Mindfulness Meditation Programs Versus Nonspecific Active Controls

Seven trials compared mindfulness meditation programs to nonspecific active controls for this outcome, and tended to show a small effect (Table 8, Figure 5). Five were MBSR trials, one was MBCT, and one was a modified version of MBSR. Four trials used the state trait anxiety inventory (STAI), while others used the brief symptom inventory anxiety subscale 18 or Beck anxiety inventory (BAI) scale. The five MBSR trials gave an equivalent amount of training, ranging from 23–27 hours, while the modified mindfulness trial gave 8 hours of training. The trials did not give enough information on the amount of home practice recommended or completed.

Figure 5

Relative difference between groups in the changes in measures of general anxiety, in the mindfulness versus nonspecific active control studies. Relative difference between groups in the change score. This is a relative percent difference, using the baseline (more...)

Among the trials that reported scores, a difference-in-change calculation shows that all had a 0.3–44 percent improvement post intervention (8 weeks), and a −2.3 to +6.8 percent improvement at the end of the trial (3–6 months). The trial conducted in Korea showed statistically significant results by the end of treatment, and the results reached statistical significance at the end of the study period for two other trials.

Gross et al. randomized patients with an organ transplant (n=138) to 8 weeks of MBSR or health education arms.⁵⁴ Anxiety was a primary outcome measure and it saw nonsignificant changes at 8 weeks and 6 months. Schmidt et al. randomized women with fibromyalgia (n=177) to one of three arms: (1) MBSR, (2) a nonspecific active control, or (3) a wait list.⁷⁰ The anxiety scale was a secondary outcome. The MBSR group showed a statistically significant 4.6 percent decrease in STAI trait score at 4 months (p=0.02) compared with the nonspecific active control. Gaylord et al. randomized women to an MBSR program adapted for individuals with irritable bowel syndrome (IBS) or a nonspecific active control (n=97).⁵³ The MBSR group showed a 6.8 percent change over baseline at 3 months (p=0.02). In a three-arm randomized clinical trial of women with early stage breast cancer, Henderson et al.⁵⁷ examined the effect of MBSR (n=100). They found no differences in scores of the BAI or the symptom checklist 90 (SCL-90) phobic anxiety scores, and did not report either set of scores.

Lee et al. randomized patients with anxiety disorders (n=46) recruited from a psychiatric hospital or its clinics in South Korea, to either an 8-week mindfulness-based stress management program or nonspecific active control (anxiety disorder-based education).⁶⁰ It was the only trial to use anxiety patients. The Korean meditation program did not appear to be a direct derivative of MBSR as most other trials in this review are, but shared overlapping features of mindfulness meditation. Outcome measures included both self-report measures (State-Trait Anxiety Inventory, State and Trait subscales; SCL-90 anxiety subscale; and a clinician-rated measure Hamilton psychiatric rating scale for anxiety. The trial standardized all of the self-report measures in Korean. The program provided 8 hours of training targeted towards anxiety reduction, with unspecified amount of home practice. At the end of 8 weeks of treatment, the meditation group showed a significantly greater improvement (p <.05) in all outcome measures compared with the education group, with relatively large effects (15–43 percent overall reduction on the measures compared with the education group). Of note, the trial saw the largest reduction (43 percent) on the clinician-rated Hamilton anxiety rating scale. This trial had a medium risk of bias.

Whitebird et al. randomized patients who were caregivers of family members with dementia (n=78) to either MBSR or education support group. This trial did not specify primary or secondary outcomes, but categorized anxiety as a primary focus of the study. The MBSR group showed no difference in the STAI state scores as compared with the education support group. We rated this trial as medium risk of bias. It provided 25 hours of training over 8 weeks by a trained teacher, with an average of 26.7 hours of homework completed by the participants.

Chiesa et al. randomized patients with major depression (n=18) who failed to achieve remission after at least 8 weeks of antidepressant therapy, to either MBCT or nonspecific active control. The trial found a nonsignificant 44 percent reduction in the BAI, which was a secondary outcome. We rated this trial as medium risk of bias. It provided 16 hours of training over 8 weeks by a trained and certified teacher, with unspecified home practice.

We conducted two meta-analyses, one of post-intervention outcomes at 8 weeks and one of end of study outcomes at 3–6 months (Figures 6–7). Both showed small and significant effect sizes favoring meditation, generally consistent with the difference-in-change analysis (Figure 5). Since the I² on the post-intervention meta-analysis was large and significant, we conducted a sensitivity analysis by removing the outlier trial by Lee et al. The effect size dropped to −0.24 (−0.44, −.04) with an I² of 0 percent (p=.49), and did not change our conclusions. Of note, these effect sizes do not account for the baseline differences and therefore may not be entirely consistent with the difference-in-change graphs.

Figure 6

Meta-analysis of the effects of meditation programs on anxiety with up to 12 weeks of followup. Notes: AC = Active Control; BAI = Beck Anxiety Inventory; BSI = Brief Symptom Inventory; CBGT = Cognitive Behavioral Group Therapy; HE=Health Education; MM (more...)

Figure 7

Meta-analysis of the effects of meditation programs on anxiety after 3–6 months of followup. Notes: AC = Active Control; BSI = Brief Symptom Inventory; CSM = Clinically Standardized; HE = Health Education; MBCT=Mindfulness-based Cognitive Therapy; (more...)

In summary, the Korean meditation trial used an anxious population and showed large effect sizes on all measures of anxiety. The remaining trials used diverse clinical populations; among these, two trials showed small significant effects at 3–4 months. There was general consistency among all three measures of anxiety. All seven trials had a medium risk of bias.

The strength of evidence is moderate that mindfulness meditation programs result in a small improvement in anxiety among various clinical populations when compared with a nonspecific active control. We based this rating on overall medium risk of bias, consistent findings for a small positive effect, directness of measures, and precise estimates (Table 17).

Table 17

Grade of trials addressing the efficacy of mindfulness meditation program on anxiety compared with nonspecific active controls among various populations.

Mantra Mindfulness Programs Versus Nonspecific Active Controls

Two trials of TM and one trial of another mantra meditation programs evaluated an anxiety outcome (Table 8).

Bormann et al. randomized HIV-infected adults (n=93) to a mantra meditation or an education group. The intervention was 10 weeks with a 22-week followup, and provided 7.5 hours of training and unspecified amount of home practice over 10 weeks.⁷⁵ At 10 weeks, the difference-in-change score on the STAI trait scale was 6.1 percent favoring the mantra group; however, this was not statistically significant. This difference reduced to 2.1 percent at 22 weeks. This trial had a medium risk of bias. It listed anxiety as one of seven primary outcomes.

Smith et al. randomized university students (n=100) interested in an anxiety reducing technique to either TM or a sham meditation program to match expectations, time, and attention.⁸³ This trial had 59 percent attrition and was also categorized as high risk of bias. The trial did not report on amount of meditation training given but it estimated a maximum home practice of 87.5 hours over 6 months. STAI trait score was a primary outcome, and at 6 months, the difference-in-change scores were not different between the two groups.

Paul-Labrador et al. randomized participants with stable coronary heart disease (n=103) to 16 weeks of either TM or health education.⁸¹ The STAI measured anxiety as a secondary outcome. The program provided up to 39 hours of training over 16 weeks with an unspecified amount of home practice. At 16 weeks of followup, the difference-in-change between the two groups was only 2.8 percent favoring the control, and was nonsignificant. This was a well-designed trial with a low risk of bias and relatively large sample size.

Overall, two TM trials had point estimates favoring the null, including one for which anxiety was a primary outcome. The largest and highest quality trial using cardiac patients showed no effect of TM compared with a nonspecific control trial.⁸¹ The other mantra trial among HIV patients had similarly null effects on anxiety. The difference-in-change graphs showed consistent results favoring a null effect (Figure 8). The meta-analysis of mantra meditation programs on anxiety was also nonsignificant (Figure 7).

