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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.

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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].

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APPENDIX 2Characteristics of Included Publications

Table A1Characteristics of Included Systematic Reviews and Meta-Analyses

First Author,
Publication
Year,
Country
Types and numbers
of primary studies
included
Population
Characteristics
InterventionComparator(s)Clinical Outcomes,
Length of Follow-Up
Notes
Clarke et al. 2015,19
UK
SR and MA, included RCT with minimum 1 year follow-up after randomization and with sample size ≥ 5 patients.

Literature search: from inception to December 2013.

29 trials were included in the narrative review and 22 trials included in the meta-analysis. 7 of these trials used MBCT
Adults with full or partial remission from depression. Number of patients ranged from 60 to 274 in MBCT trialsNon-pharmacological intervention aimed at reducing relapse of depression. All 7 MBCT studies offered eight weekly two-hour sessions to groups of between 9 and 15 people with some variation in the number of additional sessions offered from none to monthly sessions for the trial durationAny comparator.
TAU was used in 4 out of the 7 MBCT studies, maintenance ADM was used in 1 MBCT study, ADM/clinical management + placebo was used in 1 study, and Cognitive psychological education + TAU or TAU was used in one study
Relapse of depression measured using DSM-IV diagnosis of MDE in two studies, DSM-IV diagnosis of MDE (SCID) in two studies, 16+ on the HRSD-17 assessed twice then criteria for MD measured with SCID in one study, DSM-III-R criteria for MDE (SCID) in one study and Criteria for MDE ≥ 2 weeks (SCID) in one study.
Follow-up ranged from 52 to 86 weeks
Jain et al. 2015,16
US
SR included RCTs only.
Literature search was through January 2014.
18 trials were included in the systematic review. 8 of these trials used MBCT
Adult patients suffering from depressive disorder (i.e. MD, dysthymia, or both)
Number of patients ranged from 18 to 219 in MBCT trials
Meditation therapiesNot specified.
TAU was used in 4 studies out of the 8 trials, PED was used in 1 trial, ADM was used in 1 study, wait list was used in 1 study, and CBT was used in 2 studies
Reduction of depressive symptoms using
BDI-II in 3 studies, HRSD in 3 studies, BDI in one study, and general severity index of brief symptom inventory in one study. Length of follow-up was not mentioned
The review included two trials using MBCT that are common with other systematic reviews
Churchill et al. 2013,18
UK
SR included RCTs only.

Literature search was through March 2013.

4 trials were included in the review. 1 of these trials used ACT
Adult patients with acute depression.

Number of patients included in ACT trial was 54
ACT, compassionate mind training, functional analytic psychotherapy, dialectical behavior therapy, MBCT, extended behavioral activation and metacognitive therapy. The study that used ACT intervention offered 4 weekly sessions in a group format of 2 to 10 participantsTreatment as usual, waiting list, attention placebo, psychological placebo.
Supportive group comparison was used as comparator in the study that used ACT intervention
Number of participants who responded to treatment and number of participants who remitted. The trial with ACT intervention used BDI-II to measure continues change in depression scores
Strauss et al. 2014,20
UK
SR and MA of RCTs.

Literature search was through July 2013.

12 trials were included in this review, of those six trials used MBCT, 5 used MBSR, and one used PBCT intervention
Adult patients with anxiety or depressive disorder.

4 trials included patients with depression (three of these trials used MBCT, and one trial used PBCT, with number of patients ranged from 18 to 69), and one trial included 31 patients with GAD where MBSR was used
MBIsGroup CBT, group psychoeducation and inactive control conditions (TAU, wait list, aerobic exercise).
In the Depression studies group psychoeducation was used in 1 study, group CBT was used in 1 study and TAU was used in two studies
BDI-II, and HRSDThe review included two trials on depression patients that are common with other systematic reviews
Bolognesi et al. 2014,15
UK
SR

Literature search was through September 2012.

3 studies using MBCT, 3 studies using MBSR and three studies using ABBT were included in this review
Patients with GAD.

Number of patients ranged from 11 to 46 in MBCT trials, from 18 to 76 in MBSR trials, and 16 to 31 in ABBT trials
CBT, CBT Packages, new CBT approaches, third wave CBT, Internet computer based CBT, psychodynamic therapy, brief psychodynamic therapy, AR and mindfulnessAny or none

No control group was used in two of the MBCT studies, and ADE was used in 1 study.
Waiting list was used in 1 study, no control group was used in 1 study, and education program was used in 1 study in the MBSR studies. Waiting list was used in two of the ABBT studies, and no control group used in 1 study
BAI
HAM-A
HRSD
PSWQ
Chiesa and Serretti 2014,17
Italy
SR

Literature search was through December 2011.

