review but not for any of the Cochrane reviews (FLEMING2008) found no evidence for a clinically or statistically significant benefit of a psychologically-informed psychoeducational intervention for women who screened positive for at-risk drinking in the postnatal period on depression at 6-month follow-up (SMD -0.22 [-0.50, 0.05]; p=0.11).
Mother-infant attachment: home visits versus control
As reported in TURNBULL2012 there was no evidence from a single study (N=124) for a clinically or statistically significant benefit of postnatal home visits on the number of women who discontinued breastfeeding before six months (RR 1.00 [0.81, 1.23]; p=1.00).
7.5.15. Clinical evidence for effects on quality of life (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Quality of life: structured psychological interventions (CBT or IPT) versus treatment as usual or enhanced treatment as usual
There was high quality evidence from three studies (N=897) for a moderate benefit of CBT or IPT on social support at post-treatment when an available case analysis was used (p <0.00001). However, the effect estimate from the ITT analysis of a single study (N=93) failed to meet clinical or statistical significance thresholds (p=0.07), though this could be a consequence of a lack of power. Conversely at short-term follow-up, there was single study (N=93) low quality evidence for a moderate benefit of CBT (and home visits) relative to home visits-only on social support using an ITT analysis approach (p=0.003), however, the available case analysis of another single study (N=45) found no evidence for clinically or statistically significant effects of IPT relative to treatment as usual on social support at short-term follow-up (p=0.34) (Table 196).
Table 196
Summary of findings table for effects of structured psychological interventions (CBT or IPT) compared with treatment as usual or enhanced treatment as usual on quality of life outcomes.
There was single study (N=212) low quality evidence for a moderate benefit of CBT relative to treatment as usual on maternal stress (p=0.0001). However, the confidence in this effect estimate was downgraded as the rule-of-thumb threshold for optimal information size (that is, 400 participants) was not met and there was a high risk of selective reporting bias. The same study (N=284) also found evidence for a small effect of CBT relative to treatment as usual on wellbeing (p=0.0005), however, this effect estimate did not meet the criteria for a clinically meaningful and appreciable benefit (as SMD<0.5) (Table 196).
There was single study (N=284) low quality evidence for a small benefit of CBT relative to treatment as usual on functional impairment (p=0.0009), however, again despite statistical significance, the threshold for clinical significance was not reached. Very low quality evidence from four studies (although only two studies included in each analysis [N=146-897]) found no evidence for clinically or statistically significant effects of CBT or IPT relative to treatment as usual or enhanced treatment as usual on life functioning at post-treatment using an available case analysis approach (p=0.91) or an ITT analysis (p=0.70). However, there was single study (N=93) low quality evidence for a moderate benefit of CBT (and home visits) relative to home visits-only on life functioning at short-term follow-up using an ITT analysis approach (p=0.005) (Table 196).
Quality of life: IPT versus support group
A single study (N=44) found no evidence for a clinically or statistically significant benefit of IPT relative to a support group on maternal stress as measured by comparing cortisol levels (p=0.14) (Table 197).
Table 197
Summary of findings table for effects of IPT compared with support group on quality of life outcomes.
Quality of life: facilitated self-help versus treatment as usual
There was single study (N=59-143) very low quality evidence for moderate to large benefits of facilitated self-help relative to treatment as usual on social support (p=0.05), functional impairment (p=0.03), and maternal stress using either an ITT (p=0.02) or available case (p=0.02) analysis approach (Table 198).
Table 198
Summary of findings table for effects of facilitated self-help compared with treatment as usual on quality of life outcomes.
Quality of life: listening visits versus treatment as usual
There was single study (N=277) low quality evidence for small and statistically significant benefits of listening visits on functional impairment (p=0.002) and wellbeing mean scores (p=0.0006), although these effect estimates do not meet criteria for clinical significance (as SMD<0.5). There was also very low quality evidence from another single study (N=41) for a moderate benefit of listening visits on the number of women reporting improvements in wellbeing (p=0.06). However, conversely there was low quality single study (N=211) evidence for a small but statistically significant harm associated with listening visits with higher mean maternal stress scores observed in the intervention group relative to women who received treatment as usual (p=0.001) (Table 199).
Table 199
Summary of findings table for effects of listening visits compared with treatment as usual on quality of life outcomes.
Quality of life: directive counselling versus treatment as usual
There was single study (N=90) low quality evidence for a moderate benefit of directive counselling relative to treatment as usual on social support (p=0.05) (Table 200).
Table 200
Summary of findings table for effects of directive counselling compared with treatment as usual on quality of life outcomes.
Quality of life: post-miscarriage counselling versus treatment as usual
A single study (N=15-19) found evidence for a moderate benefit of post-miscarriage counselling relative to treatment as usual on functional impairment using an available case analysis approach (p=0.21). However, the effect estimate from the ITT analysis did not meet criteria for clinical or statistical significance (p=0.42). Moreover, confidence in these effect estimates was very low due to risk of bias concerns (statistically significant group difference at baseline) and very serious imprecision (Table 201).
Table 201
Summary of findings table for effects of post-miscarriage counselling compared with treatment as usual on quality of life outcomes.
Quality of life: post-traumatic birth counselling versus treatment as usual
There was single study (N=103) low quality evidence for a large benefit of post-traumatic birth counselling relative to treatment as usual on maternal stress symptomatology (p=0.04) (Table 202).
Table 202
Summary of findings table for effects of post-traumatic birth counselling compared with treatment as usual on quality of life outcomes.
Quality of life: social support versus treatment as usual
High to very low quality evidence from up to two studies (N=30-653) found no evidence for clinically or statistically significant effects of social support relative to treatment as usual on social support (p=0.93), maternal cortisol levels (p=0.53), self-esteem (p=0.48), or loneliness at post-treatment (p=0.29) or short-term follow-up (p=0.18). There was low quality evidence from two studies (N=101) for a small and statistically significant benefit of social support on maternal stress (p=0.03), however, this effect estimate did not meet criteria for a clinically meaningful and appreciable benefit (as SMD<0.5) (Table 203).
Table 203
Summary of findings table for effects of social support compared with treatment as usual on quality of life outcomes.
Quality of life: psychologically (CBT/IPT)-informed psychoeducation versus treatment as usual or enhanced treatment as usual
There was single study (N=194) low quality evidence for a moderate benefit of IPT-informed psychoeducation relative to enhanced treatment as usual (non-mental health-focused education and support group) on social support (p <0.00001) at post-treatment, and a small and statistically significant (although no longer clinically meaningful) benefit was maintained at short-term follow-up (p=0.02) (Table 204).
Table 204
Summary of findings table for effects of psychologically (CBT/IPT)-informed psychoeducation compared with treatment as usual or enhanced treatment as usual on quality of life outcomes.
There was also very low quality evidence from two studies (N=128) for a small and statistically significant benefit of CBT- or IPT- informed psychoeducation relative to treatment as usual on functional impairment (p=0.01) at post-treatment (Table 204). However, this effect estimate did not meet criteria for clinical significance (as SMD <0.5). In addition, a single study (N=42) found no evidence for clinically or statistically significant effects of CBT-informed psychoeducation relative to treatment as usual on functional impairment at short-term follow-up (p=0.17).
No evidence was found for clinically or statistically significant effects of psychologically-informed psychoeducation on maternal stress assessed through self-report scales at post-treatment (using an ITT analysis [K=1; N=156; p=0.26] or available case analysis [K=2; N=95; p=0.83]), intermediate follow-up (using an ITT analysis [K=1; N=156; p=0.59] or available case analysis [K=1; N=42; p=0.60]) or long-term follow-up (using an available case analysis [K=1; N=46; p=0.68]). There was also no evidence from a single study (N=53) for clinically or statistically significant effects of CBT-informed psychoeducation relative to treatment as usual on maternal cortisol levels at post-treatment (K=1; N=53; p=0.18). This study (N=46) did find evidence for a moderate benefit at long-term follow-up (p=0.08). However, confidence in this effect estimate was very low due to statistically significant group differences in this outcome measure at baseline (high risk of selection bias), a high risk of selective reporting bias, and very serious imprecision (Table 204).
A single study (N=156) found no evidence for clinically or statistically significant effects of IPT-informed psychoeducation relative to treatment as usual on happiness at post-treatment (p=0.76) or long-term follow-up (p=0.26) (Table 204).
Quality of life: home visits versus treatment as usual or enhanced treatment as usual
There was no evidence for clinically or statistically significant effects of home visits relative to treatment as usual or enhanced treatment as usual on a dichotomous measure of maternal stress (using an ITT [K=1; N=364; p=0.34] or available case [K=1; N=249; p=0.59] analysis approach) or on mean maternal stress scores (K=2; N=595; p=0.62) (Table 205).
Table 205
Summary of findings table for effects of home visits compared with treatment as usual or enhanced treatment as usual on quality of life outcomes.
Quality of life: mother-infant relationship interventions versus treatment as usual or enhanced treatment as usual
There was no evidence for clinically or statistically significant effects of mother– infant relationship interventions on a dichotomous measure of maternal stress (using an ITT [K=1; N=80; p=0.13] or available case [K=1; N=75; p=0.14] analysis approach) or on mean maternal stress scores (K=2; N=173; p=0.70) (Table 206).
Table 206
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual or enhanced treatment as usual on quality of life outcomes.
Quality of life: psychosomatic intervention versus treatment as usual
A single study (N=127) found no evidence for clinically or statistically significant effects of a psychosomatic intervention relative to treatment as usual on poor social support (p=0.30) or maternal stress (p=0.54) (Table 207).
Table 207
Summary of findings table for effects of a psychosomatic intervention compared with treatment as usual on quality of life outcomes.
Quality of life: mindfulness training versus treatment as usual or enhanced treatment as usual
Single study analyses of data from two studies (N=31/47) found no evidence for clinically or statistically significant effects of mindfulness training relative to waitlist control or enhanced treatment as usual (non-mental health-focused education and support [book]) on maternal stress (p=0.46-0.60) or positive affect (p=0.23) (Table 208).
Table 208
Summary of findings table for effects of mindfulness training compared with treatment as usual or enhanced treatment as usual on quality of life outcomes.
7.5.16. Clinical evidence for effects on service utilisation (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Service utilisation: structured psychological interventions (CBT or IPT) versus treatment as usual or enhanced treatment as usual
A single study (N=46-57) found low quality evidence for reduced use of psychotherapy (p=0.06-0.15) and counselling (p=0.05-0.10) associated with IPT relative to treatment as usual and increased use of alternative therapies relative to treatment as usual (p=0.44-0.46). However, confidence in all these effect estimates is low due to very serious imprecision (very small sample size and wide 95% CIs). This study found no evidence for clinically or statistically significant effects of IPT relative to treatment as usual on health visitor use (p=0.90-1.00), antidepressant use (p=0.77-0.86), or use of a self-help support group (p=0.73-0.92) (Table 209).
Table 209
Summary of findings table for effects of structured psychological interventions (CBT or IPT) compared with treatment as usual or enhanced treatment as usual on service utilisation outcomes.
Service utilisation: facilitated self-help versus treatment as usual
There was single study (N=57-83) evidence that participants who received facilitated self-help showed less use of the childbirth hospital (p=0.29-0.50) or mental health hospital (p=0.28-0.46) than participants who received treatment as usual. However, confidence in these effect estimates is very low due to very serious imprecision and high risk of selective reporting bias. This study found no clinically or statistically significant effects associated with facilitated self-help on a continuous measure of childbirth hospital usage (p=0.36), the ITT analysis for use of maternal general health hospital (p=0.39), the use of mental health outpatient services (dichotomous ITT analysis [p=0.93]; dichotomous available case analysis [p=0.65]; continuous available case analysis [p=0.08]); the use of health community services (dichotomous ITT analysis [p=0.98]; dichotomous available case analysis [p=0.91]; continuous available case analysis [p=0.71]), or the use of antidepressants (dichotomous ITT analysis [p=0.47]; dichotomous available case analysis [p=0.57]; continuous available case analysis [p=0.59]). Effect estimates could not be calculated for the available case analysis of maternal general health hospital (continuous or dichotomous outcome measures) or use of mental health hospital mean scores due to zero cell counts (Table 210).
Table 210
Summary of findings table for effects of facilitated self-help compared with treatment as usual on service utilisation outcomes.