Figure 8

Relative difference between groups in the changes in measures of general anxiety, in the mantra versus nonspecific active control/specific active control studies. Relative difference between groups in the change score. This is a relative percent difference, (more...)

The strength of evidence is low that mantra meditation programs do not have an effect on anxiety among various clinical populations when compared with a nonspecific active control. We based this rating on overall medium risk of bias, consistent findings, directness of measures, and imprecise estimates (Table 18). An evaluation of TM programs only does not change this conclusion.

Table 18

Grade of trials addressing the efficacy of mantra meditation programs on anxiety compared with nonspecific active controls among various populations.

Mindfulness Meditation Programs Versus Nonspecific Active Control

Five trials compared MBSR with a nonspecific active control (Table 9).^{53,54,57,70,72} All were rated as medium risk of bias and had sample sizes ranging from 75–137. These five trials provided between 23–27 hours of training with unclear amounts of home practice. In addition, three trials compared a modified MBSR program with a nonspecific active control.^60,61,66 These three were at medium to low risk of bias, provided 8–9 hours of training with unclear amounts of home practice, and had sample sizes ranging from 19–186. One trial compared MBCT with a nonspecific active control.⁸⁶ This trial had medium risk of bias, provided 16 hours of training with unclear amounts of home practice. These nine trials included diverse populations. Five trials used the Center for Epidemiologic Studies Depression Scale (CES-D), two used the Symptom Checklist 90 (SCL90) Depression subscale, and one used the Brief Symptom Inventory 18 depression subscale.

Henderson et al. randomized patients with early-stage breast cancer (n=100) to MBSR or a nutrition education program. They used two scales to measure depression. They found nonsignificant results on their main measure of depression, the Beck Depression Inventory (BDI), and did not report values. However, this trial measured numerous outcomes and did not correct for multiple comparisons. A difference-in-change estimate revealed a 49 percent improvement on the SCL-90 depression subscale (p<.05). Gaylord et al. randomized women with IBS (n=75) to MBSR versus a support program for women with IBS and showed no significant difference between trial arms at 2 or 3 months.⁵³ Schmidt et al. randomized women with fibromyalgia (n=109) to MBSR or nonspecific active control. The MBSR arm showed no changes at 8 weeks but showed a 12.4 percent nonsignificant improvement in the CES-D at 4 months compared with the control arm.⁷⁰ Gross et al. randomized solid organ transplant patients, post-surgery, (n=137) to MBSR versus health education. A difference-in-change calculation showed that MBSR participants had 25.8–31.8 percent reductions in the CES-D that were consistently maintained between 2–12 months. However, these changes did not reach significance (p=0.10).⁵⁴ Whitebird et al. randomized patients who were caregivers of family members with dementia (n=78) to either MBSR or education support group. This trial did not specify primary or secondary outcomes, but categorized depression as a primary focus of the study. The MBSR group showed a 29.1 and 10.6 percent reduction in CES-D scores at post intervention and 6 months, respectively, (p=.07 for overall reductions) as compared with the education support group. We rated this trial as medium risk of bias. It provided 25 hours of training over 8 weeks by a trained teacher, with an average of 26.7 hours of homework completed by the participants.

Chiesa et al. randomized patients with major depression (n=18) who failed to achieve remission after at least 8 weeks of antidepressant therapy, to either MBCT or nonspecific active control. The trial found a 51.6 percent reduction (p=.04) in the Hamilton rating scale for depression. We rated this trial as medium risk of bias. It provided 16 hours of training over 8 weeks by a trained and certified teacher, with unspecified home practice.

Three trials evaluated other mindfulness programs against a nonspecific active control. Oken et al. randomized people who take care of elderly relatives with dementia (n=19) to mindfulness meditation program or a nonspecific active control.⁶⁶ This trial found a nonsignificant 10.1 percent improvement on CES-D favoring the mindfulness group. This trial had a medium risk of bias, provided 9 hours of training over 7 weeks by a trained teacher and an unspecified amount of home practice.

Malarkey et al. randomized people, who either had or were at risk for cardiovascular disease due to elevated C-Reactive protein levels (n=186), to mindfulness meditation or nonspecific active control.⁶¹ It provided 9 hours of abbreviated MBSR training at work with approximately 18.5 hours of homework over 8 weeks. At 8 weeks, the trial found no differences between the groups, but did not provide data for comparisons of the size of effect. This trial had a low risk of bias.

Lee et al. randomized 46 patients with anxiety disorders recruited from a psychiatric hospital or its clinics in South Korea, to either an 8-week mindfulness-based stress management program or nonspecific active control group (anxiety disorder-based education).⁶⁰ The Korean meditation program did not appear to be a derivative of MBSR or MBCT as most other trials in this review are, but shared some overlapping features of mindfulness meditation. It found nonsignificant 30.3 percent reduction in the BDI and 17.4 percent reduction in SCL-90 depression scores. The trial standardized all of the self-report measures in Korean. The program provided 8 hours of training targeted towards anxiety reduction, with unspecified amount of home practice. This trial had a medium risk of bias.

In summary, these nine trials used diverse populations of patients, with only one of them overtly depressed. The difference-in-change graphs showed generally consistent findings favoring an improvement in depressive symptoms across studies. Two of the four trials in which depression was a primary outcome showed statistically significant results (Figure 9). The study by Malarkey had nonsignificant results, but also started out with much lower CES-D scores as compared with the other trials. We performed two meta-analyses, one of 2-month outcomes and the other of 3–6 month outcomes. The meta-analyses at 2 months found small and marginally nonsignificant effects of mindfulness meditation programs on depressive symptoms, while the meta-analysis at 3–6 months found small but significant effects (Figures 10 and 11). The 2-month meta-analysis also had a high I² (p=.012). These meta-analysis do not take into account the baseline differences, while the difference-in-change analysis do take the baseline differences into account.

Figure 9

Relative difference between groups in the changes in measures of depression, in the mindfulness versus nonspecific active control studies. Relative difference between groups in the change score. This is a relative percent difference, using the baseline (more...)

Figure 10

Meta-analysis of the effects of meditation programs on depression with up to 3 months of followup. Notes: AC = Active Control; BDI = Beck Depression Inventory; BSI = Beck Stress Inventory; CES-D = Center for Epidemiological Studies Depression Scale; CBGT (more...)

Figure 11

Meta-analysis of the effects of meditation programs on depression after 3–6 months of followup. Notes: AC = Active Control; BDI = Beck Depression Inventory; BSI = Beck Stress Inventory; CES-D = Center for Epidemiological Studies Depression Scale; (more...)

The strength of evidence is moderate that mindfulness meditation programs improve symptoms of depression among various clinical populations when compared with a nonspecific active control. We based this rating on overall medium risk of bias, consistent findings for a positive effect, directness of measures, and precise estimates (Table 19). However, since one trial is missing from the meta-analysis and the post-intervention I² is high, this strength of evidence warrants a cautious interpretation.

Table 19

Grade of trials addressing the efficacy of mindfulness meditation programs on symptoms of depression compared with nonspecific active controls among clinical populations.

Mantra Meditation Programs Versus Nonspecific Active Control

Three trials of TM assessed a depression outcome among cardiac patients. One trial of other mantra assessed depression as an outcome among HIV patients. We rated all three TM trials as low risk of bias and the other mantra trial as medium risk of bias. The TM studies ranged from 22–39 hours of training over 16–25 weeks, although one trial lasted on average 5.4 years with an estimated training time of 78 hours and 1,310 homework hours. The other mantra trial in HIV patients provided 7.5 hours of training over 5 weeks (Table 9).

