PROTOCOL VERSION 3 22/12/10 EVALUATION OF DIFFERENT LEVELS OF SUPPORT IN USING A RECOVERY GUIDE FOR PEOPLE WITH PSYCHOSIS AND THE IMPACT OF CHOICE ON OUTCOMES
Introduction
Although recent government guidelines (National Institute for Clinical Effectiveness, 2004) have recommended that people with persistent psychosis be supported using psychological intervention approaches such as cognitive–behaviour therapy, the widespread current lack of trained therapists to deliver this type of intervention means that provision of this type of intervention is likely to be limited. As a result, exploration of how this support can be provided to the greatest numbers of people is urgently needed. One way that is currently being explored within other domains is the stepped care approach first described in the United States in relation to the delivering of health care within primary care. Stepped care assumes that the least restrictive treatment or the minimum of therapist time is delivered that still brings about a significant improvement to the individual receiving it (Bower and Gilbody, 2005).
The stepped care approach has been examined in the UK in relation to the development of services for people with non-psychotic disorders. Much of this has been related to cognitive–behavioural interventions that appear to lend themselves well to a stepped care approach. For example, using CBT oriented bibliography (Cuijpers, 1997), computerised treatment (Marks et al., 2003), telephone treatment (Lovell et al., 2006) as well as face to face contact and ’full-blown’ CBT. Despite these developments within the primary care domain, little has been little explored within services for people with severe mental illness. However, these CBT approaches may well lend themselves extremely well to this client group whose ability to access ‘traditional talking treatments’ may be limited by lack of availability and by their difficulty in attending and travelling to travel to clinics.
One recent study, carried out by our group, has evaluated the applicability of one such approach with service users with psychosis. This study used a CBT oriented Recovery Guide with support from a CBT therapist delivered over the phone (over 6 months) and evaluated its impact using qualitative and quantitative methods. A comparison no intervention group was included although this was a small pilot trial, not a randomised controlled trial. Findings revealed that the approach was acceptable to the majority of participants (n = 15) and there were few drop-outs. Qualitative feedback from therapists and participants indicated that the content of the guide was relevant and that the support provided by telephone was useful and appropriate for providing support for the guide (Pitt et al., 2009). However, findings revealed that some participants would prefer different levels of support in the use of the guide, for example, some would have preferred face to face therapy support rather than delivered over the telephone.
This qualitative finding was also confirmed by other methods. A study investigating the factors contributing to service user’s preferences for levels of psychological treatment was also carried out (n = 90 Gerrard et al., 2009). Service users were presented with detailed information about the Recovery Guide and about different levels of therapy support for using the guide (low support = telephone support; high support = telephone therapy plus group support). Service users were asked to say whether they would be willing to take part in a trial involving these types of interventions, to say whether they would be willing to be randomised and to indicate whether they had a preference for treatment and is so, what treatment they would prefer (none, low support or high support) if they were to take part. Findings revealed that 90% would be willing to take part in a trial of psychological treatments although 57% of the participants said they were unwilling to be randomised. In addition, 22% said that if they were to take part they would prefer not to receive the psychological treatment. Of those who preferred treatment, 43% said they would prefer low support and 33% said they would prefer high support. These findings suggest that service users have strong preferences about the type of psychological treatments they would prefer.
These preferences have not been taken into account in previous psychological treatment trials although such preferences can make the interpretation of outcomes and their implementation in services problematic as variables related to preference may also be related to outcome (e.g. Janevic et al., 2003). First, service users may either refuse to enter trials in case they do not receive their preferred treatment, or they may drop out of trials early because they are unhappy with the condition they have been allocated. Second, people may have feel resentful and demoralised (Bradley, 1993) if they do not get their preferred treatment choice, whereas those randomised to choice may have a morale boost. Such effects make the efficacy of the actual treatments difficult to evaluate. In order to take account of patient preferences, partially randomised PPTs where patients with treatment preferences are allowed their treatment without randomisation and those who do not have preference are randomised in the usual way have been suggested (Brewin and Bradley, 1989).
Clearly there are methodological problems with PPTs, the chief being that any comparison that uses non randomised groups is potentially unreliable because of unknown confounds (e.g. differences at baseline such as previous treatment history that might influence perceptions of effectiveness of treatments offered). However, ways of reducing the impact of such problems include: performing at least one comparison of the ‘true’ randomised arms alone; collecting information on potential confounds including ascertaining reasons for choice, then adjusting for these where the analysis includes non randomised people; using randomisation status (random/non-random) as a covariate in analyses. Because of the information required about patient preferences, it is therefore important to conduct adequate assessments about patient choice prior to conducting the preference trial.