Service utilisation: listening visits versus treatment as usual
There was single study evidence (N=601-731) for moderate to large effects of listening visits on service utilisation with listening visits associated with greater usage of NHS health visitor services (p=0.01-0.20) and health visitor telephone contact (p=0.0003-0.08) than treatment as usual. However, it is unclear from the study whether this service utilisation was independent from the intervention and if not, this may be regarded as more of a compliance measure. This same study found evidence for less use of midwife services associated with listening visits relative to treatment as usual when an available case analysis approach was used (p=0.05), however, effects on midwife usage were not clinically or statistically significant when an ITT analysis approach was adopted (p=0.87). There was also no evidence for clinically or statistically significant effects of listening visits on use of maternal general health hospital (p=0.75-0.77) or use of GP (p=0.72-0.74) (Table 211).
Table 211
Summary of findings table for effects of listening visits compared with treatment as usual on service utilisation outcomes.
Service utilisation: social support versus treatment as usual
A single study (N=600-701) found moderate effects of peer-mediated support with the intervention associated with less antidepressant use at post-treatment (p=0.19) and short-term follow-up (p=0.08). However, using an ITT analysis approach effects on antidepressant usage were not clinically or statistically significant (p=0.45-0.54). The same study also found no evidence for clinically or statistically significant effects of peer-mediated support on a continuous measure of health service usage at post-treatment (p=0.35) or short-term follow-up (p=0.82) (Table 212).
Table 212
Summary of findings table for effects of social support compared with treatment as usual on service utilisation outcomes.
7.5.17. Clinical evidence for effects on experience of care (by intervention)
The review of qualitative evidence for experience of care is in Chapter 6, however, this section includes any experience of care outcomes reported in the psychosocial treatment RCTs. Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Experience of care: mother-infant relationship interventions versus treatment as usual or enhanced treatment as usual
A single study (N=98) found no evidence for clinically or statistically significant effects of a mother–infant relationship intervention relative to enhanced treatment as usual (non-mental health-focused education and support [booklet about infant care]) on satisfaction with the intervention (p=0.21) or satisfaction with the therapeutic alliance in that the mother felt understood (p=1.00) (Table 213).
Table 213
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual or enhanced treatment as usual on experience of care outcomes.
7.5.18. Clinical evidence for effects on retention in services and treatment acceptability (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Retention in services and treatment acceptability (using attrition as a proxy measure): structured psychological interventions (CBT or IPT) versus treatment as usual or enhanced treatment as usual
Twelve studies (N=1,983) found no evidence for clinically or statistically significant effects of structured psychological interventions (CBT or IPT) relative to treatment as usual or enhanced treatment as usual on attrition (p=0.41) (Table 214).
Table 214
Summary of findings table for effects of structured psychological interventions (CBT or IPT) compared with treatment as usual or enhanced treatment as usual on retention in services or treatment acceptability (using attrition as a proxy measure).
Retention in services and treatment acceptability (using attrition as a proxy measure): CBT versus relational constructivist therapy
A single study (N=60) found no evidence for a clinically or statistically significant difference between CBT and relational constructivist therapy on attrition (p=0.89) (Table 215).
Table 215
Summary of findings table for effects of CBT compared with relational constructivist therapy on retention in services or treatment acceptability (using attrition as a proxy measure).
Retention in services and treatment acceptability (using attrition as a proxy measure): IPT versus support group
A single study (N=48) found no evidence for a clinically or statistically significant difference between IPT and a support group on attrition (p=1.00) (Table 216).
Table 216
Summary of findings table for effects of IPT compared with support group on retention in services or treatment acceptability (using attrition as a proxy measure).
Retention in services and treatment acceptability (using attrition as a proxy measure): facilitated self-help versus treatment as usual
Three studies (N=1,136) found no evidence for clinically or statistically significant effects of facilitated self-help relative to treatment as usual on attrition (p=0.22) (Table 217).
Table 217
Summary of findings table for effects of facilitated self-help compared with treatment as usual on retention in services or treatment acceptability (using attrition as a proxy measure).
Retention in services and treatment acceptability (using attrition as a proxy measure): listening visits versus treatment as usual
Three studies (N=1,211) found no evidence for clinically or statistically significant effects of listening visits relative to treatment as usual on attrition (p=0.15) (Table 218).
Table 218
Summary of findings table for effects of listening visits compared with treatment as usual on retention in services or treatment acceptability (using attrition as a proxy measure).
Retention in services and treatment acceptability (using attrition as a proxy measure): directive counselling versus treatment as usual
A single study (N=146) found no evidence for clinically or statistically significant effects of directive counselling relative to treatment as usual on attrition (p=0.32) (Table 219).
Table 219
Summary of findings table for effects of directive counselling compared with treatment as usual on retention in services or treatment acceptability (using attrition as a proxy measure).
Retention in services and treatment acceptability (using attrition as a proxy measure): post-miscarriage counselling versus treatment as usual or enhanced treatment as usual
Two studies (N=99) found no evidence for clinically or statistically significant effects of post-miscarriage counselling relative to treatment as usual or enhanced treatment as usual (medical investigations into causes of miscarriage without counselling) on attrition (p=0.63) (Table 220).
Table 220
Summary of findings table for effects of post-miscarriage counselling compared with treatment as usual or enhanced treatment as usual on retention in services or treatment acceptability (using attrition as a proxy measure).
Retention in services and treatment acceptability (using attrition as a proxy measure): post-traumatic birth counselling versus treatment as usual
A single study (N=103) reported no drop-out from post-traumatic birth counselling or treatment as usual and it was therefore not possible to calculate an effect size (Table 221).
Table 221
Summary of findings table for effects of post-traumatic birth counselling compared with treatment as usual on retention in services or treatment acceptability (using attrition as a proxy measure).
Retention in services and treatment acceptability (using attrition as a proxy measure): social support versus treatment as usual
Three studies (N=807) found evidence for a moderate effect of social support relative to treatment as usual on attrition with higher drop-out associated with peer-mediated support or a support group (p=0.18). However, this effect was not statistically significant due to very serious imprecision (Table 222).
Table 222
Summary of findings table for effects of social support compared with treatment as usual on retention in services or treatment acceptability (using attrition as a proxy measure).
Retention in services and treatment acceptability (using attrition as a proxy measure): psychologically (CBT/IPT)-informed psychoeducation versus treatment as usual or enhanced treatment as usual
Thirteen studies (N=2,375) found no evidence for clinically or statistically significant effects of psychologically (CBT/IPT)-informed psychoeducational interventions relative to treatment as usual or enhanced treatment as usual on attrition (p=0.15) (Table 223).
Table 223
Summary of findings table for effects of psychologically (CBT/IPT)-informed psychoeducation compared with treatment as usual or enhanced treatment as usual on retention in services or treatment acceptability (using attrition as a proxy measure).
Retention in services and treatment acceptability (using attrition as a proxy measure): non-mental health-focused education and support versus treatment as usual
A single study (N=331) found no evidence for a clinically or statistically significant effect of a non-mental health-focused education and support intervention relative to treatment as usual on attrition (p=0.73) (Table 224).
Table 224
Summary of findings table for effects of non-mental health-focused education and support compared with treatment as usual on retention in services or treatment acceptability (using attrition as a proxy measure).
Retention in services and treatment acceptability (using attrition as a proxy measure): home visits versus treatment as usual
Four studies (N=1,252) found no evidence for clinically or statistically significant effects of home visits relative to treatment as usual on attrition (p=0.56) (Table 225).
Table 225
Summary of findings table for effects of home visits compared with treatment as usual on retention in services or treatment acceptability (using attrition as a proxy measure).
Retention in services and treatment acceptability (using attrition as a proxy measure): mother-infant relationship interventions versus treatment as usual or enhanced treatment as usual
Five studies (N=576) found no evidence for clinically or statistically significant effects of mother–infant relationship interventions relative to treatment as usual or enhanced treatment as usual on attrition (p=0.22) (Table 226).
Table 226
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual or enhanced treatment as usual on retention in services or treatment acceptability (using attrition as a proxy measure).
Retention in services and treatment acceptability (using attrition as a proxy measure): mother-infant relationship intervention with video feedback versus mother–infant relationship intervention with verbal feedback
A single study (N=51) found no clinically or statistically significant difference on attrition (p=0.79) between a mother–infant relationship intervention with video feedback and a mother–infant relationship intervention with verbal feedback (Table 227).
Retention in services and treatment acceptability (using attrition as a proxy measure): mother-infant relationship intervention (and facilitated self-help) versus listening visits (and facilitated self-help)
There was single study (N=80) evidence for a moderate to large effect on attrition of a mother–infant relationship intervention relative to listening visits (in addition to facilitated self-help aimed at the eating disorder for both groups) with higher dropout observed in the mother–infant relationship intervention group (p=0.56). However, this effect was not statistically significant due to very serious imprecision (Table 228).
Retention in services and treatment acceptability (using attrition as a proxy measure): co-parenting intervention versus enhanced treatment as usual
A single study (N=29) reported no drop-out from a co-parenting intervention or enhanced treatment as usual (monitoring) and it was therefore not possible to calculate an effect size (Table 229).
Table 229
Summary of findings table for effects of co-parenting intervention compared with enhanced treatment as usual on retention in services or treatment acceptability (using attrition as a proxy measure).
Retention in services and treatment acceptability (using attrition as a proxy measure): music therapy during birth versus treatment as usual
A single study (N=141) found no evidence for a clinically or statistically significant effect of music therapy during birth relative to treatment as usual on attrition (p=0.61) (Table 230).
Table 230
Summary of findings table for effects of music therapy during birth compared with treatment as usual on retention in services or treatment acceptability (using attrition as a proxy measure).
Retention in services and treatment acceptability (using attrition as a proxy measure): psychosomatic interventions versus treatment as usual
Two studies (N=276) found no evidence for clinically or statistically significant effects of psychosomatic interventions relative to treatment as usual on attrition (p=0.56) (Table 231).
Table 231
Summary of findings table for effects of psychosomatic interventions compared with treatment as usual on retention in services or treatment acceptability (using attrition as a proxy measure).
Retention in services and treatment acceptability (using attrition as a proxy measure): mindfulness training versus enhanced treatment as usual
A single study (N=47) found evidence for a moderate effect of mindfulness training relative to enhanced treatment as usual (non-mental health-focused education and support [book]) on attrition (p=0.73), with higher drop-out in the mindfulness training group. However, this effect was not statistically significant due to very serious imprecision (Table 232).
Table 232
Summary of findings table for effects of mindfulness training compared with enhanced treatment as usual on retention in services or treatment acceptability (using attrition as a proxy measure).
7.5.19. Clinical evidence for effects on infant service use (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Infant service use: facilitated self-help versus treatment as usual
A single study (N=57-83) found evidence for moderate effects of facilitated self-help on reducing infant hospital use relative to treatment as usual (p=0.22-0.39). However, these effects were not statistically significant due to very serious imprecision and this study found no evidence for clinically or statistically significant effects of facilitated self-help on a continuous measure of infant hospital use (p=0.66) (Table 233).
Table 233
Summary of findings table for effects of facilitated self-help compared with treatment as usual on infant service use.
Infant service use: listening visits versus treatment as usual
There was single study (N=597-731) evidence for moderate effects of listening visits relative to treatment as usual on infant visits to an NHS health visitor at clinic at long-term follow-up with higher service usage in the listening visits group (p=0.06-0.15). However, these effects were not statistically significant due to very serious imprecision and the effects on this outcome measure were not clinically or statistically significant at post-treatment (p=0.81-0.95). This study also found evidence for a moderate effect of listening visits on visits for an infant from an NHS health visitor at home (with more visits observed for the intervention group) when using an available case analysis approach (p=0.08). However, again effect estimates were very imprecise and for this outcome measure the effect was not clinically or statistically significant when an ITT analysis approach was adopted (p=0.55). Moreover, it was unclear from the study whether this service usage was independent from the intervention, and thus, this outcome measure may be interpreted as a compliance measure. A moderate effect of listening visits relative to treatment as usual were observed on infant skin ointment usage with lower usage observed in the intervention group (p=0.006-0.01). A large effect of listening visits on infant asthma medication use was also observed (p=0.10) with lower usage in the listening visit relative to the treatment as usual group when an available case analysis approach was used. However, the effect estimate was very imprecise and the ITT analysis did not reveal any clinically or statistically significant effects on infant use of asthma medication (p=0.31). A small and statistically significant effect of listening visits on infant visits to the GP was found at post-treatment (p=0.02), however, this effect estimate did not meet criteria for clinical significance (as SMD<0.5) and effects were not clinically or statistically significant for infant visits to the GP at long-term follow-up (p=0.40-0.85). Finally, there was no evidence found for clinically or statistically significant effects of listening visits on infant use of hospital (p=0.61-0.75), infant visits to emergency department (measured at post-treatment [p=0.57-0.98] and long-term follow-up [p=0.51-0.87]), any infant medication use (p=0.27-0.47), or antibiotic use (p=0.95-0.96) (Table 234).