Paul-Labrador et al. randomized 103 participants with stable coronary heart disease to 16 weeks of either TM or health education.⁸¹ The team measured depression as a secondary outcome using the Center for Epidemiologic Studies depression scale (CES-D). They provided up to 39 hours of training over 16 weeks with an unspecified amount of home practice. At 16 weeks of followup, the difference-in-change between the two groups was 19.1 percent favoring the control, and was nonsignificant. This trial had a low risk of bias.

Jayadevappa et al. randomized CHF patients (n=23) to either 3 months of TM or health education and used the CES-D scale to assess depression as a secondary outcome.⁷⁸ Post-intervention, difference-in-change point estimates were 46.1 and 49 percent at 3 and 6 months respectively. The trial reported these results as nonsignificant. This trial had a low risk of bias, and provided 22.5 hours of training over 6 months by trained and certified teachers. It recommended up to 90 hours of home practice during this time.

Schneider et al. randomized 201 patients with coronary artery disease to either TM or nonspecific active control. The study followed patients on average for 5.4 years. It found a nonsignificant 6.8 percent improvement in the CES-D score compared with control. This trial had a low risk of bias, and provided an estimated 78 hours of training over the study period by trained and certified teachers.

Bormann et al. randomized HIV-infected adults (n=93) to mantra meditation or an education group with primary outcomes related to the reduction of intrusive thoughts and improvement in QOL and well-being.⁷⁵ The intervention was 10 weeks with a 22-week followup, and provided 7.5 hours of training and unspecified amount of home practice.⁷⁵ At 10 weeks, the difference-in-change score on the center for epidemiologic studies depression scale was 1.6 percent and was not statistically significant. This difference increased to 20.1 percent at 22 weeks favoring the control (p=.07). This trial had a medium risk of bias. It listed depression as one of seven primary outcomes.

In summary, the difference-in-change graphs showed inconsistent results (Figure 12). All three of the TM trials were low risk of bias, conducted in cardiac patients, and depression was a secondary outcome. Only two of the four trials provided data to conduct a meta-analyses at 4–6 months of followup (Figure 11), showing a small nonsignificant effect size.

Figure 12

Relative difference between groups in the changes in measures of depression, in the mantra versus nonspecific active control/specific active control studies. Relative difference between groups in the change score. This is a relative percent difference, (more...)

The strength of evidence is insufficient that mantra meditation programs have an effect on symptoms of depression among cardiac and HIV populations when compared with a nonspecific active control. While two of the TM trials did not have data to be included in the meta-analysis, due to conflicting results in the difference-in-change analysis, we do not believe that data would change our conclusions. We based this rating on overall medium risk of bias, inconsistent findings, directness of measures, and imprecise estimates (Table 20).

Table 20

Grade of trials addressing the efficacy of mantra meditation program on symptoms of depression compared with nonspecific active controls among cardiac and HIV populations.

Mindfulness Meditation Programs Versus Nonspecific Active Control

Eight trials compared mindfulness meditation programs with nonspecific active controls, and evaluated stress or distress as an outcome (Table 10).^{52,53,61,65,66,72,88,89} Four used MBSR and four used an abbreviated version of MBSR. We rated two as low risk of bias, four as medium risk of bias, and two as high risk of bias. These trials involved diverse patient groups including patients suffering from IBS, lung disease, and HIV, as well as alcoholics and caregivers of family members with dementia. The trial sizes ranged from 19–186. Six trials used a measure of stress and two used a measure of distress.

Oken et al. randomized people who take care of elderly relatives with dementia (n=19) to mindfulness meditation or a nonspecific active control.⁶⁶ The purpose of this trial was to see if mindfulness meditation would decrease stress in caregivers of relatives with dementia. For inclusion, participants had to endorse greater than 9 points on the perceived stress scale (PSS). Although stress was a primary outcome, the PSS was a secondary measure for this trial. This trial found a nonsignificant 14.1 percent improvement on the PSS favoring the mindfulness meditation group. This trial had a medium risk of bias, provided 9 hours of training over 7 weeks by a trained teacher, and an unspecified amount of home practice.

Garland et al.⁵² assessed the effects of a modified MBCT for alcoholics versus a nonspecific active control on alcohol dependent adults (n=37) to assess whether mindfulness meditation could disrupt the risk chain of stress-precipitated alcohol relapse. The intervention lasted 10 weeks and did not specify information on the amount of training provided, although participants could have done a maximum of 17.5 hours of home practice over the 10 weeks. This trial had a medium risk of bias and found a statistically significant 21.2 percent reduction in the PSS favoring the mindfulness meditation group (p=.03). This trial studied mostly African American males.

Mularski et al. randomized elderly patients, predominantly men, with moderate to severe chronic obstructive pulmonary disorder (n=49) to MBBT or an active support group.⁶⁵ It found no difference in perceived stress scores between the two arms of the trial after 2 months. This trial suffered from a 42 percent attrition rate and had a high risk of bias.

Malarkey et al. randomized people, who either had or were at risk for cardiovascular disease due to elevated C-reactive protein levels (n=186), to mindfulness meditation or nonspecific active control.⁶¹ It provided 9 hours of abbreviated MBSR training at work with approximately 18.5 hours of homework over 8 weeks. At 8 weeks, the trial found no differences between the groups, but did not provide data for comparisons of the size of effect. This trial had a low risk of bias.

Gaylord et al. randomized women with IBS (n=75) to MBSR versus support program for women with IBS, and showed no significant difference (3.6 percent favoring MBSR) between trial arms at 2 months on the BSI 18.⁵³ At 6 months this had increased slightly to 5.2 percent (p=.049). The trial provided 23 hours of training and unspecified amount of home practice. It had a medium risk-of-bias.

Whitebird et al. randomized patients who were caregivers of family members with dementia (n=78) to either MBSR or education support group. This trial did not specify primary or secondary outcomes, but categorized stress/distress as a primary focus of the study. The MBSR group showed a 19.3 and 12.7 percent reduction in perceived stress scores at post intervention and 6 months respectively (p=.01 for overall reductions), as compared with the education support group. This trial provided 25 hours of training over 8 weeks by a trained teacher, with an average of 26.7 hours of homework completed by the participants. It had a medium risk of bias.

Seyedalinaghi et al. randomized HIV positive patients in Iran to MBSR or nonspecific active control (n=171). The trial did not specify primary or secondary outcomes, but stress/distress was a primary focus of the study. This trial provided approximately 25 hours of training over 8 weeks by trained teaches, and unspecified amount of homework, and had a high risk of bias. The trial found a 11 percent improvement in the SCL-90 revised at the end of the intervention, and a 4.9 percent worsening at 12 months compared with control. The overall effect was significant at p<.001.

Pbert et al. randomized asthmatics to MBSR or education control (n=82), and found 16.2 percent (p=.055) and 26 percent (p=.001) improvement at 10 weeks and 12 months, respectively. The trial provided 26 hours of training over 8 weeks with approximately 24 hours of recommended home practice, and did not provide information about the teachers. It had a low risk of bias.

The difference-in-change graphs generally showed consistent effects on measures of stress and distress favoring a reduction in the mindfulness groups (Figure 13). The effect size calculations included six trials and excluded two (Figure 14). However, we felt an overall meta-analysis of this data would be biased since the largest included trial⁸⁹ had a high risk of bias and carried nearly 40 percent of the statistical weight, while an even larger trial with null results that had a low risk of bias was excluded.⁶¹ Therefore, we did not present an overall effect size. Because the largest (and lowest risk-of-bias) trial by Malarkey et al.⁶¹ was inconsistent with the others trials on stress/distress, we rate the overall evidence as inconsistent. In the absence of an overall effect size, we rate the precision of the group of studies as precise due to the majority of trials (5 of 8) finding statistically significant results.