24 studies were included of which 14 were RCTs and ten were non-RCTs
adult patients receiving treatment for SUM

12 studies focused on alcohol and/or heterogeneous substance use, four on cigarette smoking, three on opiate use, one on marijuana use, and one on metamphetamine use
MBI

eight studies focused on MBSR or related MBI, five on ACT, three on 3S-therapy, two on DBT, one study focused on a Vipassana retreat, one study focused on a goal management training in adjunct to mindfulness meditation, and one study focused on a brief motivational intervention in adjunct to mindfulness meditation
either inactive (e.g., waitlist) or active (i.e., condition intended to control for non-specific effects of MBIs

10 compared MBIs to a waitlist, eight compared MBIs with an active treatment, two compared MBIs with non-specific educational interventions designed to be structurally equivalent to the MBIs
difference between MBIs and active or inactive comparators on measures of objective and subjective SUM reduction

3S-therapy = Spiritual self-schema therapy; ABBT = Acceptance-based behavior therapy; ACT = Acceptance and Commitment Therapy; ADE = anxiety disorder education program; ADM = antidepressant medication; BAI = Beck Anxiety Inventory; BDI-II = Beck Depression Inventory II; DSM = Diagnostic Statistical Manual; CBT = cognitive behavior therapy; GAD = Generalized Anxiety Disorder; DBT = Dialectical behavioral therapy; HAM-A = Hamilton Anxiety Rating Scale; HRSD = Hamilton Rating Scale for Depression; MA = meta-analysis; MBCT = Mindfulness-Based Cognitive Therapy; MBI = Mindfulness-based intervention; MBSR = Mindfulness-Based Stress Reduction; MD = major depression; MDE = Major Depressive Episode; PBCT = Person-Based Cognitive Therapy; PED = psychoeducation group; PSWQ = Penn State Worry Questionnaire; RCT = randomized controlled trial; SCID = Structured Clinical Interview for DSM Disorders; SR = systematic review; SUM = substance use and misuse; TAU = treatment as usual

Table A2Characteristics of Included Clinical Studies

First Author,
Publication Year,
Country, Study
Name
Study DesignPatient
Characteristics
Intervention(s)Comparator(s)Clinical Outcomes
Patients with Post-Traumatic stress disorder (PTSD) Trials
Azad and Zadeh 2014,24
Iran
RCT and included a pre-test, post-test and delayed post-test with a control group.
Single-blind
Single center
N=32
Male warfare veterans of Iran-Iraq war diagnosed with PTSDMBSR, n=14No treatment, n=14WHOQOL-26
Omidi et al. 2013,25
Iran
RCT
Single center
N=62
Veterans with PTSDMBSR, n=31TAU, n=31BRUMS
Kearney et al. 2013,31
US
RCT
Single center
N = 47
veterans with PTSDMBSR, n=25TAU, n=22PTSD checklist civilian version, Life events checklist The patient Health Questionnnaire-9 The Short Form-8
Patients with depression
Kuyken et al. 2015,21
UK,
PREVENT study
RCT
Single-blind
multicentre
N=424
Adult patients with diagnosis of recurrent MD in full or partial remission, with three or more previous MDEs and on a therapeutic dose of maintenance antidepressant drugs8-week MBCT class that included support to taper or discontinue maintenance antidepressant medication (MBCT-TS), n=212maintenance antidepressant treatment, n=212Time to relapse or recurrence of depression. number of depression free days, QoL
Meadows et al. 2014,22
Australia
RCT
Single-blind
Multicenter
N=203
Non-depressed adults with a history of three or more episodes of depressionMBCT + DRAM, n=101DRAM, n=102proportion of relapse/recurrence days in MDEs time to relapse/recurrence
Chiesa et al. 2015,23
Italy
RCT
N=43
Patients diagnosed with MD, single or recurrent episode, age between 18 and 65 years, on treatment with antidepressants at adequate dosages for at least 8 weeks before study beginning and failure to achieve remission during the screening visitMBCT, n=23Psychoeducation, n=20HRSD
BDI-II
BAI
PGWBI
Tovote et al. 2014,26
Netherlands
RCT
Single-blind
Multicenter
N=94
Patients aged between 18 and 70 years with type 1 or 2 diabetes diagnosed at least 3 months prior to inclusion and having symptoms of depression as indicated by BDI-II score of ≥ 14MBCT, n=31CBT, n=32, waiting list, n=31BDI-II
HAMD-7
Bedard et al. 2014,27
Canada
RCT
Multicenter
N=105
adults with symptoms of depression after a traumatic brain injuryMBCT, n=57Waiting list, n=48BDI-II
PHQ-9
SCL-90-R
Patients with generalized anxiety disorder
Hayes-Skelton et al. 2013,29
US
RCT
N=81
Adult patients with principal diagnosis of GAD with at least moderate severity were includedABBT, n=40AR, n=41CSR
SIGH-A
QOLI
Hoge et al. 2013,30
US
RCT
Single-blind
Single center
N=93
Adult patients who met DSM-IV criteria for current primary GAD and designated GAD as the primary problem, and scored 20 or above on the HAM-AMBSR, n=48SME, n=41HAMA-A
CGI-S
CGI-I
BAI
Patients with substance use disorders
Bowen et al. 2014,28
US
RCT
Multicenter
N=286
Adult patients enrolled in a substance abuse aftercare programMBRP, n=103RP, n=88
or
TAU, n=95
relapse to drug use and heavy drinking frequency of substance use in the past 90 days