Table 234
Summary of findings table for effects of listening visits compared with treatment as usual on infant service use.
Infant service use: home visits versus treatment as usual
A single study (N=268-364) found evidence for a moderate effect of home visits on infant hospitalisations with a lower number observed in the intervention group relative to the treatment as usual group (p=0.009) when an available case analysis approach was used. A small and statistically significant effect on infant hospitalisations was also observed for the ITT analysis, however, the effect estimate no longer met criteria for clinical significance (as RR>0.75). Confidence in these effect estimates was low due to risk of bias concerns (statistically significant group differences at baseline) and the rule-of-thumb threshold for optimal information size (300 events) was not met. This same study found no evidence for clinically or statistically significant effects of home visits on the number of children who were seen in an emergency department department (p=0.55-0.57). Another single study (N=138) found evidence for a moderate effect of home visits but this time in favour of the treatment as usual group with a higher administration of medication to the child without the advice of a medical practitioner in the home visit group (p=0.15). However, confidence in this effect estimate was very low due to risk of bias concerns (statistically significant group differences at baseline) and very serious imprecision (optimal information size threshold not reached and 95% CI includes both no effect and appreciable harm) (Table 235).
Table 235
Summary of findings table for effects of home visits compared with treatment as usual on infant service use.
Infant service use: mother-infant relationship interventions versus treatment as usual or enhanced treatment as usual
A single study (N=95-121) found low quality evidence for moderate harms associated with a mother–infant relationship intervention relative to enhanced treatment as usual (non-mental health-focused education and support [booklet about infant care]) on infant hospitalisation (after discharge from NICU) and contact with specialized healthcare services with higher infant service use in the intervention group (p=0.15-0.39) when an available case analysis approach was used. However, effects on infant hospitalisation and contact with specialized healthcare services were not clinically or statistically significant when an ITT analysis approach was adopted (p=0.13-0.32). This study found no evidence for clinically or statistically significant effects on contact with developmental/rehabilitation specialist (p=0.59-0.69), use of any medication (p=0.13-0.15), surgery after discharge from NICU (p=0.55-0.86), or use of oxygen therapy (p=0.64-0.95) (Table 236).
Table 236
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual or enhanced treatment as usual on infant service use.
7.5.20. Clinical evidence for effects on infant physical health (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Infant physical health: structured psychological interventions (CBT or IPT) versus treatment as usual or enhanced treatment as usual
A single study (N=705-903) found evidence for a moderate effect of CBT relative to enhanced treatment as usual (home visits) on the incidence of severe infant diarrhoea with a lower incidence in the intervention group when an available case analysis approach was used (p=0.003). The ITT analysis of this outcome measure also found a statistically significant effect (p=0.01) but the effect estimate no longer met criteria for clinical significance (as RR>0.75). This same study found no evidence for clinically or statistically significant effects of CBT on measures of infant weight (underweight [p=0.18-0.24] or weight-for-age [p=0.09]). With the exception of one statistically but not clinically significant effect estimate this study also found no evidence for clinically or statistically significant effects of CBT on measures of infant height (stunted height [p=0.09-0.28] or height-for-age [p=0.002]) (Table 237).
Table 237
Summary of findings table for effects of structured psychological interventions (CBT or IPT) compared with treatment as usual or enhanced treatment as usual on infant physical health.
Infant physical health: IPT versus support group
A single study (N=44) found no evidence for clinically or statistically significant differences between IPT and a support group for gestational age (p=0.33) or birthweight (p=0.78) (Table 238).
Table 238
Summary of findings table for effects of IPT compared with support group on infant physical health.
Infant physical health: listening visits versus treatment as usual
There was single study (N=650-731) low quality evidence for a moderate effect of listening visits relative to treatment as usual on maternal concerns about their child's health when using an available case analysis approach (p=0.07). However, the ITT analysis did not find a clinically or statistically significant effect (p=0.12) (Table 239).
Table 239
Summary of findings table for effects of listening visits compared with treatment as usual on infant physical health.
Infant physical health: social support versus treatment as usual
A single study (N=23) found no evidence for a clinically or statistically significant effect of peer-mediated support (with mother–infant relationship intervention content) relative to a waitlist control on infant cortisol levels (p=0.52) (Table 240).
Table 240
Summary of findings table for effects of social support compared with treatment as usual on infant physical health.
Infant physical health: psychologically (CBT/IPT)-informed psychoeducation versus treatment as usual or enhanced treatment as usual
A single study (N=46-53) found no evidence for clinically or statistically significant effects of a CBT-informed psychoeducational intervention relative to treatment as usual on infant stress assessed by the mother using a visual analogue scale (p=0.40) or infant cortisol levels measured at post-treatment (p=0.32) or long-term follow-up (p=0.72) (Table 241).
Table 241
Summary of findings table for effects of psychologically (CBT/IPT)-informed psychoeducation compared with treatment as usual or enhanced treatment as usual on infant physical health.
Infant physical health: mother-infant relationship intervention (and facilitated self-help) versus listening visits (and facilitated self-help)
A single study (N=77) found no evidence for a clinically or statistically significant effect of a mother–infant relationship intervention relative to listening visits (both of which were in addition to facilitated self-help aimed at the eating disorder) on infant weight (p=0.61) (Table 242).
Table 242
Summary of findings table for effects of mother–infant relationship intervention (and facilitated self-help) compared with listening visits (and facilitated self-help) on infant physical health.
7.5.21. Clinical evidence for effects on infant physical development (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Infant physical development: CBT versus listening visits
A single study (N=34) found no evidence for a clinically or statistically significant difference between CBT and listening visits on infant motor development (p=0.54) (Table 243).
Table 243
Summary of findings table for effects of CBT compared with listening visits on infant physical development.
Infant physical development: listening visits versus treatment as usual
A single study (N=591-731) found very low quality evidence for a moderate effect of listening visits relative to treatment as usual on infant eating habits when an available case analysis was used (p=0.05). However, an ITT analysis of infant eating habits found no evidence for a clinically or statistically significant treatment effect (p=0.40). This study also found no evidence for clinically or statistically significant effects of listening visits on infant sleeping habits (p=0.54-0.68) (Table 244).
Table 244
Summary of findings table for effects of listening visits compared with treatment as usual on infant physical development.
Infant physical development: home visits versus treatment as usual
A single study (N=249-364) found very low quality evidence for a moderate effect of home visits relative to treatment as usual on reducing infant motor development impairment when an available case analysis approach was used (p=0.28). However, the ITT analysis did not find a clinically or statistically significant effect (p=0.19). Another study (N=138) found no evidence for clinically or statistically significant effects of home visits on infant feeding problems (p=0.25) or infant sleep problems (p=0.28) (Table 245).
Table 245
Summary of findings table for effects of home visits compared with treatment as usual on infant physical development.
Infant physical development: mother-infant relationship interventions versus treatment as usual or enhanced treatment as usual
A single study (N=96) found no evidence for a clinically or statistically significant effect of a mother–infant relationship intervention relative to enhanced treatment as usual (non-mental health-focused education and support [booklet about infant care]) on infant motor development (p=0.56) (Table 246).
Table 246
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual or enhanced treatment as usual on infant physical development.
Infant physical development: infant sleep training (controlled crying) versus treatment as usual
There was low to very low quality evidence from two studies (N=184-272) for moderate effects of infant sleep training (controlled crying) relative to treatment as usual on infant sleep problems at post-treatment (p=0.13) and at short-term follow-up (p=0.03). Although clinical and statistical significance was not maintained at long-term follow-up (p=0.34) (Table 247).
Table 247
Summary of findings table for effects of infant sleep training (controlled crying) compared with treatment as usual on infant physical development.
7.5.22. Clinical evidence for effects on infant cognitive development (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Infant cognitive development: CBT versus listening visits
A single study (N=34) found no evidence for a statistically or clinically significant difference between CBT and listening visits on infant IQ (p=0.10) (Table 248).
Table 248
Summary of findings table for effects of CBT compared with listening visits on infant cognitive development.
Infant cognitive development: listening visits versus treatment as usual
A single study (N=591) found very low quality evidence for a large effect of listening visits relative to treatment as usual on maternal concerns about infant verbal development when an available case analysis approach was used (p=0.01). However, the ITT analysis for this outcome measure (N=731) was not clinically or statistically significant (p=0.37). This same study (N=640-731) also found no evidence for clinically or statistically significant effects of listening visits on maternal concerns about infant development (p=0.73-0.95) (Table 249).
Table 249
Summary of findings table for effects of listening visits compared with treatment as usual on infant cognitive development.
Infant cognitive development: social support versus treatment as usual
A single study (N=48) found no evidence for a clinically or statistically significant effect of peer-mediated support (with mother–infant relationship intervention content) relative to a waitlist control on infant IQ (p=0.47) (Table 250).
Table 250
Summary of findings table for effects of social support compared with treatment as usual on infant cognitive development.
Infant cognitive development: home visits versus treatment as usual
A single study (N=249-364) found no evidence for clinically or statistically significant effects of home visits relative to treatment as usual on infant intellectual impairment (p=0.08-0.12) (Table 251).
Table 251
Summary of findings table for effects of home visits compared with treatment as usual on infant cognitive development.
Infant cognitive development: mother-infant relationship interventions versus treatment as usual or enhanced treatment as usual
A single study (N=96) found no evidence of a clinically or statistically significant effect of a mother–infant relationship intervention relative to enhanced treatment as usual (non-mental health-focused education and support [booklet about infant care]) on infant IQ (p=0.74) and two studies (N=154) found no evidence for clinically or statistically significant effects of mother–infant relationship interventions relative to enhanced treatment as usual (non-mental health-focused education and support [booklet about infant care] or telephone support) on infant verbal development (p=0.58) (Table 252).
Table 252
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual or enhanced treatment as usual on infant cognitive development.
7.5.23. Clinical evidence for effects on infant emotional development (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Infant emotional development: social support versus treatment as usual
A single study (N=51) found no evidence for a clinically or statistically significant effect of peer-mediated support (with mother–infant relationship intervention content) relative to waitlist control on maternal-rated infant ‘difficult’ temperament (p=0.25) (Table 253).
Table 253
Summary of findings table for effects of social support compared with treatment as usual on infant emotional development.
Infant emotional development: home visits versus treatment as usual
There was single study (N=249) very low quality evidence for a moderate effect of home visits relative to treatment as usual on infant internalizing using an available case analysis approach (p=0.08). However, ITT analysis for this outcome measure (N=364) found no evidence for a clinically or statistically significant effect (p=0.08). This study (N=249-364) also found no evidence for clinically or statistically significant effects of home visits on infant externalizing (p=0.24-0.38). Another study (N=160-440) found a similar pattern of treatment effects on infant social withdrawal with low quality evidence for a moderate effect on a dichotomous measure using available case analysis (p=0.09) but no evidence for clinically or statistically significant effects on ITT analysis of the same dichotomous measure (p=0.25) or on a continuous measure of infant social withdrawal (p=1.00) (Table 254).
Table 254
Summary of findings table for effects of home visits compared with treatment as usual on infant emotional development.
Infant emotional development: mother-infant relationship interventions versus treatment as usual or enhanced treatment as usual
Two studies (N=146) found no evidence for clinically or statistically significant effects of mother–infant relationship interventions relative to treatment as usual or enhanced treatment as usual on a continuous measure of infant adaptive behaviour (p=0.61). In addition, one of those studies (N=75-80) also found no evidence for clinically or statistically significant effects of mother–infant psychotherapy relative to treatment as usual on dichotomous measures of infant adaptive behaviour (p=0.58-0.62) (Table 255).
Table 255
Summary of findings table for effects of mother–infant relationship interventions compared with treatment as usual or enhanced treatment as usual on infant emotional development.