Figure 13

Relative difference between groups in the changes in measures of stress/distress, in the mindfulness versus nonspecific active control studies. Relative difference between groups in the change score. This is a relative percent difference, using the baseline (more...)

Figure 14

Meta-analysis of the effects of meditation programs on stress/distress with up to 16 weeks of followup. Notes: AC = Active Control; AE = Aerobic Exercise; ASG = Alcohol Dependence Support Group; BSI = Beck Stress Inventory; CBGT = Cognitive Behavioral (more...)

The strength of evidence is low that mindfulness meditation programs result in a small improvement in stress and distress among various clinical populations when compared with a nonspecific active control. We based this rating on overall medium risk of bias, inconsistent findings, directness of measures, and precise estimates (Table 21).

Table 21

Grade of trials assessing the efficacy of mindfulness programs on stress and distress compared with nonspecific active controls among various populations.

Mantra Meditation Programs Versus Nonspecific Active Control

Three trials of mantra meditation programs evaluated stress as an outcome for cardiac patients (Table 10). Two were TM and one used another mantra meditation program. Both TM trials studied cardiac patients and both had a low risk of bias. One used the Life Stress Instrument Questionnaire and the other used the PSS. The other mantra meditation trial studied HIV patients and used the PSS.

Paul-Labrador et al. randomized patients with stable coronary heart disease (n=103) to 16 weeks of either TM or health education.⁸¹ Stress was a secondary outcome measured by the Life Stress Instrument Questionnaire. The program provided up to 39 hours of training over 16 weeks with an unspecified amount of home practice. At 16 weeks of followup, the difference-in-change between the two groups was 5.9 percent favoring the control, and was nonsignificant. This trial had a low risk of bias.

Jayadevappa et al. randomized CHF patients (n=23) to either 3 months of TM or health education, assessing stress as a secondary outcome using the PSS scale.⁷⁸ With 100 percent trial completion and a 95 percent compliance rate among the originally randomized subjects, there was no difference in perceived stress scores between the two groups at 3 or 6 months. Difference-in-change point estimates were 0.9 and 1.3 percent at 3 and 6 months, respectively. These were reported as nonsignificant. This trial provided 22.5 hours of training over 6 months by trained and certified teachers and recommended up to 90 hours of home practice during this time. It had a low risk of bias.

Bormann et al. randomized adults with HIV (n=93) to mantra meditation or an education group with primary outcomes related to the reduction of intrusive thoughts and improvement in QOL and well-being.⁷⁵ The intervention was 10 weeks with a 22-week followup, and provided 7.5 hours of training and unspecified amount of home practice over 10 weeks.⁷⁵ The difference-in-change score on the PSS was 1.2 and 3 percent at 10 and 22 weeks, respectively, favoring the null, and was not statistically significant. This trial had a medium risk of bias. Stress was one of seven primary outcomes.

The difference-in-change graphs showed consistent findings of a null effect of mantra meditation programs on stress (Figure 15). A meta-analysis of two of the trials suggested a small nonsignificant effect (Figure 14).

Figure 15

Relative difference between groups in the changes in measures of stress, in the mantra versus nonspecific active control studies. Relative difference between groups in the change score. This is a relative percent difference, using the baseline mean in (more...)

The strength of evidence is low that mantra meditation programs have no effect on stress when compared with a nonspecific active control. We based this rating on overall medium risk of bias, consistent findings of a null effect, directness of measures, and imprecise estimates (Table 22).

Table 22

Grade of trials addressing the efficacy of mantra meditation programs on stress compared with nonspecific active controls among cardiac and HIV patients.

Mindfulness Meditation Programs Versus Nonspecific Active Control

Thirteen trials compared mindfulness meditation programs with nonspecific active controls, and evaluated a negative affect outcome (Table 11). Since some trials reported on more than one outcome, for these trials we prioritized anxiety over depression and depression over stress/distress as indirect measures of negative affect. None of the trials used a direct measure of negative affect. Seven trials reported on anxiety, two on depression, and four on stress/distress. The trials included diverse populations, ranging in sample size from 18–186. Two trials had a low risk of bias, nine had a medium risk of bias, and two had a high risk of bias. For five of the trials the outcome was a primary outcome. We previously described these trials, and displayed them in graphical form in Figure 16. The difference-in-change graphs showed a consistent improvement in negative affect when we compared mindfulness meditation programs to a nonspecific active control. Two trials showed small nonsignificant effects, which became significant at the end of study, and four trials showed significant effects post-intervention. A meta-analysis of these trials showed a small statistically significant effect size of 0.34 favoring meditation (Figure 17). We conducted a sensitivity analysis reversing our prioritization order, prioritizing stress/distress over depression and depression over anxiety, to see if this would change our conclusions (Figures 18–19). Both analyses gave similar results.

Figure 16

Relative difference between groups in the changes in negative affect, in the mindfulness versus nonspecific active control studies. Relative difference between groups in the change score. This is a relative percent difference, using the baseline mean (more...)

Figure 17

Meta-analysis of the effects of meditation programs on negative affect—main analysis (mindfulness meditation versus nonspecific active control interventions). Notes: AC = Active Control; ASG = Alcohol Dependence Support Group; BAI=Beck Anxiety (more...)

Figure 18

Relative difference between groups in the changes in measures of negative affect, in the mindfulness versus nonspecific active control studies (sensitivity analysis). Relative difference between groups in the change score. This is a relative percent (more...)

Figure 19

Meta-analysis of the effects of meditation programs on negative affect—sensitivity analysis (mindfulness meditation versus nonspecific active control interventions). Notes: AC = Active Control; ASG = Alcohol Dependence Support Group; BSI = Beck (more...)

The strength of evidence is low that mindfulness meditation program improve negative affect among various clinical populations when compared with a nonspecific active control. We based this rating on overall medium risk of bias, consistent results, indirect measures of negative affect, and precise estimates (Table 23).

Table 23

Grade of trials addressing the efficacy of mindfulness meditation programs on negative affect compared with nonspecific active controls among diverse populations.

Mantra Meditation Programs Versus Nonspecific Active Control

Five trials compared mantra meditation programs with nonspecific active controls, and evaluated a negative affect outcome (Table 11). Four were TM trials and one was other mantra meditation program. Three trials reported on anxiety and two on depression. The difference-in-change graphs show inconsistent results (Figure 20). We conducted a sensitivity analysis reversing the order of prioritization, prioritizing stress/distress over depression and depression over anxiety, to see if this would change our conclusions. The difference-in-change graph now showed consistently null results (Figure 21). A meta-analysis of the main outcomes for negative affect among mantra studies only replicated the anxiety meta-analysis (Figure 7) due to missing data on two of the trials that had a depression outcome. The meta-analysis of the sensitivity analysis showed a small nonsignificant overall effect (Figure 22).

Figure 20

Relative difference between groups in the changes in measures of negative affect, in the mantra versus nonspecific active control studies. Relative difference between groups in the change score. This is a relative percent difference, using the baseline (more...)

Figure 21

Relative difference between groups in the changes in measures of negative affect, in the mantra versus nonspecific active control studies (sensitivity analysis). Relative difference between groups in the change score. This is a relative percent difference, (more...)

Figure 22

Meta-analysis of the effects of mantra meditation programs on negative affect—sensitivity analysis (mantra vs. nonspecific active control interventions). Note: AC = Active Control; HE=Health Education; GA = General Anxiety; mos = months; PSS = (more...)

The strength of evidence is insufficient that mantra programs have an effect on negative affect among various clinical populations when compared with a nonspecific active control. We based this rating on overall medium risk of bias, inconsistent results, indirect measures of negative affect, and imprecise estimates (Table 24).

Table 24

Grade of trials addressing the efficacy of mantra meditation programs on negative affect compared with nonspecific active controls among diverse populations.

