Copyright 2015 American Medical Association. All rights reserved.Mindfulness-Based Stress Reduction for Posttraumatic StressDisorder Among VeteransA Randomized Clinical TrialMelissa A. Polusny, PhD; Christopher R. Erbes, PhD; Paul Thuras, PhD; Amy Moran, MA; Greg J. Lamberty, PhD;Rose C. Collins, PhD; John L. Rodman, PhD; Kelvin O. Lim, MDIMPORTANCE Mindfulness-based interventions may be acceptable to veterans who have pooradherence to existing evidence-based treatments for posttraumatic stress disorder (PTSD).OBJECTIVETo compare mindfulness-based stress reduction with present-centered grouptherapy for treatment of PTSD.DESIGN, SETTING, AND PARTICIPANTSRandomized clinical trial of 116 veterans with PTSDrecruited at the Minneapolis Veterans Affairs Medical Center fromMarch 2012 to December2013. Outcomes were assessed before, during, and after treatment and at 2-month follow-up.Data collection was completed on April 22, 2014.INTERVENTIONSParticipants were randomly assigned to receive mindfulness-based stressreduction therapy (n = 58), consisting of 9 sessions (8 weekly 2.5-hour group sessions and adaylong retreat) focused on teaching patients to attend to the present moment in anonjudgmental, accepting manner; or present-centered group therapy (n = 58), anactive-control condition consisting of 9 weekly 1.5-hour group sessions focused on currentlife problems.MAINOUTCOMES AND MEASURESThe primary outcome, change in PTSDsymptomseverityover time, was assessed using the PTSDChecklist (range, 17-85; higher scores indicate greaterseverity; reduction of 10or more considered a minimal clinically important difference) atbaseline and weeks 3, 6, 9, and 17. Secondary outcomes included PTSDdiagnosis andsymptomseverity assessed by independent evaluators using the Clinician-AdministeredPTSDScale along with improvements in depressive symptoms, quality of life, andmindfulness.RESULTSParticipants in the mindfulness-based stress reduction group demonstrated greaterimprovement in self-reported PTSDsymptomseverity during treatment (change in mean PTSDChecklist scores from63.6to 55.7 vs 58.8to 55.8with present-centered group therapy;between-group difference, 4.95; 95%CI, 1.92-7.99; P=.002) and at 2-month follow-up (changein mean scores from63.6to 54.4 vs 58.8to 56.0, respectively; difference, 6.44; 95%CI,3.34-9.53, P < .001). Although participants in the mindfulness-based stress reduction groupwere more likely to showclinically significant improvement in self-reported PTSDsymptomseverity (48.9%vs 28.1%with present-centered group therapy; difference, 20.9%; 95%CI,2.2%-39.5%; P = .03) at 2-month follow-up, they were no more likely to have loss of PTSDdiagnosis (53.3%vs 47.3%, respectively; difference, 6.0%; 95%CI, 14.1%to 26.2%; P = .55).CONCLUSIONS AND RELEVANCEAmong veterans with PTSD, mindfulness-based stressreduction therapy, compared with present-centered group therapy, resulted in a greaterdecrease in PTSDsymptomseverity. However, the magnitude of the average improvementsuggests a modest effect.TRIAL REGISTRATIONclinicaltrials.gov Identifier: NCT01548742JAMA. 2015;314(5):456-465. doi:10.1001/jama.2015.8361Editorial page 453Author Video InterviewandJAMAReport Video atjama.comSupplemental content atjama.comAuthor Affiliations: MinneapolisVeterans Affairs Health Care System,Minneapolis, Minnesota(Polusny, Erbes, Thuras, Moran,Lamberty, Collins, Rodman, Lim);Center for Chronic Disease OutcomesResearch, Minneapolis, Minnesota(Polusny, Erbes); Department ofPsychiatry, University of Minnesota,Minneapolis (Polusny, Erbes, Thuras,Lamberty, Lim).Corresponding Author: Melissa A.Polusny, PhD, Minneapolis VAMedical Center (B68-2), OneVeterans Dr, Minneapolis, MN55417(melissa.polusny@va.gov).ResearchOriginal Investigation456 (Reprinted) jama.comCopyright 2015 American Medical Association. All rights reserved.Downloaded From: http://jama.jamanetwork.com/ by a University of Ottawa Useron 08/04/2015Copyright 2015 American Medical Association. All rights reserved.Posttraumatic stress disorder (PTSD) affects 23% ofveterans returning from deployments in Afghanistan(OperationEnduringFreedom) andIraq(OperationIraqiFreedom).1Left untreated, it is associated with high rates ofcomorbidity, disability, and poor quality of life.2The US De-partment of Veterans Af-fairs (VA) has investedheavily in the dissemina-tion of prolonged expo-sure therapy and cogni-tive processing therapy.3Robustevidencesup-ports the efficacy of these2 first-line treatments.4Yet 30% to 50% of veter-ans participating in pro-longedexposure or cogni-tiveprocessingtherapyfailto show clinically signifi-cant improvements,5,6anddropout is high, ranging from 30% to 38%5-7in randomizedtrials and32%to44%inclinic-basedstudies.8,9Arecent chartreview found that 60% of eligible Operation