A single study (N=58-71) found no evidence for clinically or statistically significant effects of a mother–infant relationship intervention relative to enhanced treatment as usual (non-mental health-focused education and support [booklet about infant care]) on infant externalizing (p=0.72) or infant dysregulation (p=0.75) at post-treatment or infant externalizing at very long-term follow-up (p=0.60). The same study also found no clinically or statistically significant treatment effects on infant internalizing at post-treatment (p=0.21). However, at very long-term follow-up there was evidence for a large harm associated with a mother–infant relationship intervention with more severe infant internalizing mean scores observed in the intervention group relative to the enhanced treatment as usual group (p <0.00001). This study did, however, find low quality evidence for a large benefit of a mother–infant relationship intervention on infant self-esteem (p <0.00001) (Table 255).
Infant emotional development: infant sleep training (controlled crying) versus treatment as usual
A single study (N=268) found no evidence for clinically or statistically significant effects of infant sleep training (controlled crying) on infant externalizing (p=0.60) or internalizing (p=0.86) (Table 256).
Table 256
Summary of findings table for effects of infant sleep training (controlled crying) compared with treatment as usual on infant emotional development.
7.5.24. Clinical evidence for prevention of neglect or abuse of the infant (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Prevention of neglect or abuse of the infant: listening visits versus treatment as usual
A single study (N=596-731) found no evidence for clinically or statistically significant effects of listening visits relative to treatment as usual on the incidence of child injury requiring medical attention at post-treatment (p=0.78-0.97) or long-term follow-up (p=0.19-0.76) (Table 257).
Table 257
Summary of findings table for effects of listening visits compared with treatment as usual for prevention of neglect or abuse of the infant.
Prevention of neglect or abuse of the infant: home visits versus treatment as usual
A single study (N=138) found evidence for a large effect of home visits relative to treatment as usual on preventing the child ingesting poison (p=0.14). However, confidence in this effect estimate was very low due to a high risk of selection bias (statistically significant group differences at baseline) and very serious imprecision. Single study analyses of the data from this and one other study found no evidence for clinically or statistically significant effects of home visits relative to treatment as usual on child injury (p=0.58-0.75), child protective service reports of all types (p=0.73-0.82), child protective service reports of neglect (p=0.71-0.78), or maternal use of punishment (p=0.50-0.68). There was also no evidence for a clinically significant effect (although the effect was statistically significant) of home visits on a continuous measure of potential for child abuse (p=0.05) (Table 258).
Table 258
Summary of findings table for effects of home visits compared with treatment as usual for prevention of neglect or abuse of the infant.
7.5.25. Clinical evidence for effects on optimal infant care (by intervention)
Summary of findings can be found in the tables presented in this section. The full GRADE evidence profiles and associated forest plots can be found in Appendix 22 and Appendix 19, respectively.
Optimal infant care: structured psychological interventions (CBT or IPT) versus treatment as usual or enhanced treatment as usual
A single study (N=705-9.3) found no evidence for clinically significant effects (although effects were statistically significant) of CBT relative to enhanced treatment as usual (home visits) on complete immunisation (p=0.04-0.0001) (Table 259).
Table 259
Summary of findings table for effects of structured psychological interventions (CBT or IPT) compared with treatment as usual or enhanced treatment as usual on optimal care of the infant.
7.5.26. Health economics evidence
Systematic literature review
The systematic literature search identified three eligible UK studies (Hewitt et al., 2009; Paulden et al., 2009; Morrell et al., 2009a; Stevenson., 2010a [HTA]; Stevenson et al., 2010b) and one Canadian study (Dukhovny et al., 2013) that assessed the cost effectiveness of psychosocial interventions in postnatal women with mental health problems. All four identified studies assessed the cost effectiveness of psychosocial interventions for depression in the postnatal period. Details on the methods used for the systematic search of the economic literature are described in Chapter 3. References to included studies and evidence tables for all economic studies included in the guideline systematic literature review are presented in Appendix 21. Completed methodology checklists of the studies are provided in Appendix 20. Economic evidence profiles of studies considered during guideline development (that is, studies that fully or partly met the applicability and quality criteria) are presented in Appendix 22, accompanying the respective GRADE clinical evidence profiles.
Paulden and colleagues (2009) evaluated the cost-utility of structured psychological therapy and listening visits compared with standard care in women with postnatal mild to severe depression managed in primary care. This treatment model was part of a model which was used to assess the cost-utility of screening for depression in the postnatal period in primary care in the UK. Hewitt and colleagues (2009) reported the same analysis as part of the Health Technology Assessment report. The time horizon of the analysis was 12 months and the perspective of the NHS and PSS was adopted. The effectiveness data were derived from meta-analysis of RCTs. The study estimated intervention costs including clinical psychologist, health visitor, GP and CPN; and also additional costs associated with standard postnatal care for women with depression in the postnatal care. Costs associated with infant care were not included in the estimation of costs, owing to lack of relevant data. The resource use estimates were based on studies that provided efficacy data and where necessary were supplemented with authors' assumptions. The unit costs were obtained from national sources. The measure of outcome for the economic analysis was the QALY.
The expected mean QALYs per woman were 0.7489, 0.7513 and 0.7036 for the structured psychological therapy, listening visits and standard care groups, respectively. The expected incremental cost (relative to standard care) per woman over 12 months was £792 for structured psychological therapy and £947 for listening visits in 2006-2007 prices. The cost per QALY associated with the structured psychological therapy was £17,480 when compared with standard care which is below NICE's lower cost-effectiveness threshold value of £20,000 per QALY; however when using uplifted cost (to 2013/2014 prices) the ICER goes just above £20,000 per QALY (that is, £20,732). The cost per QALY associated with listening visits was £66,275 when compared with structured psychological therapy. Probabilistic analysis indicated that at WTP of £20,000-£30,000 per QALY the probability that structured psychological therapy is cost effective is 0.504-0.549; the probability that listening visits is the most cost-effective intervention is 0.276-0.414 and the probability that standard care is cost effective is 0.220-0.037. Results suggest that structured psychological therapy is the most cost-effective treatment among those assessed, for women with depression in the postnatal period. Even though listening visits resulted in slightly higher number of QALYs, the considerably higher cost of this strategy resulted in a cost per QALY versus structured psychological therapy that was well above the cost-effectiveness threshold of £20,000-£30,000 per QALY considered to represent value for money.
The analysis was judged by the GDG to be directly applicable to this guideline review and the NICE reference case. This was a UK-based study and the outcome measure of the economic analysis was the QALY; however the utility values were derived from the general population with depression treated with antidepressant medication. The relative effect between structured psychological therapy and listening visits was based on indirect comparisons between treatments, using standard care as the baseline common comparator, due to lack of head-to-head comparisons between the two interventions. Some of resource use was informed by expert opinion; costs associated with infant care were excluded due to the lack of relevant data. Nevertheless, given the limited availability of data this was a well conducted study and was judged by the GDG to have only minor methodological limitations.
Morrell and colleagues (2009a) assessed the cost effectiveness of listening visits, CBT or standard care. The authors also compared the intervention group as a whole (not differentiating between listening visits and CBT) with standard care. The intervention involved health visitor training in systematically identifying depressive symptoms and delivering psychologically informed sessions based on either CBT or listening visits at GP practice. Standard care was defined as care shared between the midwife and a GP, or otherwise consultant-led care based on clinical need. The study population comprised women with EPDS score ≥12 at 6-weeks after childbirth. The mean baseline EPDS of the study sample was 15.2 (SD 3.0) and their mean age was 31 years. This was an economic evaluation undertaken alongside a cluster randomised RCT (MORRELL2009A) that involved 101 general practices (clusters) in 29 primary care trusts in the UK. The efficacy data was derived from RCT (n=418 at 6 months, n=123 at 12 months). The time horizon of the main analysis was 6 months; secondary analysis reported cost effectiveness at 12 months. The perspective of the NHS and PSS was adopted. The study estimated costs associated with health visitor training, health visitor visits, GP contacts, prescriptions, social worker contacts, MBU, paediatric admissions, community mental health contacts, walk-in centre attendances, emergency department attendances and NHS direct contacts. The resource use estimates were based on data collected alongside the RCT (n=248 at 6 months, n=123 at 12 months), expert opinion and authors' assumptions. The unit costs were obtained from national sources and from the RCT (that is, costs pertaining to health visitor training). The measure of outcome for the economic analysis was the QALY.
At 6 months the mean QALYs gained per woman was 0.026 for the intervention group and 0.023 for the standard care group, a difference of 0.003 QALYs (95% CI, -0.004 to 0.010). The mean cost per woman over 6 months was £339 for the intervention group and £374 for the standard care group in 2003/04 prices, a difference of -£35 (95% CI, -£137 to £67). According to the analysis the intervention group provides better outcome at lower cost, and thus is a dominant intervention when compared with the standard care group at 6 months. Furthermore, according to the probabilistic analysis at WTP of £20,000-£30,000 per QALY the probability that the intervention group is cost effective was just above 0.70. Comparing CBT and listening visits with standard care, CBT resulted in QALY gains of 0.004 (0.027 versus 0.023) and listening visits in 0.002 (0.025 versus 0.023). Similarly, CBT resulted in cost savings of £45 (£329 versus £374) and listening visits of £21 (£353 versus £374) when compared with standard care. As a result, CBT was found to be dominant compared with listening visits and standard care, and at WTP of £20,000-£30,000 per QALY the probability that CBT is cost effective was approximately 0.70.
At 12 months the mean number of QALYs gained per woman was 0.117 for the intervention group and 0.107 for the standard care group, a difference of 0.010 QALYs (95% CI, 0.000 to 0.021). The mean cost per woman over 12 months was £763 for the intervention group and £772 for the standard care group, a difference of -£9 (95% CI, -£177 to £159). According to the analysis the intervention group provides better outcome at lower cost, and thus is a dominant intervention when compared with standard care. At WTP of £20,000-£30,000 per QALY the probability that the intervention group is cost effective was estimated to be just over 0.80. There was no difference between CBT and listening visits at 12 months. Overall the results suggest that psychological interventions are cost effective for women with depression in the postnatal period in the UK.
The analysis was judged by the GDG to be directly applicable to this guideline review and the NICE reference case. This was a UK-based study and the outcome measure was the QALY. QALYs were estimated based on SF-36 data, which were converted into utility scores using the SF-6D algorithm and preferences from the UK general population (Brazier et al., 2002). Some of resource use estimates were based on expert opinion and the authors' assumptions; also some of the costs were trial-specific which may limit the generalisability of the findings. Moreover, the attrition rate was quite high. As a result it may have been underpowered to detect differences between CBT and listening visits at 12 months. Overall, this was a well conducted economic analysis and was judged by the GDG to have only minor methodological limitations.
Stevenson and colleagues (2010b) evaluated the cost-utility of CBT-informed psychoeducation compared with standard care in the UK. Stevenson and colleagues (2010a) reported the same analysis as part of Health Technology Assessment report. CBT-informed psychoeducation entailed one session per week for eight weeks, which was of two hour duration and was held in groups of four to six women. Standard care was defined as routine primary care that included visits by midwives and health visitor, GP care, medication, community mental health contacts and social services. This was an economic evaluation based on a small RCT (HONEY2002) (n=45) and modelling. The study population comprised women with EPDS ≥ 12; the mean baseline EPDS of the study sample was 19.5 (SD 4.17). Efficacy data were taken from the RCT. The RCT provided efficacy data at baseline, end of treatment (that is, 8 weeks), and at 6-month follow-up. Based on clinical advice, it was assumed in the base-case analysis that the incremental gain in EPDS of CBT-informed psychoeducation compared with standard care would rise linearly to a peak value at 8 weeks (that is, at the end of intervention), stay constant until 6 months, and then decline linearly to zero by 12 months after randomisation (that is, it was assumed that no effect is retained at 12 months). The incremental gain was assumed to decline to zero at 12 months because symptoms of depression were no longer assumed to be postnatal in origin by that time point. The time horizon of the analysis was 12 months and the perspective of the NHS and PSS was adopted. It was assumed that standard care costs were the same across both groups; consequently the authors estimated only the costs associated with the provision of CBT-informed psychoeducation. The resource use estimates were based on the RCT, other published studies and authors' assumptions. The unit costs were obtained from published studies. The measure of outcome for the economic analysis was the QALY. In order for QALYs to be estimated a mapping technique was utilised. To do this data was obtained from the PoNDER trial (Morrell et al., 2009a), which collected data on both EPDS and SF-36; the statistical relationship between EPDS and SF-36 and the SF-6D algorithm that converts SF-36 into utility values (Brazier et al., 20024) were subsequently used to transform the observed gains in EPDS recorded in HONEY2002 RCT into utility values that could be utilised in the economic model.