Mindfulness Meditation Programs Versus Nonspecific Active Control

Three trials compared mindfulness meditation programs with nonspecific active controls, and evaluated positive affect as an outcome. They used differing populations, included a range of 18–137 patients, and were all of medium risk of bias (Table 12).

Henderson et al. randomized women with early-stage breast cancer (n=100) to MBSR or nonspecific active control.⁵⁷ The study used the Sense of Coherence Meaningfulness Subscale to measure subjective well-being as a secondary endpoint. At 4 months there was a statistically significant 6.8 percent improvement in mean Sense of Coherence Meaningfulness Subscale scores in the MBSR group as compared with the control group (p <0.05). However, this trial measured numerous outcomes and did not make any corrections for multiple comparisons. This trial had a medium risk of bias, provided 25 hours of training over 8 weeks, and did not specify whether it recommended home practice or not.

Gross et al. randomized solid organ transplant patients, post-surgery, (n=137) to MBSR versus health education.⁵⁴ The study used the Short Form-36 (SF-36) vitality score to measure improvement in positive mood as a secondary outcome. There were no differences between the groups at end of treatment. This trial provided 27 hours of training by a trained teacher, and unspecified amount of home practice over 8 weeks.

Chiesa et al. randomized patients with major depression (n=18) who failed to achieve remission after at least 8 weeks of antidepressant therapy, to either MBCT or nonspecific active control. The trial found a 54.6 percent reduction (p=.05) in the Psychological General Well-being Index. This trial had a medium risk of bias. It provided 16 hours of training over 8 weeks by a trained and certified teacher and had unspecified home practice.

Overall, the difference-in-change graphs show a small consistent effect of the mindfulness meditation programs on positive mood with one trial showing a small significant effect that diminishes with time, and another trial showing a large significant effect (Figures 23–24).

Figure 23

Relative difference between groups in the changes in measures of positive affect, in the mindfulness versus nonspecific active control/specific active control studies. Relative difference between groups in the change score. This is a relative percent (more...)

Figure 24

Meta-analysis of the effects of meditation programs on positive affect with up to 4 months of followup. Notes: AE = Aerobic Exercise; HE = Health Education; HLC = Healthy Living Course; HAM-D = Hamilton Psychiatric Rating Scale for depression; MBSR = (more...)

The strength of evidence is insufficient that mindfulness meditation program have an effect on positive affect when compared with a nonspecific active control. We based this rating on medium risk of bias, consistent findings, indirect measures, and imprecise estimates (Table 25).

Table 25

Grade of trials addressing the efficacy of mindfulness meditation programs on positive affect compared with nonspecific active controls among organ transplant recipients and breast cancer patients.

Transcendental Meditation Versus Nonspecific Active Control

Jayadevappa et al. randomized CHF patients (n=23) to either 3 months of TM or health education, assessing positive mood as a secondary outcome using the SF-36 vitality subscale.⁷⁸ With 100 percent trial completion and a 95 percent compliance rate among the originally randomized subjects, this trial found no differences at 3 and 6 months (Figure 25). This trial had a low risk of bias, and provided 22.5 hours of training over 6 months by trained and certified teachers. It recommended up to 90 hours of home practice during this time (Table 12).

Figure 25

Relative difference between groups in the changes in measures of positive affect, in the mantra versus nonspecific active control studies. Relative difference between groups in the change score. This is a relative percent difference, using the baseline (more...)

The strength of evidence is insufficient about the effects of TM on positive affect when compared with a nonspecific active control. We based this rating on a single low risk-of-bias study, unknown consistency, indirect measures, and imprecise estimates (Table 26).

Table 26

Grade of trials addressing the efficacy of transcendental meditation on positive affect compared with nonspecific active controls among cardiac patients.

Mindfulness Meditation Programs Versus Nonspecific Active Control

Pbert et al. randomized asthmatics to MBSR or education control (n=82), and specified asthma QOL as a primary outcome. It found a 6.2 percent (ns) and 26 percent (p=.002) improvement at 10 weeks and 12 months, respectively, in the emotional function domain of asthma quality of life. The trial provided 26 hours of training over 8 weeks with approximately 24 hours of recommended home practice, and had a low risk of bias. There was no information about the teachers (Table 13).

Whitebird et al. randomized patients who were caregivers of family members with dementia (n=78) to either MBSR or education support group. This trial did not specify primary or secondary outcomes, but the short form-12 (SF-12) mental component score was categorized as a primary focus of the study. The MBSR group showed a 28.4 and 24.3 percent reduction in perceived stress scores post-intervention and 6 months, respectively, (p<.001 for overall reductions) as compared with the education support group. This trial had a medium risk of bias, provided 25 hours of training over 8 weeks by a trained teacher, and had an average of 26.7 hours of homework completed by the participants.

Gross et al. randomized solid organ transplant patients, post-surgery, (n=137) to MBSR versus health education.⁵⁴ The trial used the SF-12 mental component score to measure improvement in the mental component of health-related QOL as a secondary outcome. There were no differences between the groups at end of treatment (p=.29). This trial provided 27 hours of training by a trained teacher, and had an unspecified amount of home practice over 8 weeks. This trial had medium risk of bias.

Mularski et al. randomized elderly patients, predominantly men, with moderate to severe chronic obstructive pulmonary disorder (n=49) to a mindfulness-based breathing therapy or a support group.⁶⁵ The trial used the Veterans Rand-36 to measure QOL as a secondary outcome. There was a nonsignificant 8.3 percent improvement in the Veterans Rand-36 scores in the MBBT group after 2 months. This trial suffered from a 42 percent attrition rate and had a high risk of bias.

The difference-in-change graphs suggested a small improvement for mindfulness meditation programs in the mental component of QOL when compared with nonspecific active controls (right side of Figure 26). The meta-analysis suggests a small nonsignificant effect (Figure 30)

Figure 26

Relative difference between groups in the changes in measures of mental component of health-related quality of life, in the mindfulness versus nonspecific active control/specific active control studies. Relative difference between groups in the change (more...)

Figure 30

Meta-analysis of the effects of meditation programs on the mental health component of health-related quality of life with up to 3 months of followup. Notes: HE = Health Education; HLC = Healthy Living Course; MBSR = Mindfulness Based Stress Reduction; (more...)

The strength of evidence is low that mindfulness meditation programs improve the mental component of health-related QOL in various patients as compared with a nonspecific active control. We based this rating on overall medium risk of bias, consistent findings, direct measures, and imprecise estimates (Table 27).

Table 27

Grade of trials addressing the efficacy of mindfulness meditation programs on the mental component of health-related quality of life compared with nonspecific active controls among various patients.

Mindfulness Meditation Programs Versus Specific Active Control

Nine trials evaluated a mindfulness meditation program against a specific active control for the outcome of anxiety (Table 8). Six trials used MBSR, one used MBCT, and two used mindfulness meditation. The control groups were heterogeneous including medications, spirituality interventions, exercise, and group therapies. Sample sizes ranged from 25–110. Two trials had a high risk of bias, five had a medium risk of bias, and two had a low risk of bias.

Wong et al.⁷⁴ randomized Chinese-speaking participants with chronic pain (n=99) to an 8-week MBSR program or a multidisciplinary pain intervention. The trial saw nonsignificant changes at 2 and 6 months post-intervention in the STAI state and trait scores. The profile of mood states (POMS) tension difference-in-change score showed the greatest change (11.5 percent) favoring MBSR, but was also nonsignificant.

Gross et al. randomized adults with primary chronic insomnia (n=30) to an 8-week MBSR program or an 8-week course of pharmacotherapy with eszopiclone.⁵⁵ At 2 and 5 months post-intervention, there were no significant changes in STAI state or trait scores in either group, but the directionality of difference-in-change point estimates favored the MBSR group.

