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Comparative Effectiveness ReviewNumber 124Meditation Programsfor PsychologicalStress andWell-Being
Comparative Effectiveness ReviewNumber 124Meditation Programs for Psychological Stressand Well-BeingPrepared for:Agency for Healthcare Research and QualityU.S. Department of Health and Human Services540 Gaither RoadRockville, MD 20850www.ahrq.govContract No. 290-2007-10061-IPrepared by:Johns Hopkins University Evidence-based Practice CenterBaltimore, MDInvestigators:Madhav Goyal, M.D., M.P.H.Sonal Singh, M.D., M.P.H.Erica M.S. Sibinga, M.D., M.H.S.Neda F. Gould, Ph.D.Anastasia Rowland-Seymour, M.D.Ritu Sharma, B.Sc.Zackary Berger, M.D., Ph.D.Dana Sleicher, M.S., M.P.H.David D. Maron, M.H.S.Hasan M. Shihab, M.B.Ch.B., M.P.H.Padmini D. Ranasinghe, M.D., M.P.H.Shauna Linn, B.A.Shonali Saha, M.D.Eric B. Bass, M.D., M.P.H.Jennifer A. Haythornthwaite, Ph.D.AHRQ Publication No. 13(14)-EHC116-EFJanuary 2014
AddendumIn June 2013, we ran an updated search for the review from our last update in November2012. We used the same search criteria across the electronic databases, and after removal ofduplicate citations we identified 952 new citations. These citations underwent title-abstractreview, and 27 trials were pulled for full article review. Of these, six new trials met criteriafor inclusion in our review. Further details can be found online at: Goyal M, Singh S. SibingaEMS, et al. Meditation programs for psychological stress and well-being: a systematic reviewand meta-analysis. JAMA Intern Med. Epub Jan 6 2014. doi:10.1001/jamainternmed.2013.13018.Of the six new trials, one was a transcendental meditation trial among patients with HIV,involving nonspecific active controls. Of the remaining five mindfulness trials, two used anonspecific active control among patients with anxiety or sleep disturbance, and three used aspecific active control among patients with anxiety, depression or stress. Three trials contributedto the outcome of anxiety, four trials to the outcome of depression, three trials to the outcome ofstress/distress, one trial to the outcome of positive affect, and two trials to the outcome of sleep.The addition of these trials did not change the overall conclusions or the strength of evidencefor any of the outcomes. While the meta-analytic effect sizes for the outcomes where the newtrials contributed data changed slightly, the statistical significance did not change and theconfidence intervals changed only slightly. Thus only the effect sizes are reported here. For theoutcome of anxiety, the effect size changed from 0.40 to 0.38 for mindfulness programscompared with a nonspecific active control, and from 0.06 to 0.07 for mindfulness programscompared with specific active controls. For the outcome of depression, the effect size changedfrom 0.32 to 0.30 for mindfulness programs compared with nonspecific active controls, from0.16 to 0.11 for mindfulness programs compared with specific active controls and from 0.24 to0.27 for Mantra programs compared with nonspecific active controls. For the outcome ofnegative affect, the effect size changed from 0.34 to 0.33 for mindfulness programs comparedwith a nonspecific active control. For the outcome of positive affect, the effect size changed from0.31 to 0.28 for mindfulness programs compared with a nonspecific active control. For theoutcome of sleep, the effect size changed from 0.12 to 0.14 for mindfulness programs comparedwith a nonspecific active control.ii
This report is based on research conducted by the Johns Hopkins University Evidence-basedPractice Center (EPC) under contract to the Agency for Healthcare Research and Quality(AHRQ), Rockville, MD (Contract No. 290-2007-10061-I). The findings and conclusions in thisdocument are those of the authors, who are responsible for its contents; the findings andconclusions do not necessarily represent the views of AHRQ. Therefore, no statement in thisreport should be construed as an official position of AHRQ or of the U.S. Department of Healthand Human Services.The information in this report is intended to help health care decisionmakers—patients andclinicians, health system leaders, and policymakers, among others—make well-informeddecisions and thereby improve the quality of health care services. This report is not intended tobe a substitute for the application of clinical