The pooled comparative advantage in EPDS was estimated to be 3.98 points (95% CI, 0.23 to 6.73) in favour of the intervention. Using the mapping technique it was estimated that CBT-informed psychoeducation resulted in a QALY gain of 0.032 (95% CI, 0.025 to 0.041). The incremental cost associated with CBT-informed psychoeducation over 12 months was £1,500 per woman. The cost year of the analysis was 2007/08. The ICER associated with CBT-informed psychoeducation was estimated to be £46,462 per QALY gained (95% CI, £37,008 to £60,728). The sensitivity analysis showed that when the cost of intervention per woman was decreased to £750 (that is, a reduction of 50%), the ICER decreased to £23,231 per QALY; and when the cost of intervention was increased to £2,000 per woman, the ICER increased to £61,948 per QALY. Using the lower estimate of efficacy (that is, EPDS advantage of 3.27 in favour of intervention) the cost per QALY increased to £56,626 and using an upper estimate (that is, EPDS advantage of 4.69 in favour of intervention) it was £39,481. Moreover, assuming a linear decline in advantage of CBT-informed psychoeducation extended to 18 months (instead of the 12 months assumed in the base-case analysis), the resulting ICER became £34,382 per QALY; assuming a QALY gain associated with CBT-informed psychoeducation of 0.02 per woman resulted in a cost per QALY of £28,846. The authors also conducted a scenario analysis where the cost of intervention per woman was decreased to £1,000, the change in EPDS scores was assumed to be 4.3 in favour of CBT-informed psychoeducation, and a linear decline in advantage of group CBT was extended to 18 months. The scenario resulted in a cost per QALY of £19,230 which is just below NICE's lower cost-effectiveness threshold value. Considering the results of the various scenarios explored in sensitivity analysis, the authors concluded that their findings were too uncertain to draw any firm conclusions on the cost effectiveness of CBT-informed psychoeducation in women with depression in the postnatal period.
Nevertheless, the base-case analysis and majority of scenarios explored suggest that CBT-informed psychoeducation is unlikely to be cost-effective intervention in women with depression in the postnatal period at 12 months since the cost per QALY is well above NICE cost-effectiveness threshold of £20,000-£30,000 per QALY considered to represent value for money. Also, the GDG considered that the exclusion of set-up costs and additional running costs such as crèche facilities potentially underestimated the costs associated with the intervention. Nevertheless, the actual cost of CBT-informed psychoeducation based on the resource utilisation reported in RCT was £1,317 and based on the resource use estimates deemed most appropriate by the authors' expert opinion it was £1,246. Moreover, the authors considered only interventions costs, and ignored potential cost-savings resulting from a reduction in depression symptoms.
The analysis was judged by the GDG to be directly applicable to this guideline review and the NICE reference case. This was a UK-based study and outcome measure used was the QALY. QALYs were estimated using mapping technique. Moreover, the estimate of relative treatment effect was obtained from a single small RCT and the authors made a series of assumptions regarding the efficacy of CBT-informed psychoeducation beyond the duration of the RCT. Similarly, the resource use was based on the same small RCT and where necessary it was supplemented with the authors' assumptions. Nevertheless, the authors partially addressed these limitations by conducting extensive sensitivity analyses. Overall, this study was judged by the GDG to have potentially serious methodological limitations.
In a recent study Dukhovny and colleagues (2013) assessed the cost effectiveness of social support (that is, telephone-based peer support service) compared with standard care for women at high-risk for depression in the postnatal period. However, since all of the women in RCT scored >9 on the EPDS and 39% scored >12 the study was classified as treatment study for this guideline review, even though the authors aimed the intervention to be preventative. This was an economic evaluation undertaken alongside an RCT (DENNIS2009) (n=612) conducted in Canada. Social support entailed peer volunteers making a minimum of four telephone contacts initiated 48 to 72 hours after randomisation and continuing through the first 12 weeks after childbirth. Standard care was defined as mother proactively seeking services from public health nurses, physicians, other providers, and various community resources, including drop-in centres. The time horizon of the analysis was 12 weeks and a societal perspective was adopted; however the authors reported costs for different cost categories separately, which enabled estimation of costs from a healthcare perspective. The study estimated public health costs, volunteer opportunity cost, hired housework, hired child care, family/friend and partner time off work, nursing visits, provider visits, mental health visits, and inpatient admissions. The resource use estimates were based on the RCT (n=610) and the unit costs were obtained from local and national sources. The authors used number of cases of depression avoided as an outcome in their economic analysis; however since this study was classified as treatment study for this guideline review the outcome was redefined as number of cases with EPDS score ≤12.
Intervention resulted in a greater proportion of cases with EPDS score ≤12. Percentage of women with EPDS score of ≤12 was 87% and 75% in the intervention and standard care groups, respectively (difference of 11%, p <0.05). The costs in the study were measured in Canadian dollars in 2011 prices. From a healthcare payer perspective the mean cost per mother–infant dyad over 12 weeks was $1,694 for the intervention and $1,080 for standard care, difference of $614. From a societal perspective the mean cost per mother–infant dyad over 12 weeks was $4,497 for the intervention and $3,380 for standard care, difference of $1,117 (p<0.05). The cost per additional woman with EPDS score ≤12 was $10,009 and $5,582 from a societal perspective (plus informal care) and a healthcare payer perspective, respectively. Sensitivity analysis was conducted only on the results from a societal perspective. As the number of healthcare visits was varied between 50% and 400% of the number used in the base-case analysis, the ICER ranged from $9,671 to $9,110 per additional case with EPDS score of ≤12. The ICER was most sensitive to the cost of running the programme, volunteer time, family/friend and partner work absence. Moreover, probabilistic analysis showed that at WTP of $20,196 per case with EPDS score of ≤12 the probability of the intervention being cost effective was 0.95. Results suggest that intervention provides better outcomes but at an additional cost.
The analysis was judged by the GDG to be partially applicable to this guideline review and the NICE reference case. The study was conducted in Canada where the healthcare system is sufficiently similar to the UK NHS. The authors did not attempt to estimate QALYs which made it difficult to interpret the cost effectiveness results and to compare the findings with other studies. Also, a mixture of local and national unit costs were utilised which may limit the generalisabiltiy of the findings to other settings. Moreover, the effectiveness was based on one RCT and the time horizon was only 12 weeks which may not be sufficient to reflect all important differences in costs and outcomes. Also, the sensitivity analysis was conducted only on the results derived using a societal perspective. As a result, the study was judged by the GDG to have potentially serious methodological limitations.
Overall conclusions from existing economic evidence
The existing economic evidence on psychological and psychosocial interventions for the treatment of mental health problems in women who are pregnant or in the postnatal period is very sparse and limited to depression in the postnatal period. The systematic literature search identified three UK-based economic evaluations that were all judged by the GDG to be directly applicable to the NICE decision-making context. Two of the studies included in the review were characterised by minor methodological limitations and one by potentially serious limitations. In one of the studies the structured psychological therapy was found to be cost-effective option when compared with standard care, as it resulted in an ICER of £17,480 per QALY; however when using uplifted cost (to 2013/2014 prices) the ICER goes just above £20,000 per QALY. In another study psychological therapy resulted in better outcomes at lower cost, and thus was found to be dominant when compared with standard care. The third study indicated that CBT-informed psychoeducation was not cost effective compared with standard care. The results of the Canadian study were inconclusive, as they do not use QALYs and it is difficult to judge whether the reported extra benefits associated with the intervention are worth the extra costs associated with its provision.
Economic modelling
Introduction – objective of economic modelling
The provision of psychological and psychosocial interventions aimed at treating depression during postnatal period in women with subthreshold/mild to moderate depression was identified by the GDG as an area with potentially significant resource implications. The existing economic evidence was not sufficient to support decision making by the GDG, consequently a decision-analytic model was developed to assess the cost effectiveness of different types of psychological and psychosocial interventions added to standard postnatal care, relative to standard postnatal care alone, for the treatment of depression in the postnatal period.
The study population
The study population consisted of women with subthreshold/mild to moderate depression in the postnatal period.
Economic modelling methods
Interventions assessed
The economic model considered interventions that were found to be effective in the meta-analysis conducted for this guideline. Two different types of treatments were considered:
- facilitated self-help added to standard postnatal care
- listening visits added to standard postnatal care
In addition, standard postnatal care alone was considered as an alternative option, in order for the active treatments to be assessed.
Model structure
The economic model was developed in the form of a decision tree using Microsoft Office Excel 2013. According to the model structure, hypothetical cohorts of 1,000 women with subthreshold/mild to moderate depression in the postnatal period received one of the treatments assessed. At the end of treatment (that is, 7 weeks), women either improved or did not improve. Women were followed for 1 year since initiation of treatment. Over this period, women who improved, either remained in this state or relapsed. Responders to treatment in each trial that provided efficacy data for the model were calculated on an intention-to-treat basis (that is, response rates were estimated for those who were randomised in each arm and not only for those who completed treatment); consequently discontinuation has not been considered separately in the model. A schematic diagram of the decision-analytic model is presented in Figure 11.
Figure 11
Schematic diagram of the structure of the economic model.
Costs and health benefit measures included in the analysis
The analysis adopted the perspective of the NHS and PSS. Costs consisted of treatment costs (facilitated self-help or listening visits), and health and social care costs for mother–infant dyad. Standard postnatal care costs were omitted from the analysis, because they were common to all therapeutic options assessed. Other costs to women and family, such as personal expenses and productivity losses were also excluded as they were beyond the scope of the analysis. Intangible costs (negative impact of the woman's depression on infant's cognitive and emotional development as well as distress to the family) were also not estimated, but they should be taken into account when interpreting the results.
Two different measures of health benefits were used in the economic analysis:
- Number of women who improved and did not relapse at the end of 1-year follow-up
- Number of quality adjusted life years (QALYs) gained at the end of 1-year follow-up.
Total costs and health benefits associated with each treatment were estimated and combined in order to assess the relative cost effectiveness of the treatment options evaluated.
Effectiveness data and other input parameters of the economic model
Effectiveness data used in the economic model were derived from the guideline meta-analyses. All studies providing dichotomous efficacy data on facilitated self-help and listening visits in the study population were considered in the economic analysis. The types of treatments examined in each of the studies considered are presented in Table 260.
Table 260
Types of treatments of depression in the postnatal period examined in the clinical studies considered in the economic analysis.
Since there were no direct comparisons between the treatments under assessment, it was decided to perform an indirect comparison between them. In order to do this, relative risks of non-improvement (efficacy) of each of the two treatments versus standard care were used, with standard care serving as the baseline common comparator. The absolute rate of non-improvement associated with standard care were based on the whole dataset of studies evaluating treatments for depression in the postnatal period, included in the guideline systematic review, that had a ‘standard care’ arm (that is, all studies reported in Table 260).
The absolute risks of non-improvement of each treatment were estimated by multiplying the respective relative risks for each treatment, derived from meta-analysis, by the absolute risk of non-improvement as calculated for standard care, using the formula:
where:
- NIARint(i) = absolute risk of non-improvement of each treatment
- NIRRint(i) = relative risk of non-improvement of each treatment versus standard care
- NIARst care = absolute risk of non-improvement of standard care
It is acknowledged that the indirect comparison between treatments may have introduced some degree of bias in the analysis, as there were differences between the studies in terms of severity of depression in study samples, diagnostic measures used, content of treatments and comparators, and some other aspects of protocol design. Nevertheless, due to the limited availability of data, the indirect comparison was considered necessary in order to populate the economic model.
Estimation of relapse risk
The risk of relapse over 12 months was assumed to be common to women improving following treatment as well as to women having improved under standard care. No studies reporting relapse rates for the study population were identified. As a result it was assumed that a mean of 50% of women would relapse over 12 months. Relapse rates were utilised in the model for the estimation of benefits in the form of QALYs and also in the estimation of additional costs due to relapse.
Utility data and estimation of QALYs
Similarly to the economic model described in Chapter 5 (section 5.3.6), utility values for this economic analysis were taken from the study by Sapin and colleagues (2004). Utility scores for ‘subthreshold/mild to moderate’ depression in the model were approximated using utility scores reported in Sapin and colleagues (2004) for ‘slightly/moderately ill’. Based on the GDG expert opinion ‘no depression’ health state in the model was approximated using utility scores for ‘first signs’ depression reported in the study; the value of which was also very similar to utility scores reported for ‘responder remitters’.