Moritz et al. randomized people with mood disorders (n=165) recruited from primary care clinics to 8 weeks of either MBSR or an 8-week audio taped spirituality home trial program.⁶³ This trial evaluated the superiority of a spirituality program to MBSR, as opposed to other trials, using a comparative effectiveness design. MBSR was used as the control. They utilized a POMS score of 40 or greater as inclusion criteria, indicating a moderate degree of mood disturbance, and as a main outcome measure. Although groups appeared matched for amount of training (12 hours over 8 weeks), the spirituality group received up to 42 hours of home practice over that time and it is unclear whether the MBSR group received the same. At 8 weeks, the difference in the MBSR group from baseline was 39 percent lower than that in the spirituality group (p=0.007).

Koszycki et al.⁵⁸ randomized patients with generalized social anxiety disorder (n=53) to an 8-week course of MBSR or a 12-week course of group cognitive behavior therapy. MBSR received a maximum of 27.5 hours of training and a maximum of 28 hours of home practice over 8 weeks. Outcome measures included four scales of social anxiety, which favored group cognitive behavior therapy over MBSR: Liebowitz social anxiety-fear scale (p=.09), social anxiety-avoidance scale (p=.009), social phobia scale (p=.006), and social interaction scale (p=.057). Although the groups cognitive behavior therapy group ran for 4 weeks longer than MBSR, the total dose was similar (27.5 hours of training for MBSR vs. 30 hours for group cognitive behavior therapy). It remains unclear if it was the effect of the training over a longer period of time in the group cognitive behavior therapy arm that accounted for the differences. The analysis appeared to compare post-treatment scores only, and it was unclear whether they accounted for baseline differences in the analysis, given that there were large baseline differences between the groups.

Barrett et al.⁸⁵ randomized patients with a history of upper respiratory infections to MBSR or exercise (n=98). The trial provided about 20 hours of training by trained teachers, and approximately 42 hours of recommended homework over the 8-week training period. The STAI state score was a secondary outcome. The trial found no significant differences between the two arms.

Jazaieri et al.⁸⁷ randomized patients with social anxiety disorder to MBSR or exercise (n=56). The trial provided about 25 hours of training by trained teachers, and their participants performed an average of 28.3 hours of homework over the 8-week training period. Although they did not specify primary or secondary outcomes, the study characterized the Liebowitz social anxiety scale as a primary outcome since it was a primary focus of the study. The trial found a nonsignificant improvement of 6.2 percent, which worsened over time in the MBSR group as compared with exercise. This trial had a high risk of bias.

Philippot et al. randomized patients with tinnitus (n=30) to a 6-week modified MBCT program or progressive muscular relaxation training.⁶⁷ This trial used the STAI (unspecified) and found no statistically significant differences between-groups. It provided 13.5 hours of training and an unspecified amount of home practice. We rated it as medium risk of bias.

Delgado et al. randomized worriers (n=36) to 5 weeks of mindfulness meditation or progressive muscular relaxation, providing 10 hours of training and unspecified amount of home practice.⁵¹ They found no significant differences in the STAI trait score, and had a medium risk of bias. Piet et al. randomized 26 patients with social phobia to MBCT or group cognitive behavior therapy.⁶⁸ They provided 16 hours of training and up to 28 hours of home practice over an 8-week period. This trial found no difference between the groups on the BAI However, the cognitive behavior therapy group was provided nearly double the amount of group training, 28 hours over 14 weeks, and this increased time and attention in the control group may not allow appropriate comparisons between the groups. This trial had a medium risk of bias.

The difference-in-change graphs showed inconsistent results (Figure 27). A meta-analysis of these trials showed nonsignificant effects around the null at end of treatment and end of study time points (Figures 6 and 7).

Figure 27

Relative difference between groups in the changes in measures of general anxiety, in the mindfulness versus specific active control studies. Relative difference between groups in the change score. This is a relative percent difference, using the baseline (more...)

The strength of evidence is insufficient that mindfulness meditation programs have an effect on anxiety among various clinical populations when compared with a variety of specific active controls. We based this rating on overall medium risk of bias, inconsistent findings, directness of measures, and imprecise estimates (Table 28).

Table 28

Grade of trials addressing the efficacy of mindfulness meditation programs on anxiety compared with specific active controls among diverse populations.

Other Mantra Meditation Versus Specific Active Control

Lehrer et al. assigned anxious participants to clinically standardized meditation (n=23) or progressive muscular relaxation (n=19).⁷⁹ The program provided 7.5 hours of training and unspecified amount of home practice over 5 weeks (Table 8). Undergraduate and graduate students, with 4 months of training in the technique and no prior teaching experience, provided the training. Results on all four anxiety measures favored the progressive muscular relaxation group over the clinically standardized meditation group. For measures it used institute for personality and ability testing anxiety inventory, symptom checklist 90 anxiety subscale, and state trait anxiety index state and trait scales. At 6 weeks the differences were all nonsignificant, but ranged from 6–21 percent favoring the progressive muscular relaxation group (Figure 8).

The strength of evidence is insufficient about the effects of clinically standardized meditation on anxiety in an anxious population when compared with progressive muscular relaxation. We based this rating on a single study with medium risk of bias, unknown consistency, directness of measures, and imprecise estimates (Table 29).

Table 29

Grade of trials addressing the efficacy of clinically standardized meditation programs on anxiety compared with progressive muscle relaxation among anxious participants.

Mindfulness Meditation Programs Versus Specific Active Control

Eleven trials evaluated a mindfulness meditation programs against a specific active control for the outcome of depression (Table 9). Five trials compared MBSR to various specific active controls in diverse populations. Four trials compared MBCT to either antidepressant among depressed patients, cognitive behavior therapy among anxious patients, or progressive muscle relaxation among those suffering from tinnitus. One trial compared a mindfulness meditation program to progressive muscular relaxation and one trial compared a mindfulness meditation program to viniyoga. Four trials had a low risk of bias, five had a medium risk of bias, and two had a high risk of bias. Sample sizes ranged from 25–186.

Wong et al. randomized patients with chronic pain (n=99) in Hong Kong to MBSR or a multidisciplinary pain intervention.⁷⁴ The study used two scales to assess depression. It found a nonsignificant 10.7 percent improvement on the POMS-depression at 2 months, which maintained to 6 months. However, it found no difference in the Center for Epidemiologic Studies depression scale at 2 or 6 months. This trial had a low risk of bias, provided 27 hours of training, and an unspecified amount of home practice over 8 weeks. Its teachers were trained and had 5 years of experience teaching meditation.⁷⁴

Gross et al. randomized people with insomnia (n=27) to MBSR or eszopiclone.⁵⁵ They found a 25.4 percent change in Center for Epidemiologic Studies depression scale favoring the drug at the end of 2 months, which increased to 42.2 percent at 5 months. Although these appeared to be large effects, the study reported the differences as not significant. This trial provided 26 hours of training and up to 36 hours of home practice over 8 weeks.

Koszyki et al. randomized patients with social anxiety disorder (n=53) to MBSR or group cognitive behavior therapy. The trial had a high risk of bias. They found a nonsignificant 5.3 percent difference favoring the cognitive behavior therapy group on the BDI II.⁵⁸

Moritz et al. randomized patients with mood disorders (n=110) to a spirituality program versus MBSR.⁶³ In this trial, MBSR was the active control for the spirituality intervention. The spirituality intervention included a meditative component. It provided about 12 hours of training in both interventions over an 8-week period, with unspecified amount of home practice in the MBSR group. It provided up to 42 hours of home practice in the spirituality group. There was no information on teacher qualifications for MBSR. There was a significant 31.7 percent improvement on the POMS-depression scale in the spirituality program as compared with MBSR (p<0.013). This trial had a low risk of bias.