judgment. Anyone who makes decisions concerningthe provision of clinical care should consider this report in the same way as any medicalreference and in conjunction with all other pertinent information, i.e., in the context of availableresources and circumstances presented by individual patients.This report may be used, in whole or in part, as the basis for development of clinical practiceguidelines and other quality enhancement tools, or as a basis for reimbursement and coveragepolicies. AHRQ or U.S. Department of Health and Human Services endorsement of suchderivative products may not be stated or implied.This report may periodically be assessed for the urgency to update. If an assessment is done, theresulting surveillance report describing the methodology and findings will be found on theEffective Health Care Program Web site at: www.effectivehealthcare.ahrq.gov. Search on thetitle of the report.This document is in the public domain and may be used and reprinted without specialpermission. Citation of the source is appreciated.Persons using assistive technology may not be able to fully access information in this report. Forassistance contact [email protected] of the investigators have any affiliations or financial involvement that conflicts with thematerial presented in this report.Suggested citation: Goyal M, Singh S, Sibinga EMS, Gould NF, Rowland-Seymour A, SharmaR, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB,Haythornthwaite JA. Meditation Programs for Psychological Stress and Well-Being.Comparative Effectiveness Review No. 124. (Prepared by Johns Hopkins University Evidencebased Practice Center under Contract No. 290-2007-10061–I.) AHRQ Publication No. 13(14)EHC116-EF. Rockville, MD: Agency for Healthcare Research and Quality; January l.cfm.iii
PrefaceThe Agency for Healthcare Research and Quality (AHRQ), through its Evidence-basedPractice Centers (EPCs), sponsors the development of systematic reviews to assist public- andprivate-sector organizations in their efforts to improve the quality of health care in the UnitedStates. These reviews provide comprehensive, science-based information on common, costlymedical conditions, and new health care technologies and strategies.Systematic reviews are the building blocks underlying evidence-based practice; they focusattention on the strength and limits of evidence from research studies about the effectiveness andsafety of a clinical intervention. In the context of developing recommendations for practice,systematic reviews can help clarify whether assertions about the value of the intervention arebased on strong evidence from clinical studies. For more information about AHRQ EPCsystematic reviews, see .cfm.AHRQ expects that these systematic reviews will be helpful to health plans, providers,purchasers, government programs, and the health care system as a whole. Transparency andstakeholder input are essential to the Effective Health Care Program. Please visit the Web site(www.effectivehealthcare.ahrq.gov) to see draft research questions and reports or to join anemail list to learn about new program products and opportunities for input.We welcome comments on this systematic review. They may be sent by mail to the TaskOrder Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road,Rockville, MD 20850, or by email to [email protected] G. Kronick, Ph.D.DirectorAgency for Healthcare Research and QualityJean Slutsky, P.A., M.S.P.H.Director, Center for Outcomes and EvidenceAgency for Healthcare Research and QualityStephanie Chang, M.D., M.P.H.Director, EPC ProgramCenter for Outcomes and EvidenceAgency for Healthcare Research and QualityShilpa H. Amin, M.D., M.Bsc., FAAFPTask Order OfficerCenter for Outcomes and EvidenceAgency for Healthcare Research and Qualityiv