The use of these data in the cost-utility analysis performed for this guideline is characterised by a number of limitations:
- Data express the HRQoL of the general population of service users with depression and are not specific to women with depression in the postnatal period. However, this period is associated with wide physical and emotional events in women's lives, which are likely to further affect their HRQoL.
- Data refer to utility weights of service users under antidepressant medication, and therefore may incorporate aspects of treatment such as the presence of side effects that are not relevant to the treatments examined in this analysis.
- Data refer to women's HRQoL, and they do not take into account that of the babies, which is subsequently affected by their mother's psychological condition. Although, it would be very difficult to actually measure the babies HRQoL and express it in utility weights, this parameter should be considered in the interpretation of the results.
In the model women who improved were assumed to experience a linear improvement in their HRQoL (expressed in QALYs) from initiation to the end of treatment. Women who relapsed within the first year were assumed to experience a linear deterioration in their HRQoL from the time of relapse until the model endpoint. Women who have not improved where assumed to remain in their original health state (that is, depressed health state) until the model endpoint.
All effectiveness rates and other input parameters included in the economic model are provided in Table 261.
Table 261
Effectiveness data and other input parameters included in the model.
Cost data
Since no patient-level data in terms of resource use were available, the economic analysis was based on deterministic costing of the treatment options. Relevant healthcare resource use was estimated and subsequently combined with UK unit prices to provide costs associated with each treatment strategy assessed. Estimated resource use associated with the two treatments evaluated (facilitated self-help and listening visits) was based on definitions of the treatments in the studies that provided the efficacy data. Further healthcare resource use required was based on the GDG expert opinion, owing to lack of research-based evidence.
Petrou and colleagues (2002) estimated the economic costs of depression in the postnatal period in a geographically defined cohort of women at high risk of developing the condition. Health and social care costs were estimated based on 206 women recruited from antenatal clinics and their babies. The study estimated costs associated with community care, day care services, hospital outpatient attendances, hospital inpatient admissions, and paediatric and child care services. The reported health and social care costs for women with depression in the postnatal period were utilised in the model to estimate health and social care costs associated with women who haven't improved or those who have relapsed. Similarly, women who have improved were assigned health and social care costs associated with women with no depression in the postnatal period.
Unit prices were taken from national sources (Curtis, 2013). All costs utilised in the analysis reflect 2013-2014 prices. Discounting of costs was not applied, as the time horizon of the analysis was 1 year and 7 weeks. Table 118 shows the estimated resource use and total costs associated with each treatment option.
Handling uncertainty
In order to take into account the uncertainty characterising the model input parameters, a probabilistic analysis was undertaken, in which input parameters were assigned probability distributions, rather than being expressed as point estimates (Briggs et al., 2006). Subsequently, 1000 iterations were performed, each drawing random values out of the distributions fitted onto the model input parameters. Mean costs and QALYs for each intervention were then calculated by averaging across 1000 iterations.
The relative risk of non-improvement associated with facilitated self-help and listening visits were given a log-normal distribution. The absolute risk of non-improvement were given a beta distribution. Beta distributions were also assigned to utility values and relapse rate. Costs were assigned a gamma distribution. The estimation of distribution ranges was based on available data in the published sources of evidence, and further assumptions where relevant data were not available. Table 261 provides details on the types of distributions assigned to each input parameter and the methods employed to define their range.
One-way sensitivity analyses (run with the point estimates rather than the distributions of the input parameters) explored the impact of the uncertainty characterising the model input parameters on the model's results:
- changes in relative risk estimates
- changes in the absolute risk of non-improvement associated with standard care
- changes in utility weights
- changes in treatment costs
Moreover, threshold sensitivity analyses were also conducted to explore the magnitude of change in base-case values of input parameters required for the conclusions from cost-utility analysis to be reversed.
Data analysis and presentation of the results
Results of the economic analysis are presented as follows:
For each intervention mean total costs, number of women improving and not relapsing at the end of model, and QALYs are presented, averaged across 1000 iterations of the model. An incremental analysis is provided, where all options have been ranked from the most to the least effective (in terms of QALYs gained). Options that are dominated by absolute dominance (that is, they are less effective and more costly than one or more other options) are excluded from further analysis. Subsequently, Incremental Cost Effectiveness Ratios (ICERs) are calculated for all pairs of consecutive options remaining in analysis.
ICERs are calculated by the following formula:
where ΔC is the difference in total costs between two interventions and ΔE the difference in their effectiveness (QALYs). ICERs express the extra cost per extra unit of benefit (that is, QALY in this analysis) associated with one treatment option relative to its comparator. The treatment option with the highest ICER below the NICE lower cost-effectiveness threshold of £20,000 per QALY (NICE, 2008) is the most cost-effective option.
Moreover, for the most cost-effective intervention, the probability that this is the most cost-effective option is also provided, calculated as the proportion of iterations (out of the 1000 iterations run) in which the intervention was the most cost effective among all interventions considered in the analysis.
Validation of the economic model
The economic model (including the conceptual model and the excel spreadsheet) was developed by the health economist working on this guideline and checked by a second modeller not working on the guideline. The model was tested for logical consistency by setting input parameters to null and extreme values and examining whether results changed in the expected direction. The results were discussed with the GDG for their plausibility.
Economic modelling results
Results of the probabilistic analysis are presented in Table 262. Facilitated self-help dominated listening visits as it resulted in more women who have improved and not relapsed at the end of model, in greater gains in QALYs and at the same time it was also less costly. Facilitated self-help compared with standard care was overall more effective and more costly. The ICER of facilitated self-help was £2,269 per additional woman improving and not relapsing at the end of the model, or £13,324 per QALY gained, which is well below NICE's cost-effectiveness threshold of £20,000-£30,000 per QALY gained, indicating that facilitated self-help is likely a cost-effective option compared with standard care. The cost-effectiveness plane showing the incremental costs and QALYs of facilitated self-help versus standard care, facilitated self-help versus listening visits and listening visits versus standard care resulting from 1000 iterations of the model is shown in Figure 12. The probability of facilitated self-help being cost effective at the NICE cost-effectiveness threshold of £20,000-£30,000 per QALY is 0.59 to 0.72. In Figure 13 cost-effectiveness acceptability curve is presented showing the probability of facilitated self-help being cost effective at various threshold values.
Table 262
Results of the probabilistic analysis referring to a hypothetical cohort of 1,000 women with subthreshold/mild to moderate depression in the postnatal period.
Figure 12
Cost-effectiveness plane showing incremental costs and QALYs of facilitated self-help versus standard care, facilitated self-help versus listening visits, and listening visits versus standard care (per woman). Results based on 1000 iterations
Figure 13
Cost-effectiveness acceptability curve showing the probability of facilitated self-help being cost effective at various threshold values.
One-way sensitivity analyses showed that increasing the relative risk of non-improvement associated with facilitated self-help by approximately 20% (from the base-case value of 0.73 to 0.87) would increase the cost per QALY associated with facilitated self-help (relative to standard care) to £29,797 per QALY which is just below NICE's upper cost-effectiveness threshold of £30,000 per QALY. Moreover, only if the relative risk of non-improvement associated with listening visits was reduced to 0.50 (from the base-case value of 0.96), listening visits would be the preferred treatment option with cost per QALY of £19,353 (when compared with facilitated self-help). As the absolute risk of no improvement (that is, 0.61) associated with standard care is varied the conclusions do not change. Only, if it is as low as 0.25 the standard care would become the preferred option; however this would imply the spontaneous recovery rate (rate of improvement) associated with standard care of 0.75 which is unrealistic in clinical practice. Also, if the utility value associated with subthreshold/mild to moderate depression was increased to 0.81 the ICER of facilitated self-help versus standard care would be above NICE's upper cost-effectiveness threshold, and standard care would be the preferred option (that is, an ICER of £30,420 per QALY). In a scenario where treatment costs were varied by 50% either way of their base-case estimates the conclusions did not change. Overall sensitivity analysis indicates that the conclusions of this analysis are very robust to changes in the model's inputs, and only large changes in the base-case values would be required for the model's conclusions to change.
Discussion – limitations of the analysis
Based on the results of the economic analysis, it can be concluded that facilitated self-help is likely to be a cost-effective treatment option for women with subthreshold/mild to moderate depression in the postnatal period. Facilitated self-help was found to be dominant when compared with listening visits, and resulted in an ICER of £13,324 per QALY gained when compared with standard care. The probability of facilitated self-help being cost effective at the NICE cost-effectiveness threshold of £20,000-£30,000 per QALY was 0.59 to 0.72.
Results were driven by the superior efficacy (expressed by the relative risk of non-improvement) of facilitated self-help and the relatively low intervention costs. It should be noted that clinical benefits from treatment are expected to be higher than those estimated in the analysis, since improvement in women's psychological condition has a significant positive impact on babies' cognitive and emotional development, as well as on the well-being of their wider family.
The economic analysis was undertaken using the most accurate effectiveness and cost data available. However, evidence on clinical effectiveness was based on indirect comparisons between treatments, derived from a very limited number of studies. Cost estimates were based on the description of relevant healthcare resource use as provided in the clinical studies, further supported by the GDG opinion.
Utility weights used in the model referred to HRQoL of the general population of service users with depression and not women with depression in the postnatal period. The quality of life of babies and of the wider family associated with the mother's development of depression in the postnatal period was not addressed in the analysis, as relevant data weren't available.
It is recognised that, overall, results of the analysis are subject to some uncertainty regarding some input parameters and potential bias; nevertheless as indicated by the extensive sensitivity analysis the conclusions are robust to changes in model's inputs.
Further research is needed on the efficacy and acceptability of psychological and psychosocial treatments for the management of women with depression in the postnatal period, on the HRQoL of women with this condition and their babies, and on the long-term costs of health and social care of those babies, in order to determine more accurately the relative cost effectiveness of psychological treatments and assist decision making.
Overall conclusions from economic evidence
The existing economic evidence on psychological and psychosocial interventions for the treatment of mental health problems in pregnancy or the postnatal period is very sparse and limited to depression. Even though the search has identified three UK-based economic evaluations that were all judged by the GDG to be directly applicable to the NICE decision-making context, the studies have not looked at the interventions that were found to be clinically effective in the meta-analysis conducted for this guideline review. In the economic analysis conducted for this guideline, low cost interventions such as facilitated self-help appear to be more cost-effective options than listening visits or standard care. However, the analysis has not overcome many of the limitations characterising previous studies conducted in the area. For example clinical effectiveness was based on indirect comparisons between treatments, derived from a very limited number of studies, some of the resource use estimates were based on the GDG expert opinion and utility values were for the general population with depression. The aforementioned limitations should be considered when making recommendations.
7.6. LINKING EVIDENCE TO RECOMMENDATIONS
In reviewing the evidence for psychosocial interventions aimed at mental health problems in pregnancy and/or the postnatal period the GDG were guided by the principle that much of the treatment of mental health problems in pregnancy and the postnatal period is not different from that at other times of a woman's life, and so should be guided by relevant NICE guidelines for the specific mental health problem. However, new recommendations were developed where there was new evidence specifically for this guideline:
- for an intervention that was specific to pregnancy or the postnatal period;
- that an existing recommendation needed to be clarified or modified as a result of concerns about the health of the fetus or infant;
- that changes are necessary to the context in which interventions are delivered;
- that specific variations are necessitated by changes in a woman's mental or physical health linked to pregnancy and the postnatal period.
In line with these principles, the GDG identified the change to the risk-benefit ratio when considering pharmacological and psychosocial treatments as an instance which necessitated modification to existing guidance for women who are planning a pregnancy, are pregnant, or are breastfeeding. Moreover, the GDG felt that it was a key priority that treatment decisions and discussions be informed by a consideration and trade-off of risks associated with changing or stopping medication during pregnancy (see Chapter 8), the higher threshold for pharmacological interventions due to potential teratogenic harms (see Chapter 8), and the greater prioritisation of prompt and effective psychological interventions. The GDG were particularly mindful that in cases where the optimal treatment is combined psychosocial and pharmacological treatment, but the woman declines or stops taking medication, it is important that she is adequately supported and has the opportunity to discuss the risk associated with stopping psychotropic medication and is offered, or can continue with, a psychological intervention.
These principles also guided the GDG in the decision to restrict the inclusion criteria for study design to RCTs, and exclude observational studies, for the review of treatment efficacy. It was considered appropriate to restrict review to the highest level of the evidence hierarchy so as to enable consistent linking with other NICE guidance based on wider populations.
