Main Study Findings and Author’s Conclusions

APPENDIX 4Main Study Findings and Author’s Conclusions

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Table A7

Summary of Findings of Included Studies.

Table A8

Summary of Findings of Included Studies.

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Mindfulness Interventions for the Treatment of Post-Traumatic Stress Disorder, Generalized Anxiety Disorder, Depression, and Substance Use Disorders: A Review of the Clinical Effectiveness and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2015 Jun 19. APPENDIX 4, Main Study Findings and Author’s Conclusions.

Table A7Summary of Findings of Included Studies

Main Study Findings	Author’s Conclusions
Patients with Post-Traumatic stress disorder (PTSD)
Azad and Zadeh 2014,²⁴ Iran
In comparison with the control group, there was a statistically significant increase in the mean scores of the physical and psychiatric health, social relationship and social setting and condition of the MBSR group in the post-test and delayed post-test (P < 0.01)	Mindfulness training can improve the QoL of veterans with PTSD
Omidi et al. 2013,²⁵ Iran
Comparison of the results between the MBSR and TAU showed that anger and vitality scales have no significant differences, but on the other scales depression, dizziness, fatigue and tension showed significance difference between the two groups in favour of MBSR (P < 0.01)	MBSR is a useful method to regulate the mood state in veterans with PTSD who have difficulties in mood and emotions
Kearney et al. 2013,³¹ US
There was no significant difference between MBSR and TAU groups in PTSD and depression symptoms at the post treatment and 4-month time points. For mental HRQoL there was a medium-to-large effect size in favour of MBSR at post treatment (mean difference in the Mental Component Summary Score of SF-8 was 0.69, 95% CI: 0.07, 1.32), but at 4 months there was no significant difference between treatment groups. For physical HRQoL there was no significance difference between treatment groups at post treatment but at 4 months there was a medium-to-large effect size in favour of MBSR (mean difference in the PCS Physical Component Summary of SF-8 was 0.73, 95% CI: 0.09, 1.37)	Additional studies are needed to assess MBSR for veterans with PTSD
Patients with Depression
Clarke et al. 2015,¹⁹ UK, SR and MA.
The average risk of developing a new episode of depression by 12 months was reduced by 21% for MBCT (RR = 0.79, 95% CI, 0.69 to 0.91, I² = 0%)	There was evidence that MBCT is effective in reducing risk of relapse following recovery from depression. It was largely tested following medication, so its efficacy following psychological interventions is less clear
Jain et al. 2015,¹⁶ US, SR
Relative to wait list or treatment as usual controls, the between- group effect sizes (Hedges g) in the five studies using MBCT favour MBCT and were moderate to large (0.47 to 1.09). In the study that used psychoeducation control group arm, between- group effect size (Hedges g) favoured MBCT and was 0.75. Two studies for MD compared MBCT vs CBT and showed no significant differences in reduction of depressive symptoms between these two interventions	The role of meditation techniques in the clinical armamentarium for depression has not been firmly established. Existing RCTs are demonstrating reductions in depressive symptoms, and although the variability both within the clinical populations and the techniques studied suggests wide generalizability across depressive condition type and illness stage, the absence of well-matched control groups and the lack of large replication trials also limit the reliability and specificity of the results and conclusions that may be drawn
Churchill et al. 2013,¹⁸ UK, SR
A significant difference in depression levels favoured ACT compared with TAU, mean difference (−0.60, 95% CI −1.16, −0.04, P = 0.035)	While the findings from the review appear to suggest that third wave CBT approaches are more effective than TAU conditions in treating the acute symptoms of depression, the very low quality of the evidence base limits the ability to draw conclusions on their efficacy, either as individual approaches or as a collective approach
Strauss et al. 2014,²⁰ UK, SR and MA.
There were significant post-intervention between-group differences for people diagnosed with a depressive disorder with a large effect size in favour of MBI on primary symptom severity (Hedges g =−0.73, 95% CI,−1.36 to −0.09, z(3)= 2.24, P = 0.03	Significant benefits relative to control conditions for primary symptom severity for people experiencing a current episode of depression following MBIs (namely MBCT or PBCT) were found
Kuyken et al. 2015,²¹ UK, PREVENT study, RCT
The time to relapse or recurrence of depression did not differ between MBCT-TS and maintenance antidepressants over 24 months, nor did the number of serious adverse events. Also there was no significant difference between treatment groups for depression symptoms and QoL	No evidence was found to conclude that MBCT-TS is superior to maintenance antidepressant treatment for the prevention of depressive relapse in individuals at risk for depressive relapse or recurrence. Both treatments were associated with enduring positive outcomes in terms of relapse or recurrence, residual depressive symptoms, and QoL
Meadows et al. 2014,²² Australia, RCT
The average number of days with major depression was 65 for MBCT participants significantly less than those for controls (112 days) Fewer MBCT participants relapsed in both year 1 (33.7% vs 46.8%) and year 2 (27.0% vs. 39.3%) compared to controls Kaplan-Meier survival analysis for time to first depressive episode was non-significant, although trends favoring the MBCT group were suggested	This study supports the effectiveness of MBCT in something closer to implementation in routine practice than has been studied hitherto. Observed effects were less strong than in some previous efficacy studies but appreciable and significant differences in outcome were detected. MBCT is most clearly demonstrated as effective for people receiving specialist care and seems to work well combined with antidepressants