AcknowledgmentsThe authors gratefully acknowledge the continuing support of our AHRQ Task OrderOfficer, Shilpa H. Amin. We extend our appreciation to our Key Informants and members of ourTechnical Expert Panel (listed below), all of whom provided thoughtful advice and input duringour research process.The EPC thanks Swaroop Vedula for conducting meta-analyses and assisting with theirinterpretation. The EPC also thanks Manisha Reuben, Deepa Pawar, Oluwaseun Shogbesan, andYohalakshmi Chelladurai for their contributions to this project and Eric Vohr for his editorialcontribution.Key InformantsIn designing the study questions, the EPC consulted several Key Informants who representthe end-users of research. The EPC sought the Key Informant input on the priority areas forresearch and synthesis. Key Informants are not involved in the analysis of the evidence or thewriting of the report. Therefore, in the end, study questions, design, methodological approaches,and/or conclusions do not necessarily represent the views of individual Key Informants.Key Informants must disclose any financial conflicts of interest greater than 10,000 and anyother relevant business or professional conflicts of interest. Because of their role as end-users,individuals with potential conflicts may be retained. The TOO and the EPC work to balance,manage, or mitigate any conflicts of interest.The list of Key Informants who participated in developing this report follows:Richard J. Davidson, Ph.D.University of WisconsinMadison, WIJohn R. Glowa, Ph.D.National Center for Complementary and Alternative MedicineBethesda, MDBarbara L. Niles, Ph.D.National Center for PTSDBoston University School of MedicineBoston, MADr. David Orme-Johnson, Ph.D.ConsultantSeagrove Beach, FLRobert Schneider, M.D., FACC, FABMRProfessor and DirectorInstitute for Natural Medicine and PreventionDean, Maharishi College of Perfect HealthMaharishi University of ManagementMaharishi Vedic City, IAv
Technical Expert PanelIn designing the study questions and methodology at the outset of this report, the EPCconsulted several technical and content experts. Broad expertise and perspectives were sought.Divergent and conflicted opinions are common and perceived as healthy scientific discourse thatresults in a thoughtful, relevant systematic review. Therefore, in the end, study questions, design,methodologic approaches, and/or conclusions do not necessarily represent the views ofindividual technical and content experts.Technical Experts must disclose any financial conflicts of interest greater than 10,000 andany other relevant business or professional conflicts of interest. Because of their unique clinicalor content expertise, individuals with potential conflicts may be retained. The TOO and the EPCwork to balance, manage, or mitigate any potential conflicts of interest identified.The list of Technical Experts who participated in developing this report follows:Kevin W. Chen, Ph.D., M.P.H.University of Maryland School of MedicineBaltimore, MDMargaret Chesney, Ph.D.UCSF School of MedicineSan Francisco, CASusan Gould-FogeriteUniversity of Medicine and Dentistry of New JerseyNewark, NJEdward Mills. Ph.D.University of OttawaOttawa, Ontario, CanadaKaren J. Sherman, Ph.D., M.P.H.Group Health Research InstituteSeattle, WABonnie TarantinoUniversity of Maryland School of MedicineBaltimore, MDPeer ReviewersPrior to publication of the final evidence report, EPCs sought input from independent PeerReviewers without financial conflicts of interest. However, the conclusions and synthesis of thescientific literature presented in this report does not necessarily represent the views of individualreviewers.Peer Reviewers must disclose any financial conflicts of interest greater than 10,000 and anyother relevant business or professional conflicts of interest. Because of their unique clinical orcontent expertise, individuals with potential nonfinancial conflicts may be retained. The TOOvi
and the EPC work to balance, manage, or mitigate any potential nonfinancial conflicts of interestidentified.The list of Peer Reviewers follows:Vernon Barnes, Ph.D.Georgia Prevention CenterInstitute of Public and Preventive HealthGeorgia Regents UniversityAugusta, GAVinjar Fonnebo, M.D., Ph.D.National Research Centre in Complementaryand Alternative Medicine (NAFKAM)University of TromsoTromso, NorwayDavid S. Black, Ph.D., M.P.H.Assistant Professor of Preventive MedicineInstitute for Prevention ResearchKeck School of MedicineUniversity of Southern CaliforniaLos Angeles, CARobert Kane, M.D.University of Minnesota School of PublicHealthMinneapolis, MNKathleen Kemper, M.D.Ohio State College of MedicineCenter for Integrative Health and WellnessColumbus, OHMary Butler, Ph.D., M.B.A.Associate Director, Minnesota EPCUniversity of Minnesota School of PublicHealthMinneapolis, MNMary Jo Kreitzer, Ph.D., R.N.Center for Spirituality & HealingUniversity of MinnesotaMinneapolis, MNAmparo Castillo, M.D., M.S.Training Coordinator and ResearcherMidwest Latino Health Research Trainingand Policy Center at theJane Addams College of Social Work andInstitute for Health Research and PolicyUniversity of Illinois at ChicagoChicago, ILvii