Crucial to the effective delivery of any psychosocial intervention is the competence of the staff who are delivering it, and non-adherence with treatment models is associated with a significant attenuation in treatment effects. The GDG reviewed the recommendation from the guideline on depression in adults (NICE, 2009a) and agreed with the need for effective supervision and process-and-outcome monitoring and accordingly adapted the recommendation for women with mental health problems in pregnancy or the postnatal period. The GDG also stressed the importance of prompt delivery and highlighted this as another instance where existing recommendations needed to be modified as more urgent intervention may be required in pregnancy or the postnatal period (than would usually be the case) because of the potential effect of the untreated mental health problem on the fetus/baby and on the woman's physical health and care, and her ability to function and care for her family. The GDG reviewed the previous 2007 recommendation which specified that psychological treatment should be initiated within 1-3 months post-assessment and expressed concerns that women may be placed on waiting lists for assessment so that waiting times for treatment may be considerably longer than the 1-3 month time period outlined. In order to remove this potential ambiguity and ensure prompt delivery, the GDG recommended time scales for assessment (assess for treatment within 2 weeks of referral) and treatment initiation (provide psychological interventions normally within 1 month of initial assessment).
There was very low to high quality evidence from up to three studies for moderate clinical benefits of facilitated self-help on depression symptomatology (scoring above threshold on a depression rating scale) and mean depression symptoms for women with subthreshold to moderate symptoms of depression in pregnancy or the postnatal period. The economic analysis conducted for this guideline also found facilitated self-help to be dominant when compared with listening visits, and result in an ICER of £13,324 per QALY gained when compared with standard care. The probability of facilitated self-help being cost effective at the NICE cost-effectiveness threshold of £20,000-£30,000 per QALY was 0.59 to 0.72. Results were driven by the superior efficacy of facilitated self-help and the relatively low intervention costs. The GDG considered this evidence together with what is known about the clinical and cost effectiveness of facilitated self-help for the treatment of depression in non-pregnant women, and recommended that facilitated self-help should be considered for women with persistent subthreshold depressive symptoms, or mild to moderate depression, and delivered as described in recommendation 1.4.2.2 of the guideline on depression in adults (NICE, 2009a), including the provision of written materials, supported by a trained practitioner (face-to-face or by telephone) and typically consisting of six to eight sessions over nine to twelve weeks.
There was very low to high quality evidence from up to ten studies for large to moderate benefits of structured psychological interventions (CBT or IPT) on depression diagnosis, depression symptomatology and depression mean symptoms, and some low quality evidence for maintained moderate to large effects at short-term and intermediate follow-up periods. There was also low quality, single study evidence for a large effect of structured psychological interventions on mean anxiety symptoms for women with a diagnosis or symptoms of depression. The economic evidence review also suggested that structured psychological interventions may be cost effective. In the UK studies reviewed structured psychological therapy resulted in a cost per QALY that was within NICE's cost-effectiveness threshold values of £20,000-£30,000 per QALY (when compared with standard care) or was the dominant intervention. Moreover at WTP of £20,000-£30,000 per QALY structured psychological therapy had a greater than 50% probability of being a cost-effective strategy. The GDG considered this evidence together with the much larger evidence base for the clinical and cost effectiveness of structured psychological interventions for the treatment of depression in non-pregnant populations, and took the view that women with moderate to severe depression in pregnancy or the postnatal period should be offered a range of options in line with existing NICE guidance. In adapting existing NICE guidance the GDG took into account the higher threshold for pharmacological intervention for pregnant or breastfeeding women. The range of treatment options include structured psychological interventions alone, pharmacological interventions alone (providing the woman understands the risks and expresses a preference), or combined structured psychological (CBT or IPT) interventions and psychotropic medication in the case of a limited response to either psychological or pharmacological interventions alone. For the evidence for pharmacological interventions and decisions regarding recommendations specifically about drug treatment see Chapter 8.
There was limited evidence for the effectiveness of a pre-delivery psychoeducational discussion on fear of childbirth (symptoms of tokophobia). There were no clinically or statistically significant effects on mode of delivery. However, there was single study evidence for small and statistically significant benefits of pre-delivery discussions on continuous measures of feeling safe during childbirth, the experience of fear during childbirth, and maternal attitude to motherhood. The economic evidence review did not find any studies assessing the cost-effectiveness of pre-delivery interventions for tokophobia. Although the evidence for large and appreciable benefits was not found, the GDG agreed by consensus judgement, that it is important for women with tokophobia to have the opportunity to discuss these fears during the pre-delivery period and they should have access to a healthcare professional with expertise in providing perinatal mental health support. Moreover, the GDG judged that the cost of such interventions would be small relative to the reduction in women's potential for developing mental health problems and other health vulnerabilities which may be costly to other parts of the NHS. Moreover, this recommendation is in line with NICE guidance on caesarean section (NICE, 2011e).
There was no evidence for statistically or clinically significant benefits (or harms) associated with post-traumatic birth counselling on PTSD outcomes for women who had a diagnosis of PTSD. Based on this inconclusive evidence base there were no grounds for recommending postnatal-specific intervention and the GDG recommended that women with PTSD which has resulted from a traumatic birth, miscarriage, stillbirth or neonatal death should be treated in line with the guideline on PTSD (NICE, 2005a). The GDG reviewed the recommendation from the previous 2007 guideline and judged that the term ‘single-session formal debriefing’ may be misinterpreted as it is used to refer to post-delivery discussions (without an explicit focus on ‘re-living’ the traumatic experience) in an obstetric context, therefore the decision was taken to modify the previous recommendation and replace the term ‘formal debriefing’ with ‘high-intensity psychological interventions with an explicit focus on ‘re-living’ the trauma’. The GDG also wished to highlight that this guidance applied to women who had experienced a birth as psychologically traumatic (even when the delivery is obstetrically straight forward), and that this guidance also applied for women experiencing trauma symptoms in a pregnancy subsequent to a traumatic birth, miscarriage, stillbirth or neonatal death.
There was no other evidence for the treatment of anxiety disorders in pregnancy or the postnatal period. NICE guidelines for specific anxiety disorders did not specifically include recommendations for people with persistent subthreshold symptoms of anxiety. However, the GDG considered the evidence base for low-intensity interventions for depression in this guideline and in non-pregnant populations, taking into account the increased risk of anxiety disorders in pregnancy and the potential for harm on the fetus associated with maternal anxiety. Based on expert consensus judgement, the GDG recommended that facilitated self-help be considered for women with persistent subthreshold symptoms of anxiety in pregnancy or the postnatal period, and delivered consistently with facilitated self-help recommended for persistent subthreshold symptoms of depression, namely using CBT-based self-help materials over two to three months and being supported in using the materials (either face-to-face or by telephone) for a total of two to three hours over six sessions. In the absence of evidence for the treatment of an axiety disorder in pregnancy, the GDG considered it reasonable to extrapolate from a non-pregnant population, and recommended that low-intensity or high-intensity psychological interventions be offered in line with recommendations as set out in the NICE guidelines for Generalised Anxiety Disorder and Panic Disorder (NICE, 2011a), Obsessive-Compulsive Disorder (NICE, 2005b), Social Anxiety Disorder (NICE, 2013a) and Post-Traumatic Stress Disorder (NICE, 2005a). The GDG considered it important to highlight that only high-intensity psychological interventions are recommended for PTSD, high-intensity psychological interventions are the first-line treatment for social anxiety disorder, and healthcare professionals should be aware that progress needs to be closely monitored and stepped up to a high-intensity psychological intervention within two weeks.
There was no evidence for the treatment of severe mental illness (psychosis, schizophrenia and bipolar disorder) in pregnancy or the postnatal period, and the GDG considered that a psychological intervention in line with the guidelines on Psychosis and Schizophrenia in Adults (NICE, 2014) and Bipolar Disorder (NICE, 2006) should be considered, particularly for women who have stopped taking psychotropic medication when they find out they are pregnant, or are changing their medication to one with a lower risk profile.
There was no evidence for the treatment of eating disorders in pregnancy or the postnatal period, and the GDG considered that a psychological intervention in line with the guideline on eating disorders (NICE, 2004a) should be offered. The GDG were, however, concerned about the potential for misinterpretation of advice that it is not necessary ‘to eat for two’ as validation for continuing with restrictive calorie intake or purging and the GDG recommended, based on consensus judgement and clinical opinion, that the importance of healthy eating during pregnancy and the postnatal period should be discussed, and the woman's condition should be monitored carefully throughout pregnancy and the postnatal period, including assessing the need for a fetal growth scan. The GDG also recommended that women with eating disorders in the postnatal period should be advised about, and supported in, feeding their baby, based on consensus opinion and the findings of the qualitative review of experience of care (see Chapter 6), where the need for individualized infant feeding advice for women with eating disorders emerged as a theme.
There was low quality, single study evidence for large effects associated with post-traumatic birth counselling for women who had experienced a physically traumatic birth on depression and anxiety symptomatology. However, there was also evidence for harms associated with post-traumatic birth counselling with a large effect favouring treatment as usual for a continuous measure of feelings of self-blame. These inconsistent effects may be indicative of the need for individualized information and support following a miscarriage or an obstetrically traumatic birth and this was also a theme which emerged from the qualitative review of service user experience (Chapter 6). Thematic analysis of post-traumatic birth experiences also highlighted benefits of partner involvement in discussion and debriefing (Chapter 6). Based on the quantitative and qualitative evidence, and GDG consensus opinion, the GDG recommended that women who have had a traumatic birth or miscarriage and wish to talk about their experience should be offered advice and support, and the effect of the birth or miscarriage on the partner should be taken into account.
The evidence for protocols associated with stillbirth was inconclusive with data suggestive of both benefits and harms. Data from one nested cohort study suggested that there may be harms associated with seeing and/or holding the stillborn infant, conversely findings from two cohort studies imply that there may be benefits associated with spending as much time with the stillborn infant as women wished or holding the stillborn infant. These equivocal findings are also observed in the qualitative review of service user experience (Chapter 6) where mixed opinions and experiences of photographs and mementoes following termination of a pregnancy because of fetal abnormality highlight the importance of individualised treatment. The mixed evidence, importance of individual choice and potential for harm led the GDG to consider protocols following stillbirth as a key priority for implementation and recommended that women together with their partner and family should be offered the option of seeing a photograph of the baby, keeping mementoes of the baby such as handprints or footprints, and seeing and/or holding the baby, and should have the opportunity to discuss these options and be supported in their decision making. This should be facilitated by an experienced healthcare professional and the woman and her partner and family should be offered a follow-up appointment in primary or secondary care. The GDG were also mindful that planning should be incorporated into care plans and discussions for women who know in advance during pregnancy that their baby has died in utero. This was also an emerging theme in the qualitative review of service user experience (Chapter 6) where women expressed a desire to be provided with information and support to prepare them for making a decision about whether to see and/or hold the dead baby and for decisions about a funeral.
The GDG recognised that mental health problems may affect the mother-baby relationship and that women may be reluctant to disclose problems, and in light of potentially important safeguarding issues, recommended that assessment and monitoring of the mother–infant relationship (including verbal interaction, emotional sensitivity and physical care) should be a part of all postnatal assessments, including discussion of any concerns that the woman has about her relationship with her baby, and provision of information and treatment for the mental health problem. The evidence for interventions which directly targeted the mother–infant relationship was mixed, but largely non-significant. This inconclusive evidence prompted the GDG to recommend a definitive trial of a mother–infant relationship intervention that examines clinical and cost effectiveness and reports on the mental health of the woman, the emotional and cognitive development of the baby, and the quality of the interaction with a follow-up period of at least two years. The GDG were mindful that for some women problems in the mother-baby relationship may resolve with effective treatment of the mental health problem and for these women reassurance may be important. There was some evidence (of high to low quality from up to two studies) that treating the depression with structured psychological interventions (CBT or IPT) may have indirect statistically and clinically meaningful benefits on mother–infant attachment and there was some evidence that benefits may be maintained at long-term follow-up. However, the GDG were also aware that problems in the mother-baby relationship may not always or automatically resolve following intervention targeted at the mental health problem, and for these women further intervention for the mother-baby relationship should be considered.
7.7. RECOMMENDATIONS
7.7.1. Clinical recommendations
Using and modifying NICE guidelines for specific mental health problems
Assessment and treatment in pregnancy and the postnatal period
- 7.7.1.1.