Chiesa et al. 2015,²³ Italy, RCT
Both HRSD and BDI scores, as well as QoL showed higher improvements, which were particularly evident over the long-term period, in the MBCT group than in the psychoeducation group	Results suggest the superiority of MBCT over psychoeducation for non-remitted MD subjects
Tovote et al. 2014,²⁶ Netherlands, RCT
Participants receiving MBCT and CBT reported significantly greater reductions in depressive symptoms compared with patients in the waiting list control condition. Both interventions MBCT and CBT also had significant positive effects on anxiety, well-being	MBCT and CBT are effective in improving a range of psychological symptoms in individuals with type 1 and type 2 diabetes
Bedard et al. 2014,²⁷ Canada, RCT
A greater reduction in BDI-II scores for the MBCT group than the control group. The improvement BDI-II scores was maintained at the 3-month follow-up. However there was no statistical significance for either PHQ-9 or SCL-90-R depression scale	Results are consistent with those of other researchers that use MBCT to reduce symptoms of depression
Patients with GAD
Strauss et al. 2014,²⁰ UK, SR and MA.
In the one study for patients with GAD, there were significant post-intervention between-group differences for people diagnosed with GAD with a large effect size in favour of MBI on primary symptom severity (Hedges g =−5.29, 95% CI, −6.87 to −3.72)	No conclusion was mentioned related to GAD
Bolognesi et al. 2014,¹⁵ UK, SR
MBSR: One study reported that an 8-week group intervention based on MBSR significantly reduced anxiety and depressive symptoms in individuals with GAD, another study reported a significant reduction in anxiety symptoms, but not in depressive symptoms, in GAD patients treated with MBSR compared to an education program group. Another study found that in patients with GAD, MBSR had sustained beneficial effects compared to a waiting list control condition. MBCT: two open non-controlled studies suggested the efficacy of MBCT significantly decreased anxiety, tension, worrying and depressive symptoms in patients with GAD. In another study the MBCT group demonstrated significantly greater decreases than the education program across all anxiety and depression scales in patients with GAD ABBT: A study in GAD suggested that ABBT was associated with considerable improvements in anxiety, worrying and depression at the conclusion of treatment, with benefits persisting at 3 months follow-up In two studies that compared to waiting list, it was found that ABBT more effective in decreasing anxiety and depressive symptoms in patients with GAD	mindfulness techniques have shown beneficial effects in treating GAD
Hayes-Skelton et al. 2013,²⁹ USA, RCT
There was no significant difference between ABBT and AR in CSR, SIGH-A, and QOLI scales	ABBT is a viable alternative for treating GAD
Hoge et al. 2013,³⁰ US, RCT
There was no significant difference between MBSR and SME groups in HAM-A scores at endpoint. MBSR, was associated with a significantly greater reduction in anxiety as measured by the CGI-S, the CGI-I, and the BAI. MBSR was also associated with greater reductions than SME in anxiety and distress ratings	Results suggest that MBSR may have a beneficial effect on anxiety symptoms in GAD, and may also improve stress reactivity
Patients with Substance Use Disorders
Chiesa and Serretti 2014,¹⁷ Italy, SR
MBRP outperforms programs based on the 12-step program, Vipassana retreat outperformed an educational Intervention and that both DBT and 3S-therapy were significantly more effective than no-treatment conditions for the reduction of SUM in heterogeneous samples of drug users. Smoking cessation studies consistently document that different MBIs including ACT and MBRP can be as or more effective than some established treatments for smoking cessation (i.e., NRT and CBT) and that MBSR could have at least a non-specific effect on smoking cessation. Positive findings were likewise observed in participants with opiate dependence and in marijuana misusers. Lack of randomization or of randomization details, small sample size, lack of objective measures of drug use and of information about treatment adherence raise concerns as to whether observed findings are actually due to the delivered interventions or are more properly attributable to methodological biases of included studies	Current evidence suggests that MBIs can reduce the consumption of several substances of misuse including alcohol, cocaine, methamphetamines, marijuana, cigarette smoking, and opiates to a significantly higher extent than several types of active and inactive control groups. Moreover, MBIs can improve several psychological outcomes associated with drug consumption
Bowen et al. 2014,²⁸ US, RCT
Compared with TAU, participants assigned to MBRP reported significantly lower risk of relapse to substance use and heavy drinking and, among those who used substances, significantly fewer days of substance use and heavy drinking at the 6-month follow-up. RP showed an advantage over MBRP in time to first drug use. At the 12-month follow-up, MBRP participants reported significantly fewer days of substance use and significantly decreased heavy drinking compared with RP and TAU	RP and MBRP are beneficial aftercare interventions compared with typical 12-step aftercare treatment. MBRP also resulted in significantly less drug use and a lower probability of any heavy drinking than RP at a 12-month follow-up. These results suggest that MBRP may support longer term sustainability of treatment gains for individuals with substance use disorders