Meditation Programs for Psychological Stress andWell-BeingStructured AbstractObjectives. Meditation, a mind-body method, employs a variety of techniques designed tofacilitate the mind’s capacity to affect bodily function and symptoms. An increasing number ofpatients are using meditation programs despite uncertainty about the evidence supporting thehealth benefits of meditation. We aimed to determine the efficacy and safety of meditationprograms on stress-related outcomes (e.g., anxiety, depression, stress, distress, well-being,positive mood, quality of life, attention, health-related behaviors affected by stress, pain, andweight) compared with an active control in diverse adult clinical populationsData sources. We searched MEDLINE , PsycINFO , Embase , PsycArticles, SCOPUS,CINAHL, AMED, and the Cochrane Library in November 2012. We also performed manualsearches.Review methods. We included randomized controlled trials with an active control that reportedon the stress outcomes of interest. Two reviewers independently screened titles to find trials thatreported on outcomes, and then extracted data on trial characteristics and effect modifiers(amount of training or teacher qualifications). We graded the strength of evidence (SOE) usingfour domains (risk of bias, precision, directness, and consistency). To assess the direction andmagnitude of reported effects of the interventions, we calculated the relative difference betweengroups in how each outcome measure changed from baseline. We conducted meta-analysis usingstandardized mean differences to obtain aggregate estimates of effects with 95-percentconfidence intervals (CIs). We analyzed efficacy trials separately from comparative effectivenesstrials.Results. After a review of 17,801 citations, we included 41 trials with 2,993 participants. Mosttrials were short term, but they ranged from 4 weeks to 9 years in duration. Trials conductedagainst nonspecific active controls provided efficacy data. Mindfulness meditation programs hadmoderate SOE for improvement in anxiety (effect size [ES], 0.40; CI, 0.08 to 0.71 at 8 weeks;ES, 0.22; CI, 0.02 to 0.43 at 3–6 months), depression (ES, 0.32; CI, 0.01 to 0.66 at 8 weeks;ES, 0.23; CI, 0.05 to 0.42 at 3–6 months); and pain (ES, 0.33; CI, 0.03 to 0.62); and low SOE forimprovement in stress/distress and mental health–related quality of life. We found either lowSOE of no effect or insufficient SOE of an effect of meditation programs on positive mood,attention, substance use, eating, sleep, and weight. In our comparative effectiveness analyses, wedid not find any evidence to suggest that these meditation programs were superior to any specifictherapies they were compared with. Only 10 trials had a low risk of bias. Limitations includedclinical heterogeneity, variability in the types of controls, and heterogeneity of the interventions(e.g., dosing, frequency, duration, technique).Conclusions. Meditation programs, in particular mindfulness programs, reduce multiple negativedimensions of psychological stress. Stronger study designs are needed to determine the effects ofmeditation programs in improving the positive dimensions of mental health as well as stressrelated behavioral outcomes.viii
ContentsExecutive Summary .ES-1Introduction .1Definition of Meditation .1Current Practice and Prevalence of Use.1Forms of Meditation .1Psychological Stress and Well-Being .3Evidence to Date .4Clinical and Policy Relevance .4Objectives .5Scope and Key Questions .5Analytic Framework .5Methods .7Topic Development .7Search Strategy .7Study Selection .8Data Abstraction and Data Management .10Data Synthesis .12Assessment of Methodological Quality of Individual Studies .15Assessment of Potential Publication Bias .16Strength of the Body of Evidence .16Applicability .19Peer Review and Public Commentary .19Results .20Results of the Search .20Description of Types of Trials Retrieved .21Key Question Results .34Key Question 1. What are the efficacy and harms of meditation programs on negative affect(e.g., anxiety, stress) and positive affect (e.g., well-being) among those with a clinicalcondition (medical or psychiatric)? .47Key Points and Evidence Grades .47Trial Characteristics .49Population Characteristics .49Intervention Characteristics .50Outcomes .51Applicability .102Key Question 2. What are the efficacy and harms of meditation programs on attention amongthose with a clinical condition (medical or psychiatric)? .102Key Points and Evidence Grades .102Trial Characteristics .102Population Characteristics .103Intervention Characteristics .103Outcomes .103Applicability .104ix