In the case of the proposed trial we would argue that the potential benefits of a PPT outweigh the methodological problems, particularly as the preparatory work on patient choice has been conducted and the adjustments suggested above are included in the design and analysis. Such benefits include the likelihood that we will be able to recruit people who would otherwise refuse to take part in a traditional RCT and thus the sample will be more representative of all service users. A PPT will also improve the external validity of the trial and will likely be more commensurate with the nature of service users seen in routine practice. Moreover, the information about patient preferences and outcomes will inform services not only about the efficacy of treatments but also about patient preferences and likely take up of alternative methods of treatment delivery.
Aims
As this is a trial which allows the participant choice about the treatment they receive, it is expected that similar impacts will be seen across all three groups in the trial regardless of whether they receive therapy or not. With this in mind, specific aims are:
To evaluate the feasibility and acceptability of the Recovery Guide (Barrowclough et al., 2009) when provided with either low or high support for people with psychosis.
To assess the relative impact of the guide in relation to low and high support and no- treatment1 on psychotic symptoms, affect, well-being and functioning.
To investigate the role of emotion and beliefs in relation to recovery.
As a result it is hypothesised that:
The Self-Help Recovery Guide will be acceptable and feasible to use by service users with psychosis as judged by retention in the treatment (assuming retention of 70%) and from qualitative interviews and this will not differ between those receiving high and low support.
There will be significant improvements in the disruption and distress caused by psychosis, affect, functioning and well-being and effect sizes will be comparable across groups (both no treatment and high and low support).
Exploratory aims also include:
To evaluate the impact of the two different modes of treatment on the working alliance between client and therapist.
To explore the relationship between change in symptoms, compassion, affect and cognitive processes associated with emotion in relation to recovery.
To explore the relationship between core schema and the experience of psychosis.
*As this is a pilot study and not a definite trial, estimates of the impact of treatment will be explored so that effect sizes can guide subject numbers required to carry out a subsequent study of effectiveness.
Method
Participants
Participants will meet the following inclusion criteria:
ICD-10 diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder or psychotic disorder (not otherwise specified).
Receiving mental health services in North West NHS trust of (insert 5 names).
Able to give informed consent.
Potential participants will be excluded if they have a primary organic disorder.
Participants who do not speak/read English will be excluded as the assessment measures, interview schedules and Recovery Guide are in English and we do not have the means to translate these.
Participants experiencing an acute exacerbation of symptoms requiring inpatient or other changes to treatment are unable to take part in the study.
Recruitment
Recruitment will take place in 4 mental health trusts and through voluntary groups within the North West of England. Within the mental health trusts, care coordinators, responsible medical officers, etc. will be provided with information about the study by the research team and will be asked to share this with potential participants. In addition, information providing sessions will be provided by the research teams to recruitment sites. If participants wish to be approached to receive more information about the research, a risk assessment will be carried out with the Care Coordinator. This assessment will then inform the best way to approach participants. They will then be approached and provided with information about the study. They will be given 24 hours to consider the information and, if they wish to proceed will be asked to sign a consent form. Once the participant has given consent, the Research Assistants will carry out an initial screen to ensure that the participant meets inclusion criteria. Participants meeting criteria will then be assessed using the battery of measures listed below. Participants will be recruited from voluntary groups using a similar procedure. Voluntary group organisations will be approached to publicise the research to their members and the project team will conduct information providing sessions. Interested members will be asked whether they would be willing to allow the research team to liaise with their Mental Health Care Coordinator (or clinical team). If yes, the Care coordinator will be approached to ensure that there is continuity between the Research Team and Clinical Services and to allow the appropriate risk assessment to be carried out. These participants will then be approached in the manner described above.
Measures
Primary outcome
Recovery: The Questionnaire Promoting Recovery from Psychosis (QPR; Neill et al., 2009) and Service User Experience of Psychosis Scale (SEPS; Haddock et al., 2009). Two self-report measures assessing different aspects of the impact of psychosis.
Secondary outcomes
Symptoms of psychosis
Positive and Negative Syndrome Schedule (positive and negative scales only; PANSS; Kay et al., 1989),
Psychotic Symptom Rating Scales (PSYRATS; Haddock et al., 1999) and recordings of symptom content. These are semistructured interviews aimed at eliciting and describing participants’ experience of psychosis
Calgary Depression Scale (Addington and Addington, 2001). This is a semistructured interview aimed at eliciting and describing participants’ experience of depression
The substance use section of The Opiate Treatment Index (OTI) (Darke et al., 1992). This is a measure of substance use severity and is in the form of a structured interview that lasts approximately 5–10 minutes.
Questions relating to contact with services:
When was your first contact with mental health services?
When was your first contact with mental health services for reasons to do with psychosis?
Emotion and emotional processes (all self-report questionnaires)
Beck Anxiety Inventory (BAI; Beck et al., 1988)
Positive Facets Scale (WHO-QOL; WHOQOL Group, 1998)
Metacognition in emotion scales (comprising scales of rumination worry, etc.)