ABBT = Acceptance-Based Behavioral Therapy; ADIS-IV = Anxiety Disorders Interview Schedule; AR = Applied Relaxation; BAI = Beck Anxiety Inventory; BDI-II = Beck Depression Inventory II; BRUMS = Inventory of mood status; CBT = cognitive behavior therapy; CGI-S = Clinical Global Impression of Severity; CGI-I = Clinical Global Impression of Improvement; CSR = clinician’s severity rating; DRAM = Depression Relapse Active Monitoring; HAM-A = Hamilton Anxiety Rating Scale; HAMD-7 = 7 Item Hamilton Depression Rating Scale; HRSD = Hamilton Rating Scale for Depression; MBCT = Mindfulness-Based Cognitive Therapy; MBCT-TS = MBCT with support to taper or discontinue antidepressant treatment; MBRP = Mindfulness-based relapse prevention; MBSR = Mindfulness-Based Stress Reduction; MD = major depression; MDE = major depressive episodes; PGWBI = Psychological General Well Being Index; 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; TAU = treatment as usual; WHOQOL-26 = World Health Organization Quality of Life Questionnaire

Table A3Characteristics of Included Guidelines

ObjectivesMethodology
Intended users/
Target population
Intervention and
Practice
Considered
Major Outcomes
Considered
Evidence identification,
Synthesis and evaluation
Recommendations
development and
Evaluation, and guideline
validation
Post-traumatic stress disorder
The Management of Post-Traumatic Stress Working Group, 201034 – US Department of Veterans Affairs
The intended users included nurses and advanced practice nurses, health care providers, health plans, hospitals, managed care organizations, physicians and their assistants, psychologists/non-physician behavioral health clinicians, public health departments, social workers and substance use disorders treatment provides.
The target population includes adult patients with PTSD treated in by the Veterans Administration or Department of Defense
  • PTSD screening
  • Management of acute stress reaction
  • Management of PTSD
  • Treatment interventions for PTSD
    • Selection of therapy
    • Psychotherapy
    • Pharmacotherapy
    • Adjunctive services
    • Somatic treatment
    • Complementary & alternative medicine
      • mindfulness
      • yoga
      • acupuncture
      • massage
  • Improvement in QoL
  • Reduced morbidity/mortality
  • Improvement over long term
  • Patient satisfaction
  • Co-morbidity
  • Improvement of symptoms
A working group composed from different clinical fields and methodologists (data analysts) participated in the screening, selection, data extraction, and evidence evaluation from the selected literature.

Evidence synthesis was based on review of published meta-analyses and systematic review with evidence tables

Quality and strength of evidence were evaluated by expert consensus, and they were rated according to a pre-defined scheme
Recommendations were formulated by a consensus among the participating clinical experts. The clinical experts used the synthesized evidence, and the strength of recommendations was based on the quality and strength of evidence.

The guideline was validated by an external and internal reviews
Depression
National Institute for Health & Clinical Excellence (NICE), 20109
The intended users were not explicitly specified.