Jazaieri et al.⁸⁷ randomized patients with social anxiety disorder to MBSR or exercise (n=56). The trial provided about 25 hours of training by trained teachers, and their participants performed an average of 28.3 hours of homework over the 8-week training period. Although they did not specify primary or secondary outcomes, the study identified depression as a primary focus of the study. The trial found nonsignificant improvements of 22.8 and 14.2 percent at 8 weeks and 5 months, respectively, in the MBSR group as compared with exercise. The trial had a high risk of bias.

Segal et al. randomized depressed patients in acute remission to MBCT with tapering of antidepressant or maintenance antidepressant medication (n=53) to assess depression relapse. Relapse rates by 600 days were 46 percent for the antidepressant group and 38 percent for MBCT. This absolute 8 percent difference did not reach statistical significance. This trial had a low risk of bias. It provided 23 hours of training by trained and certified teachers, and recommended an unspecified amount of home practice.⁷¹

Kuyken et al. randomized patients with recurrent depression (n=123) who were in full or partial remission to either maintenance anti-depressant medication or MBCT with support to taper medication.⁵⁹ After 15 months, 60 percent of the antidepressant group had relapsed as compared with 47 percent in the MBCT group. This 13 percent absolute difference did not reach statistical significance. They also measured the Hamilton depression rating scores, which were 31.7 percent lower in the MBCT group at 3 months and 26.7 percent lower at 15 months (p=.02). On a third measure, the BDI II, the MBCT group showed a 14.6 percent reduction at 3 months and 15 percent reduction at 15 months compared with the antidepressant group. These differences did not reach statistical significance. Of note, 75 percent of the MBCT had discontinued their antidepressant by 6 months. This was a low risk-of-bias trial. It provided 24 hours of training and recommended up to 37.5 hours of home practice over an 8-week period. The teachers were trained and certified.

Piet et al. randomized young adults with social phobia (n=26) to either MBCT or group cognitive behavioral therapy in a crossover design with participants receiving both treatments.⁶⁸ We evaluated comparisons after the first intervention period only, before any crossover. They provided 16 hours of training and up to 28 hours of home practice over an 8-week period. This trial found a 24.3 percent nonsignificant change favoring the cognitive behavioral therapy group on the BDI-II. However, the cognitive behavioral therapy group received nearly doubles the amount of group training, 28 hours over 14 weeks, and this increased time and attention in the control group may not allow equivalent comparisons between the groups. This trial had a medium risk of bias.

Philippot et al. randomized patients with tinnitus (n=25) to a 6-week modified MBCT program or progressive relaxation training.⁶⁷ This trial used the BDI and found an insignificant 8.7 percent differences between groups at 6 weeks favoring mindfulness meditation. At 18 weeks this effect disappeared. This trial had a medium risk of bias and provided 13.5 hours of training with an unspecified amount of home practice.

Delgado et al. randomized female university students (n=32) who were worriers to 5 weeks of mindfulness meditation or progressive muscular relaxation, providing 10 hours of training and unspecified amount of home practice.⁵¹ The study found a nonsignificant 13.3 percent improvement in the BDI in the mindfulness meditation group as compared with progressive muscular relaxation. This trial had a medium risk of bias.

Wolever et al. randomized stressed employees (n=186) to a mindfulness-at-work program or viniyoga for 12 weeks. Participants received 14 hours of training by trained teachers and unspecified amount of homework. Depression was a secondary outcome. The trial found a nonsignificant 8.5 percent improvement in the mindfulness group compared with control. This trial had a medium risk of bias.

The difference-in-change graphs show significant inconsistency (Figure 28). Two meta-analyses of results at the end of treatment and end of study show small nonsignificant effects slightly favoring meditation (Figures 10 and 11).

Figure 28

Relative difference between groups in the changes in measures of depression, in the mindfulness versus specific active control studies. Relative difference between groups in the change score. This is a relative percent difference, using the baseline (more...)

The strength of evidence is insufficient that mindfulness meditation programs have an effect on depressive symptoms among various clinical populations compared with a variety of specific active controls. We based this rating on overall medium risk of bias, inconsistent results, direct measures, and imprecise estimates (Table 30).

Table 30

Grade of trials addressing the efficacy of mindfulness meditation programs on depressive symptoms compared with specific active controls among diverse populations.

Other Mantra Meditation Versus Specific Active Control

Lehrer et al. assigned anxious participants to clinically standardized meditation or progressive muscular relaxation (n=42).⁷⁹ The program provided 7.5 hours of training and an unspecified amount of home practice over 5 weeks (Table 9). The trainers were undergraduate and graduate students with 4 months of training in the technique and no prior teaching experience. symptom checklist-90 depression scores favored the progressive muscular relaxation group over the clinically standardized meditation group. The difference-in-change scores were all nonsignificant, but ranged from 27.8 percent at 6 weeks to 7.8 percent at 6 months favoring the progressive muscular relaxation group (Figure 12).

The strength of evidence is insufficient that clinically standardized meditation has an effect on depressive symptoms in an anxious population compared with progressive muscular relaxation. We based this rating on a single study with medium risk of bias, unknown consistency, direct measures, and imprecise estimates (Table 31).

Table 31

Grade of trials addressing the efficacy of clinically standardized meditation programs on depression compared with progressive muscle relaxation among anxious participants.

Mindfulness Meditation Programs Versus Specific Active Control

Six mindfulness trials evaluated stress/distress as an outcome among populations with some form of emotional distress (Table 10). Delgado et al. randomized female university students (n=32) who had high scores on the Penn State worry questionnaire to 5 weeks of mindfulness meditation or progressive muscular relaxation, providing 10 hours of training and unspecified amount of home practice.⁵¹ Scores on the positive and negative affect scale-negative mood were a primary focus of the trial, and were relatively unchanged at 5 weeks of intervention, and there was no difference between the two groups at the end of treatment. This trial had a medium risk of bias.

Moritz et al. randomized patients with mood disorders (n=110) to a spirituality program versus MBSR.⁶³ In this trial, MBSR was the active control. It provided about 12 hours of training in both interventions over an 8-week period. It provided up to 42 hours of home practice in the spirituality group and an unspecified amount of home practice in the MBSR group. There was no information on teacher qualifications for MBSR. This trial used two scales that assessed distress, which was a primary outcome for the trial. They found a 23.8 percent change favoring spirituality at 8 weeks (p=.034) on the POMS total mood disturbance score, and a 22.4 percent change favoring spirituality at 8 weeks (p=.0.34) on the SF-36 mental health subscale score. This trial had a low risk of bias. It is notable that this intervention included a meditative component, as well as breathing exercises that may resemble features of MBSR.

Piet et al. randomized young adults with social phobia (n=26) to MBCT or group cognitive behavioral therapy in a crossover design with participants receiving both treatments.⁶⁸ We evaluated comparisons after the first intervention period only, before any crossover. They provided 16 hours of training and up to 28 hours of home practice over an 8-week period. This trial found a 13.2 percent nonsignificant change favoring the cognitive behavior therapy group on the symptom checklist 90 global severity index. However, the cognitive behavior therapy group received nearly twice the amount of group training, 28 hours over 14 weeks, and this increased time and attention in the control arm may not allow equivalent comparisons between the groups. This trial had a medium risk of bias.

Jazaieri et al.⁸⁷ randomized patients with social anxiety disorder to MBSR or exercise (n=56). The trial provided about 25 hours of training by trained teachers, and their participants performed an average of 28.3 hours of homework over the 8-week training period. Although they did not specify primary or secondary outcomes, stress was identified as a primary focus of the study. The trial found a nonsignificant improvement of 17.6 percent in the perceived stress scale at 8 weeks in the MBSR group as compared with exercise. This trial had a high risk of bias.