Self-beliefs: Brief Core Schema Scales (ref) and the LeCompte Self-Esteem Scale (LeCompte et al., 2006). These are self-report questionnaires.
Compassion scale (Neff, 2003b)
Personal and Social performance Scale (PSP; Morosini et al., 2000)
Demographic questionnaire
Types of positive affect scale (Gilbert 2008).
It is anticipated that the interview based assessments will take approximately 40–45 minutes, and the questionnaires will take approximately 30 minutes to complete. All measures (1 to 6) will be administered at baseline, 9 and 15 months by an RA blind to treatment condition. In order to ensure that participants are comfortable in completing the interviews and assessments, they will be given the option of completing them over more than one session. In addition, the general scale of the PANSS will not be administered reducing the interview time for completing the symptom assessments to approximately 40 minutes rather than 1.5 hours.
Other measures
In addition, in order to assess therapeutic alliance, preference for psychological treatment and gain feedback on the experience of taking part, participants will also be asked to complete:
Interview about preference for psychological treatment (PPT). These interviews will be used to explain the options for psychological treatment and to facilitate the service user making an informed choice about what treatment they would prefer.
Working Alliance Inventory a self-report questionnaire of the therapeutic alliance completed by service users and their therapists.
Qualitative assessments of the experience of using the Self-Help Recovery Guide with Service Users and Care Coordinators.
The WAI and PPT scales will be administered by a therapist or Service User Researcher, trial manager or another worker allied to the trial who is not blind to treatment group, at a separate time to the other assessments. The PPT will be administered at baseline only and the WAI will be administered at session 3 and session 12 (where appropriate). Qualitative interviews will be carried out following the end of therapy by Service User Researchers. This aspect of the project will be guided by topic guides developed and used in piloting of the guide and by thematic analysis approaches (e.g. Braun and Clarke, 2006).
Procedure
Following recruitment, all participants will complete the above assessments (apart from the PPT and WAI scales) with an independent Research Assistant who will remain blind to treatment received. Participants will then complete the PPT scales with a therapist, service user researcher or trial manager. These scales will determine the preference they have for the type of psychological therapy they wish to receive. Once completed, if participants wish to participate in therapy they will be allocated a CBT therapist who will make initial contact to commence therapy (either low or high support; see below for details). Therapy will take place over 9 months and will consist of up to 30 sessions approximately once per week. Participants will then be followed up at 9 and 15 months by the RA blind to treatment condition and assessed using the measures described above (apart from PPT and WAI scales). Qualitative interviews will take place (n = 6–10 participants per treatment arm and 8–10 Care Coordinators) after therapy is completed. In addition, interviews with up to 8 participants form the different treatment arms and geographical locations will be conducted prior to therapy period commencement. Data will be stored on NHS or university premises in locked cabinets. All participants will be allocated a code number and records will be anonymised.
Therapy
Clients who choose to receive therapy will have the opportunity to choose whether they receive high or low support therapy.
Low support: this therapy will be delivered over 9 months and will consist of the following
Receive a copy of the Self-Help Recovery Guide (Barrowclough et al., 2009). This guide is a comprehensive self-help guide to recovery designed and written with clinicians and service users. It has been piloted in earlier work and has been shown to be acceptable and feasible for service users to use with some support.
Support for the guide will be delivered in up to 30 weekly sessions provided by a cognitive–behaviour therapist who will facilitate the participant to use the guide during telephone sessions. The CBT therapist will telephone the participant on a number of their choice and will provide help and guidance in sessions lasting approximately 45 minutes.
High support: this therapy will also be delivered over 9 months. It will consist of all the components of low support i.e. participants will receive:
A copy of the Self-Help Recovery Guide
Up to 30 telephone sessions with a CBT therapist.
However, in addition, participants will also receive additional support in the form of group sessions. These will be co-facilitated by CBT therapists and Service user researchers and will run approximately fortnightly over the 9 month period (approximately 15 sessions). The groups will provide additional guidance and support in the use of the Recovery Guide and will allow participants to meet other Service Users who are using the guide. The group sessions will consist of a mixture of information provision, discussion of topics in the guide and peer support.
Data and statistical analysis
All analyses will be carried out under the direction of Professor Graham Dunn from the Biomedical and Statistics Unit of the University of Manchester. Participants will be randomised to psychological treatment using remote randomisation by telephone administered by the Christie Hospitals Trials Unit using a randomised permuted blocks procedure. In relation to sample size, a trial of size 120 (80 in the intervention group and 40 controls) will have a power of about 85% to detect a true standardised effect size of 0.60, using an independent groups t-test with two-sided significance level of 0.05. Feasibility, acceptability and retention will be estimated by proportions of total sample with 95% confidence intervals. Impact of the interventions will be assessed using an analysis of co-variance allowing for co-variates that would have a potential confounding effect on treatment outcome when people choose their treatment of choice.