Key Question 3. What are the efficacy and harms of meditation programs on health-relatedbehaviors affected by stress, specifically substance use, sleep, and eating, among those with aclinical condition (medical or psychiatric)? .104Key Points and Evidence Grades .104Trial Characteristics .105Population Characteristics .105Intervention Characteristics .105Outcomes .106Applicability .114Key Question 4. What are the efficacy and harms of meditation programs on pain and weightamong those with a clinical condition (medical or psychiatric)? .116Key Points and Evidence Grades .116Trial Characteristics .116Population Characteristics .116Intervention Characteristics .117Outcomes .118Assessment of Potential Publication Bias .126Applicability .126Discussion.129Key Question 1. What are the efficacy and harms of meditation programs on negative affect(e.g., anxiety, stress) and positive affect (e.g., well-being) among those with a clinicalcondition (medical or psychiatric)? .130Key Question 2. What are the efficacy and harms of meditation programs on attention amongthose with a clinical condition (medical or psychiatric)? .132Key Question 3. What are the efficacy and harms of meditation programs on health-relatedbehaviors affected by stress, specifically substance use, sleep, and eating, among those with aclinical condition (medical or psychiatric)? .132Key Question 4. What are the efficacy and harms of meditation programs on pain and weightamong those with a clinical condition (medical or psychiatric)? .133Harm Outcomes for All Key Questions .134Limitations of the Primary Studies .134Limitations of the Review.134Future Directions .136Conclusions .138References .140TablesTable A. Study inclusion and exclusion criteria .ES-6Table B. List of major and minor criteria in assessing risk of bias .ES-8Table 1. Study inclusion and exclusion criteria .9Table 2. Organization of various scales (instruments or measurement tools) for each KeyQuestion .11Table 3. List of major and minor criteria in assessing risk of bias .16Table 4. Characteristics of included trials.22Table 5. Training dose for included trials over duration of training period (numbers arecalculated from information provided in trials) .30Table 6. Teacher qualifications for included trials .31x
Table 7. Risk of bias for included trials .32Table 8. Synthesis summary for anxiety .38Table 9. Synthesis summary for depression .39Table 10. Synthesis summary for stress/distress.40Table 11. Synthesis summary for negative affect .41Table 12. Synthesis summary for positive affect (well being and positive mood) .42Table 13. Synthesis summary for quality of life/mental component of health-related qualityof life .43Table 14. Synthesis summary for substance use, eating, sleep .44Table 15. Synthesis summary for pain .45Table 16. Synthesis summary for weight .46Table 17. Grade of trials addressing the efficacy of mindfulness meditation programon anxiety compared with nonspecific active controls among various populations .53Table 18. Grade of trials addressing the efficacy of mantra meditation programs on anxietycompared with nonspecific active controls among various populations .57Table 19. Grade of trials addressing the efficacy of mindfulness meditation programson symptoms of depression compared with nonspecific active controls among clinicalpopulations. .60Table 20. Grade of trials addressing the efficacy of mantra meditation program on symptomsof depression compared with nonspecific active controls among cardiac and HIV populations .64Table 21. Grade of trials assessing the efficacy of mindfulness programs on stress and distresscompared with nonspecific active controls among various populations .67Table 22. Grade of tria
EMS, et al. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. Epub Jan 6 2014. doi:10.1001/ jamainternmed.2013.13018. Of the six new trls,ia one wsa a transcendental meditation trial among patients with HV,I involving nonspecific active controls.