Barrett et al.⁸⁵ randomized patients with a history of upper respiratory infections to MBSR or exercise (n=98). The trial provided about 20 hours of training by trained teachers, and approximately 42 hours of recommended homework over the 8-week training period. The perceived stress scale was a secondary outcome. The trial found no significant differences between the two arms. This trial was rated as medium risk of bias

Wolever et al. randomized stressed employees (n=186) to a mindfulness at work program or viniyoga for 12 weeks. Participants received 14 hours of training by trained teachers and unspecified amount of homework. Perceived stress was a primary outcome. The trial found no significant differences in the mindfulness group compared with control. This trial had a medium risk of bias.

The difference-in-change graphs showed inconsistent results (Figure 29). A meta-analysis suggested a nonsignificant null effect (Figure 14).

Figure 29

Relative difference between groups in the changes in measures of distress, in the mindfulness versus specific active control studies. Relative difference between groups in the change score. This is a relative percent difference, using the baseline mean (more...)

The strength of evidence is insufficient that mindfulness meditation programs affect improve distress among those with mood disturbance or symptoms of anxiety compared with a variety of specific active controls. We based this rating on overall medium risk of bias, inconsistent results, direct measures, and imprecise estimates (Table 32).

Table 32

Grade of trials addressing the efficacy of mindfulness meditation programs on distress compared with specific active controls among populations with emotional distress.

Mindfulness Meditation Programs Versus Specific Active Control

Four trials evaluated the effect of mindfulness meditation programs compared with a specific active control on the outcome of positive affect (Table 12). Delgado et al. randomized female students (n=32) with high scores on the Pittsburgh sleep quality index (PSQI) to 5 weeks of either mindfulness training or progressive muscle relaxation training, providing 10 hours of training and unspecified amount of home practice.⁵¹ The trial did not detect any within or between-group effects on the positive and negative affect schedule. This trial had a medium risk of bias.

Moritz et al. randomized patients with mood disorders (n=110) to a spirituality program versus MBSR.⁶³ In this trial, MBSR was the active control for the spirituality intervention they were testing. The trial selected participants with high scores on the POMS scale. The spirituality program had meditative components in it. It provided about 12 hours of training in both interventions over an 8-week period, with an unspecified amount of home practice in the MBSR group. It provided up to 42 hours of home practice in the spirituality group. There was no information on teacher qualifications for MBSR. The study used the SF-36 vitality score to measure improvement in positive affect as a secondary outcome. The SF-36 vitality scores were 45 percent greater for the spirituality group (p=.024). This trial had a low risk of bias.

Jazaieri et al.⁸⁷ randomized patients with social anxiety disorder to MBSR or exercise (n=56). The trial provided about 25 hours of training by trained teachers, and their participants performed an average of 28.3 hours of homework over the 8-week training period. Although they did not specify primary or secondary outcomes, positive affect was identified as a primary focus of the study. The trial found a nonsignificant improvement of 10.2 percent in the satisfaction with life scale at 8 weeks in the MBSR group as compared with exercise. This trial was rated as high risk of bias.

Barrett et al.⁸⁵ randomized patients with a history of upper respiratory infections to MBSR or exercise (n=98). The trial provided about 20 hours of training by trained teachers, and approximately 42 hours of recommended homework over the 8-week training period. The positive and negative affect scale was a secondary outcome. The trial found no significant differences between the two arms in the positive portion of this scale at 9 weeks and 5 months. This trial had a medium risk of bias.

The difference-in-change graphs showed inconsistent results (Figure 23). A meta-analysis showed a nonsignificant and null effect (Figure 24).

The strength of evidence is insufficient regarding the effect mindfulness meditation programs have on positive affect among those with a mood disturbance or symptoms of anxiety when compared with a variety of specific active controls. We based this rating on overall medium risk of bias, inconsistent findings, indirect measures, and imprecise estimates (Table 33).

Table 33

Grade of trials addressing the efficacy of mindfulness meditation programs on positive affect compared with progressive muscle relaxation or spirituality among various patients.

Mindfulness Meditation Programs Versus Specific Active Control

Six trials evaluated the effect of mindfulness meditation programs compared with a specific active control on the outcome of the mental component of health-related QOL (Table 13). Five were MBSR trials and one was an MBCT trial. Three trials were low risk of bias, two medium, and one high. They used a variety of patient populations and specific active controls. Sample sizes ranged from 15–123.

Wong et al. randomized chronic pain patients (n=99) to an 8-week program in MBSR or multidisciplinary pain intervention.⁷⁴ The study used the validated Chinese SF-12 mental component subscale to measure QOL as a secondary outcome. There was no significant change in the scores between groups at 2 or 5 months. This trial had a low risk of bias, provided 27 hours of training and an unspecified amount of home practice over 8 weeks. Its teachers were trained and had 5 years of experience teaching meditation.⁷⁴

Gross et al. randomized people with insomnia (n=27) to 8 weeks of MBSR versus pharmacotherapy for sleep (eszopiclone).⁵⁵ The trial used the SF-12 mental summary score to measure QOL as a secondary outcome. There was no significant change in SF-12 scores between the two groups. This trial provided 26 hours of training and up to 36 hours of home practice over 8 weeks. Its teachers were trained and certified.

Moritz et al. randomized patients with mood disorders (n=110) to a spirituality program versus MBSR.⁶³ In this trial, MBSR was the active control. It provided about 12 hours of training in both interventions over an 8-week period, with unspecified amount of home practice in the MBSR group. It provided up to 42 hours of home practice in the spirituality group. There was no information on teacher qualifications for MBSR. The trial used the SF-36 mental component survey to measure QOL as a secondary outcome. They found a 23 percent change favoring spirituality at 8 weeks (p=.029). This trial had a low risk of bias. It is notable that this intervention included a meditative component, as well as breathing exercises that may resemble features of MBSR.

Plews-Ogan et al. randomized people with chronic musculoskeletal pain (n=15) to 8 weeks of MBSR training or weekly massage.⁶⁹ The trial used the SF-12 mental health score to measure QOL as a primary endpoint. The difference-in-change point estimates were 10.8 percent favoring massage at 8 weeks and 18.4 percent favoring MBSR at 12 weeks. The trial did not calculate significance for difference-in-change estimates. This trial provided 20 hours of training over 8 weeks, and unspecified amount of home practice. There was no information on teacher qualifications. It had a high risk of bias.

Kuyken at al. randomized depressed patients at risk for relapse (n=123) to 8 weeks of MBCT and antidepressant tapering or maintenance antidepressant therapy.⁵⁹ The trials used the World Health Organization quality of life instrument psychological subscale to measure QOL as a secondary outcome. At 3 months it found a 9.2 percent improvement in the MBCT group, which maintained at 15 months (p=.01). This trial provided 24 hours of training over 8 weeks by trained and certified instructors, and recommended up to 37.5 hours of home practice during that time. This trial had a low risk of bias.

Barrett et al.⁸⁵ randomized patients with a history of upper respiratory infections to MBSR or exercise (n=98). The trial provided about 20 hours of training by trained teachers, and approximately 42 hours of recommended homework over the 8-week training period. QOL was a secondary outcome. The trial found no significant differences between the two arms in the SF-12 mental component at 9 weeks and 5 months. This trial was rated as medium risk of bias.

The difference-in-change graphs showed inconsistent results (Figure 26). Meta-analysis showed a null and nonsignificant effect (Figure 30).

The strength of evidence is insufficient that mindfulness meditation program have an effect on the mental component of health-related quality of life among various clinical populations when compared with a variety of specific active controls. We based this rating on overall medium risk of bias, inconsistent findings, direct measures, and imprecise estimates (Table 34).

Table 34

Grade of trials addressing the efficacy of mindfulness meditation programs on the mental component of health-related quality of life compared with specific active controls among various populations.