: 3S-therapy = Spiritual self-schema therapy; ABBT = Acceptance-Based Behavioral Therapy; ACT = Acceptance and Commitment Therapy; AR = Applied Relaxation; BAI = Beck Anxiety Inventory; BDI = Beck Depression Inventory; BDI-II = Beck Depression Inventory II; CBT = cognitive behavior therapy; CGI-S = Clinical Global Impression of Severity; CGI-I = Clinical Global Impression of Improvement; CSR = clinician’s severity rating; DBT = Dialectical behavioral therapy; GAD = Generalized Anxiety Disorder; HAM-A = Hamilton Anxiety Rating Scale; HRQoL = Health-related quality of life; HRSD = Hamilton Rating Scale for Depression; MBCT = Mindfulness-Based Cognitive Therapy; MBCT-TS = MBCT with support to taper or discontinue antidepressant treatment; MBI = Mindfulness-based intervention; MBRP = Mindfulness-based relapse prevention; MBSR = Mindfulness-Based Stress Reduction; MD = major depression; MA = meta-analysis; NRT = Nicotine replacement therapy; PBCT = Person-Based Cognitive Therapy; PHQ-9 = The Patient Health Questionnaire-9; PTSD = post-traumatic stress disorder; QoL = Quality of Life; QOLI = Quality of Life Inventory; RCT = randomized controlled trial; RP = relapse prevention; SCL-90-R = Symptom Checklist-90-Revised; SIGH-A = Structured Interview Guide for the Hamilton Anxiety Rating Scale; SME = Stress Management Education; SR = systematic review; SUM = substance use and misuse; TAU = treatment as usual

Table A8Summary of Findings of Included Studies

Main Study Findings
Post-traumatic stress disorder
The Management of Post-Traumatic Stress working group, 2010³⁴ – US Department of Veterans Affairs
Complementary and alternative medicine such as mindfulness may be considered for adjunctive treatment of hyperarousal symptoms, although there is no evidence that these are more effective than standard stress inoculation techniques. The quality of evidence is poor, and the net benefit of the intervention is expected to range from zero or negative to substantial.
Depression
National Institute for Health & Clinical Excellence (NICE), 2010⁹
Mindfulness-Based Cognitive Therapy is recommended for people who are currently well but have experienced three or more previous episodes of depression. The strength of recommendations is not graded in NICE guidelines
Scottish Intercollegiate Guidelines Network (SIGN), 2010³³
Mindfulness based cognitive therapy in a group setting may be considered as a treatment option to reduce relapse in patients with depression who have had three or more episodes. A body of evidence including high quality systematic reviews of case control or cohort studies or high quality case control or cohort studies with a very low risk of confounding or bias, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from high quality meta-analysis, systematic reviews of RCTs or RCTs with low risk of bias
Parikh et al., 2009³² – Canadian Network for Mood and Anxiety Treatments (CANMAT)
Mindfulness-Based Cognitive Therapy is recommended as second-line therapy (cognitive behavioral therapy is first-line) for maintenance phase of major depressive disorders. Evidence based on at least 2 RCTs with adequate sample sizes, preferably placebo-controlled, and/or meta-analysis with narrow confidence intervals (level 2 of 4). Cognitive behavior therapy and interpersonal therapy are the only first-line treatment recommendations for acute major depressive disorder and remain highly recommended for maintenance.
The Management of MDD working group, 2008³⁵ - US Department of Veterans Affairs
Cognitive behavioral therapy, Cognitive Therapy, or Mindfulness-Based Cognitive Therapy (MBCT) should be used during the continuation phase of treatment with patients at high risk for relapse (i.e., two or more prior episodes, double depression, unstable remission status) to reduce the risk of subsequent relapse/recurrence. A strong recommendation that clinicians provide the intervention to eligible patients.
Substance use disorders
Mental Health and Drug and Alcohol Office, 2008¹⁰ – New South Wales Department of Health
Mindfulness-Based Stress Reduction can be used to treat problematic drug and alcohol use problems by suitably trained and experienced drug and alcohol professionals. The recommendation is supported by at least Level 3 research and expert clinical opinion (level 2 of 3)

: MDD = major depressive disorder