Use this guideline in conjunction with the NICE guideline for a specific mental health problem (see the related NICE guidance in section 3.2 [in the NICE guideline]) to inform assessment and treatment decisions in pregnancy and the postnatal period, and take into account:
- any variations in the nature and presentation of the mental health problem in pregnancy or the postnatal period
- the setting for assessment and treatment (for example, primary or secondary care services or in the community, the home or remotely by phone or computer)
- recommendations 5.4.8.5 5.4.8.5 to 5.4.8.10 in this guideline on assessment in pregnancy and the postnatal period
- recommendations 8.9.1.6 to 8.9.1.33 in this guideline on starting, using and stopping treatment in pregnancy and the postnatal period
- recommendations 5.4.8.13 to 5.4.8.14, 7.7.1.6 to 7.7.1.17 and 8.9.1.35 to 8.9.1.48 in this guideline on treating specific mental health problems in pregnancy and the postnatal period. [new 2014]
Treatment decisions, advice and monitoring for women who are planning a pregnancy, pregnant or in the postnatal period
Starting, using and stopping treatment
General advice
- 7.7.1.2.
Before starting any treatment in pregnancy and the postnatal period, discuss with the woman the higher threshold for pharmacological interventions arising from the changing risk–benefit ratio for psychotropic medication at this time and the likely benefits of a psychological intervention. [new 2014]
- 7.7.1.3.
If the optimal treatment for a woman with a mental health problem is psychotropic medication combined with a psychological intervention, but she declines or stops taking psychotropic medication in pregnancy or the postnatal period, ensure that:
- she is adequately supported and
- has the opportunity to discuss the risk associated with stopping psychotropic medication and
- is offered, or can continue with, a psychological intervention. [new 2014]
Providing interventions in pregnancy and the postnatal period
- 7.7.1.4.
All interventions for mental health problems in pregnancy and the postnatal period should be delivered by competent practitioners. Psychological and psychosocial interventions should be based on the relevant treatment manual(s), which should guide the structure and duration of the intervention. Practitioners should consider using competence frameworks developed from the relevant treatment manual(s) and for all interventions practitioners should:
- receive regular high-quality supervision
- use routine outcome measures and ensure that the woman is involved in reviewing the efficacy of the treatment
- engage in monitoring and evaluation of treatment adherence and practitioner competence – for example, by using video and audio tapes, and external audit and scrutiny where appropriate. [new 2014]12
- 7.7.1.5.
When a woman with a known or suspected mental health problem is referred in pregnancy or the postnatal period, assess for treatment within 2 weeks of referral and provide psychological interventions within 1 month of initial assessment. [new 2014]
Treating specific mental health problems in pregnancy and the postnatal period
Interventions for depression
- 7.7.1.6.
For a woman with persistent subthreshold depressive symptoms, or mild to moderate depression, in pregnancy or the postnatal period, consider facilitated self-help (delivered as described in recommendation 1.4.2.2 of the guideline on depression in adults [NICE clinical guideline 90]). [new 2014]
- 7.7.1.7.
For a woman with moderate or severe depression in pregnancy or the postnatal period, consider the following options:
- a high-intensity psychological intervention (for example, CBT)
- a TCA, SSRI or (S)NRI if the woman understands the risks associated with the medication and the mental health problem in pregnancy and the postnatal period and:
- -
she has expressed a preference for medication, or
- -
she declines psychological interventions, or
- -
her symptoms have not responded to psychological interventions,
- a high-intensity psychological intervention in combination with medication if the woman understands the risks associated with the medication and the mental health problem in pregnancy and the postnatal period and there is no response, or a limited response, to a high-intensity psychological intervention or medication alone. [new 2014]
- 7.7.1.8.
If a woman who is taking a TCA, SSRI or (S)NRI for mild to moderate depression becomes pregnant, discuss stopping the medication gradually and consider facilitated self-help (delivered as described in recommendation 1.4.2.2 of the guideline on depression in adults [NICE clinical guide 90]). [new 2014]
- 7.7.1.9.
If a pregnant woman is taking a TCA, SSRI or (S)NRI for moderate depression and wants to stop her medication, take into account previous response to treatment, stage of pregnancy, risk of relapse, risk associated with medication and her preference, and discuss with her the following options:
- switching to a high-intensity psychological intervention (for example, CBT)
- changing medication if there is a drug that is effective for her with a lower risk of adverse effects. [new 2014]
- 7.7.1.10.
If a pregnant woman is taking a TCA, SSRI or (S)NRI for severe depression, take into account previous response to treatment, stage of pregnancy, risk of relapse, risk associated with medication and her preference, and discuss with her the following options:
- continuing with the current medication
- changing medication if there is a drug that is effective for her with a lower risk of adverse effects
- combining medication with a high-intensity psychological intervention (for example, CBT)
- switching to a high-intensity psychological intervention (for example, CBT) if she decides to stop taking medication. [new 2014]
Interventions for anxiety disorders
- 7.7.1.11.
For a woman with tokophobia (an extreme fear of childbirth), offer an opportunity to discuss her fears with a healthcare professional with expertise in providing perinatal mental health support in line with section 1.2.9 of the guideline on caesarean section (NICE clinical guideline 132). [new 2014]
- 7.7.1.12.
For a woman with persistent subthreshold symptoms of anxiety in pregnancy or the postnatal period, consider facilitated self-help. This should consist of use of CBT-based self-help materials over 2–3 months with support (either face to face or by telephone) for a total of 2–3 hours over 6 sessions. [new 2014]
- 7.7.1.13.
For a woman with an anxiety disorder in pregnancy or the postnatal period, offer a low-intensity psychological intervention (for example, facilitated self-help) or a high-intensity psychological intervention (for example, CBT) as initial treatment in line with the recommendations set out in the NICE guideline for the specific mental health problem and be aware that:
- only high-intensity psychological interventions are recommended for post-traumatic stress disorder
- high-intensity psychological interventions are the initial treatment for social anxiety disorder
- progress should be closely monitored and a high-intensity psychological intervention offered within 2 weeks if symptoms have not improved. [new 2014]
- 7.7.1.14.
If a woman who is taking a TCA, SSRI or (S)NRI for an anxiety disorder becomes pregnant, discuss with her the following options:
- stopping the medication gradually and switching to a high-intensity psychological intervention (for example, CBT)
- continuing with medication if she understands the risks associated with the medication and the mental health problem in pregnancy and the postnatal period and:
- -
has expressed a preference for medication, or
- -
declines psychological interventions, or
- -
her symptoms have not responded to psychological interventions.
- changing medication if there is a drug that is effective for her with a lower risk of adverse effects
- combining medication with a high-intensity psychological intervention (for example, CBT) if the woman understands the risks associated with the medication and the mental health problem in pregnancy and the postnatal period and there is no response, or a limited response, to a high-intensity psychological intervention alone. [new 2014]
Psychological interventions for eating disorders
- 7.7.1.15.
For a woman with an eating disorder in pregnancy or the postnatal period:
- offer a psychological intervention in line with the guideline on eating disorders (NICE clinical guideline 9)
- monitor the woman's condition carefully throughout pregnancy and the postnatal period
- assess the need for fetal growth scans
- discuss the importance of healthy eating during pregnancy and the postnatal period in line with the guideline on maternal and child nutrition (NICE public health guidance 11)
- advise her about feeding the baby in line with the guideline on maternal and child nutrition (NICE public health guidance 11) and support her with this. [new 2014]
Interventions for severe mental illness
- 7.7.1.16.
Consider psychological interventions for women with bipolar disorder. This includes:
- CBT, IPT and behavioural couples therapy for bipolar depression
- structured individual, group and family interventions designed for bipolar disorder to reduce the risk of relapse, particularly when medication is changed or stopped. [new 2014]
- 7.7.1.17.
Consider psychological interventions (CBT or family intervention) delivered as described in section 1.3.7 of the guideline on psychosis and schizophrenia in adults (NICE clinical guideline 178) for a woman with psychosis or schizophrenia who becomes pregnant and is at risk of relapse arising from:
- stress associated with pregnancy or the postnatal period
- a change in medication, including stopping antipsychotic medication. [new 2014]
Considerations for women and their babies in the postnatal period
Traumatic birth, stillbirth and miscarriage
- 7.7.1.18.
Offer advice and support to women who have had a traumatic birth or miscarriage and wish to talk about their experience. Take into account the effect of the birth or miscarriage on the partner and encourage them to accept support from family and friends. [new 2014]
- 7.7.1.19.
Offer women who have post-traumatic stress disorder, which has resulted from a traumatic birth, miscarriage, stillbirth or neonatal death, a high-intensity psychological intervention (trauma-focused CBT or eye movement desensitisation and reprocessing [EMDR]) in line with the guideline on post-traumatic stress disorder ( PTSD) (NICE clinical guideline 26). [new 2014]
- 7.7.1.20.
Do not offer single-session high-intensity psychological interventions with an explicit focus on ‘re-living’ the trauma to women who have a traumatic birth. [new 2014]
- 7.7.1.21.
Discuss with a woman whose baby is stillborn or dies soon after birth, and her partner and family, the option of 1 or more of the following:
- seeing a photograph of the baby
- having mementos of the baby
- seeing the baby
- holding the baby.
This should be facilitated by an experienced practitioner and the woman and her partner and family should be offered a follow-up appointment in primary or secondary care. If it is known that the baby has died in utero, this discussion should take place before the delivery, and continue after delivery if needed. [new 2014]
The mother–baby relationship
- 7.7.1.22.
Recognise that some women with a mental health problem may experience difficulties with the mother–baby relationship. Assess the nature of this relationship, including verbal interaction, emotional sensitivity and physical care, at all postnatal contacts. Discuss any concerns that the woman has about her relationship with her baby and provide information and treatment for the mental health problem. [new 2014]
- 7.7.1.23.
Consider further intervention to improve the mother–baby relationship if any problems in the relationship have not resolved. [new 2014]
7.7.2. Research Recommendations
- 7.7.2.1.
What methods can improve the identification of women at high risk of postpartum psychosis and reduce this risk?
- 7.7.2.2.
Are interventions designed to improve the quality of the mother–baby relationship in the first year after childbirth effective in women with a diagnosed mental health problem?
- 7.7.2.3.
Is structured clinical management for moderate to severe personality disorders in pregnancy and the postnatal period effective at improving outcomes for women and their babies?
- 7.7.2.4.
Are psychological interventions effective for treating moderate to severe anxiety disorders (including OCD, panic disorder, post-traumatic stress disorder and social anxiety disorder) in pregnancy?
- 7.7.2.5.
What screening tools are effective in identifying the range of eating disorders (including anorexia nervosa, bulimia, binge eating disorder and eating disordrs not otherwise specified) in pregnancy?
- 7.7.2.6.
What adaptations to current effective psychological interventions (for example, mode of delivery, duration, content, and intensity of treatment) are needed for use in the perinatal period to treat eating disorders?
Footnotes
- 11
Here and elsewhere in the guideline, each study considered for review is referred to by a study ID in capital letters (primary author and date of study publication, except where a study is in press or only submitted for publication, then a date is not used).
- 12
Adapted from the guideline on depression in adults (NICE clinical guideline 90).
- INTRODUCTION
- FACTORS TO CONSIDER IN THE EVALUATION OF PSYCHOLOGICAL AND PSYCHOSOCIAL TREATMENT
- DEFINITIONS OF PSYCHOLOGICAL AND PSYCHOSOCIAL INTERVENTIONS
- PSYCHOLOGICAL AND PSYCHOSOCIAL INTERVENTIONS FOR THE PREVENTION OF MENTAL HEALTH PROBLEMS
- PSYCHOLOGICAL AND PSYCHOSOCIAL INTERVENTIONS FOR THE TREATMENT OF MENTAL HEALTH PROBLEMS
- LINKING EVIDENCE TO RECOMMENDATIONS
- RECOMMENDATIONS
- PSYCHOLOGICAL AND PSYCHOSOCIAL INTERVENTIONS FOR THE PREVENTION OR TREATMENT OF ...PSYCHOLOGICAL AND PSYCHOSOCIAL INTERVENTIONS FOR THE PREVENTION OR TREATMENT OF MENTAL HEALTH PROBLEMS - Antenatal and Postnatal Mental Health
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- mixed-lineage leukemia-like protein 2, partial [Sebastapistes tinkhami]mixed-lineage leukemia-like protein 2, partial [Sebastapistes tinkhami]gi|469608940|gb|AGH61547.1|Protein
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