The target population is adults with depression
  • psychological and psychosocial
  • cognitive behavioral therapies
  • mindfulness-based cognitive therapy
  • behavioral activation
  • guided self-help
  • physical activity programs
  • interpersonal therapy
  • others
  • mortality
  • morbidity
  • treatment complications
  • rates of relapse
  • late morbidity and readmission
  • return to work
  • physical and social functioning
  • QoL
  • general health status
  • costs
A systematic review of the literature was used to identify relevant evidence. Evidence was synthetized by meta-analyses and evidence profile tables.

The quality of the included studies was evaluated before considering them as evidence
Recommendations were formulated by consensus among the working group after reviewing the evidence and its strength profile.

Validation of the guideline was done by the review of registered stakeholders who included patients, patients groups, and professional providing care for patients
Scottish Intercollegiate Guidelines Network (SIGN), 201033
The intended users included developers of mental health services, healthcare professionals in primary and secondary care.
The target population included adult patients with depression and their carers
  • Self-help
  • Structured exercise
  • Psychological therapies
    • Behavioral activation
    • CBT
    • Hypnotherapy
    • Mindfulness based cognitive therapy
    • Others
The primary outcome was reduction in depressive symptom. Secondary outcomes included illness duration, relapse, QoL and patient satisfactionA systematic literature review was carried out. A working group of different clinical fields and methodologists participated in the development of the guideline. The selection and synthesis of each included study was done by two reviewers.

The quality of the included studies was evaluated before considering them as evidence
Recommendations were formulated by expert consensus.

Validation of the guideline was done through national open meeting and specialist review
Parikh et al., 200932 – Canadian Network for Mood and Anxiety Treatments (CANMAT)
The intended users were not explicitly specified in the guideline.

The target population was adults with MD
  • Psychotherapy
  • CBT
  • Interpersonal therapy
  • MBCT
  • Psychodynamic psychotherapy
  • Cognitive Behavioural Analysis System of Psychotherapy
  • Behavioural Activation
  • Others
Outcomes were not explicitly reported in the guidelineA working group participated in the screening, selection, data extraction, and evidence evaluation from the selected literature.

Evidence synthesis was based on review of published RCTs and meta-analyses and review with evidence tables.

Quality of the included studies was not evaluated
The guideline provided high level evaluation of the strength of recommendations based on the type and number of studies supporting each recommendation.

The guideline was validated by an external and internal reviews
The Management of MD Working Group, 200835 - US Department of Veterans Affairs
The intended users included all healthcare professionals who have direct contact with patients with MD, and who make decisions about their care.

The target population was adult patients with MD
  • Pharmacotherapy
  • Psychotherapy
    • CBT
    • Interpersonal psychotherapy
    • Problem solving therapy
    • Behavioral activation
    • Acceptance and mindfulness
    • Others
  • depressive symptoms
  • functional status
  • suicide risk
  • adverse effects and tolerability
  • adherence to treatment
A working group composed from different clinical fields and methodologists (data analysts) participated in the screening, selection, data extraction, and evidence evaluation from the selected literature.

Evidence synthesis was based on review of published meta-analyses and systematic review with evidence tables.

Quality and strength of evidence were evaluated by expert consensus, and they were rated according a predefined scheme
Recommendations were formulated by a consensus among the participating clinical experts. The clinical experts used the synthesized evidence, and the strength of recommendations was based on the quality and strength of evidence.

The guideline was validated by an external and internal reviews
Substance use disorders
Mental Health and Drug and Alcohol Office, 200810 – New South Wales Department of Health
The intended users included all allied health disciplines within drug and alcohol specialist services that provide direct clinical psychosocial interventions
  • Cognitive Behavioural Therapies
  • Psychodynamic and interpersonal approaches
  • Emotion Regulation
  • Mindfulness-Based Stress Reduction
  • Dialectical Behaviour Therapy
  • Acceptance and Commitment Therapy
  • Family approaches
  • Others
The guideline did not specify outcomes, but several co-morbidities were evaluated. These included depression, anxiety, psychosis, personal disorders, trauma, anger/aggression, pain and blood-borne virusesThe process of evidence collection and synthesis was not reported in the guideline.

The authors of the guideline provided an evaluation for the strength of evidence-based on the type and number of studies, but the quality of the included studies was not evaluated or reported
The method used to formulate the recommendations was not reported.

The method of validation was not reported

CBT = cognitive behavior therapy; MD = major depression; PTSD = post-traumatic stress disorder; QoL = Quality of Life

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