EnduringFreedom/OperationIraqi Freedomveterans failedto beginordropped out of these treatments.10Avoidance and difficul-ties tolerating trauma-focused material likely contribute todropout.7,11Thus, research aimed at testing novel treatmentsfor PTSD in this population is important.Evidence suggests that mindfulness-based stress reduc-tion, an intervention that teaches individuals to attend to thepresent moment in a nonjudgmental, accepting manner,12can result in reduced symptoms of depression and anxiety.13By encouraging acceptance of thoughts, feelings, and experi-ences without avoidance, mindfulness-based interventionstarget experiential avoidance, a key factor in the develop-ment and maintenance of PTSD.14This randomized clinicaltrial compared mindfulness-based stress reduction with anactive, credible intervention, present-centered grouptherapy. We hypothesized that veterans randomly assignedto mindfulness-based stress reduction would show greaterreductions in self-reported and interview-rated PTSD sever-ity and loss of diagnosis after treatment and at 2-monthfollow-up compared with those randomized to present-centered group therapy.MethodsParticipantsParticipants were veterans who met the following inclusioncriteria: (1) current full PTSD according to the Diagnostic andStatistical Manual of Mental Disorders (Fourth Edition)(DSM-IV)15or subthreshold PTSD, defined as endorsement ofDSM-IV criterion A1 and at least 1 symptom each from crite-ria B, C, and D with significant impairment; (2) agreement tonot receive other psychotherapy for PTSD during study; and(3) if being treated with psychoactive medications, a stableregimen for at least 2 months prior to study entry. Exclusioncriteria were (1) current substance dependence (except nico-tine or caffeine); (2) current psychotic disorder (eg, schizo-phrenia, bipolar disorder); (3) prominent current suicidal orhomicidal ideation; and (4) cognitive impairment or medicalillness that could interfere with treatment.ProceduresPatients were recruited through advertisements and clinicalreferrals at a large VA medical center. All patients providedwritten informed consent for participation in this study,which was approved by the Minneapolis VA Medical Centerinstitutional review board. Participants completed a 5-houreligibility and baseline assessment that included a struc-tured clinical interview and self-report measures. Masters-level assessors supervised by study authors (C.R.E. andG.J.L.) served as independent evaluators blinded to treat-ment condition. Posttraumatic stress disorder and Axis I psy-chiatric disorders were assessed using structured clinicalinterviews.16,17Outcomes were assessed before treatment, at3-week intervals during treatment (weeks 3 and 6), aftertreatment (week 9), and at 2-month follow-up (week 17).Data collection was completed April 22, 2014.Randomization was conducted using SAS PROC PLAN inblocks of 4 to ensure evenrandomizationacross the lengthofthestudy. Arestrictedelectronic randomizationchart was pro-videdtothestudycoordinator bythestatistician. Veteranswererandomized approximately every 2 months over a 19-monthperiod, for a total of 9cohorts composedof 1 groupeachof the2 conditions.The trial protocol is available in the Supplement.Treatment ConditionsTreatment was deliveredinagroupformat accordingtomanu-alized protocols by 2 instructors/clinicians. For mindfulness-basedstress reduction, leadinstructors completeda 9-dayin-tensive practicumtraining at the University of MassachusettsCenter for Mindfulness. Each lead instructor was assisted bya doctoral-level clinician. All instructors/clinicians com-pleted a 2-day training and received weekly or biweekly su-pervision (by senior staff at the University of Minnesota Cen-ter for Spirituality and Healing for mindfulness-based stressreduction; bydeveloper MelissaWattenberg, PhD, for present-centered group therapy).Mindfulness-Based Stress ReductionStandard protocol consists of 8 weekly 2.5-hour group ses-sions and a daylong retreat.12The intervention was modifiedtoincludeanorientationtotheprogramthat incorporatedPTSDpsychoeducation and treatment rationale (session 1), fol-lowed by 7 weekly 2.5-hour group sessions and a 6.5-hour re-treat, for a total of 9 sessions. The program teaches partici-pants toattendtothe present moment (immediate emotionaland physical states, including discomfort) in a nonjudgmen-tal and accepting way. Sessions include didactic training andformal practice in 3 meditation techniques. The body scan isaguidedexercisethat systematicallydirects attentionthroughvarious areas of the body. Sitting meditation involves devel-oping capacity for sustained self-observation through direct-CAPSClinician-Administered PTSDScaleDSM-IVDiagnostic and StatisticalManual of Mental Disorders [FourthEdition]FFMQFive Facet MindfulnessQuestionnaireMCIDminimal clinically importantdifferencePCLPTSD ChecklistPHQ-9Patient Health Questionnaire 9PTSDposttraumatic stress disorderWHOQOL-BREFWorld HealthOrganization Quality of LifeBriefMindfulness-Based Stress Reduction for PTSDAmong Veterans Original Investigation Researchjama.com (Reprinted) JAMA August 4, 2015 Volume 314, Number 5 457Copyright 2015 American Medical Association. All rights reserved.Downloaded From: http://jama.jamanetwork.com/ by a University of Ottawa Useron 08/04/2015Copyright 2015 American Medical Association. All rights reserved.ing attention to specific experiences (eg, the breath, physicalsensations, thoughts, emotions, sensorystimuli). Mindful yogainvolves gentle stretches and movements practiced withpresent-moment attention, which encourages greater bodyawareness. Meditation techniques were taught in the samemanner as is typical inprograms offeredinthecommunity, andno modifications were made to specifically accommodatePTSD. The daylong silent retreat provides an opportunity forsustained practice of these techniques. Additionally, the pro-gram encourages individuals to practice meditation tech-niques at home and to cultivate present-moment awarenessin ordinary daily activities (eg, mindful eating and driving).Present-Centered Group TherapyPresent-centered group therapy is an active-control condi-tionshowntobenefit individuals withPTSD.18,19It controls fornonspecific therapeutic factors byprovidingprofessional con-tact, a credible therapeutic rationale, and corresponding spe-cific ingredients (eg, problem solving) for reducing distress,withpositive therapeutic expectancy similar to mindfulness-basedstress reduction.13Theinterventionconsists of 9weekly1.5-hour group sessions focused on current life problems asmanifestations of PTSD.20Session1 focuses onproviding psy-choeducation about PTSD and treatment rationale, buildinggroup cohesion, and goal setting. Sessions 2 through 8 focuson discussing daily difficulties. Session 9 focuses on review-ing accomplishments and planning for the future. Therapistsarenondirectiveandencouragepatients toprovideeachotherwith support, problemsolving, and validation. There was nodiscussion of mindfulness meditation techniques or trau-matic experiences.Primary OutcomeThe primary outcome, change in PTSD symptom severityover time, was assessed using the PTSD Checklist21(PCL;range, 17-85; higher scores indicate more severe symptoms)at all assessment points (baseline and weeks 3, 6, 9, and 17).It has excellent internal consistency (Cronbach = 0.94-0.97), test-retest reliability (0.96), and concurrent validity.22The minimal clinically important difference (MCID) for self-reported PTSD symptomseverity is a reduction of 10 or morepoints on the PCL.23Secondary OutcomesDiagnosis and symptom severity of PTSD were also assessedusing the Clinician-Administered PTSDScale (CAPS)16beforeand after treatment and at 2-month follow-up (baseline,week 9, and week 17). Potentially traumatic events wereidentified using the Life Events Checklist and further as-sessedduringinterview.24Weusedtherecommended1/2scor-ing rule, wherebya frequencyscore of 1 (0 = none of the time;4 = most or all of the time) and intensity score of 2 (0 = none;4 = extreme) isrequiredtoconsider eachsymptomaspresent.22Diagnoses were based on DSM-IVcriteria for PTSD; a severityscore was also calculated by summing frequency and inten-sity scores for all 17 symptoms (range, 0-136; higher scores in-dicate more severe PTSD). Areduction of 10 or more points isconsidered the MCID for the CAPS.5Comorbid depressionsymptoms were assessed using the Patient Health Question-naire925(PHQ-9; range, 0-27; higher scoresindicatemoresymp-toms). The MCID for the PHQ-9 is a reduction of 5 or morepoints.26Quality of life was assessed using the World HealthOrganization Quality of LifeBrief (WHOQOL-BREF).27Thisstudy reports the summed total score (range, 0-130; higherscores indicate greater quality of life).Mindfulness skills (observing, describing, acting withawareness, nonjudging of inner experience, and nonreactiv-ity to inner experience) were assessed using the Five FacetMindfulness Questionnaire (FFMQ)28at all assessment points(range, 39-195; higher scores indicate greater mindfulness).Participants beliefs about the rationale and logic of thetreatment (credibility scale range, 1-9; higher scores indicatemore rationality/logic) and likelihood of the treatments suc-cess (expectancy scale range, 1-9; higher scores indicategreater expectations of success) in reducing PTSD symp-toms were assessed using the Credibility/ExpectancyQuestionnaire29at week 3. Participants reported treatmentsatisfaction at week 9 using a scale ranging from 1 to 4 withhigher scales indicating greater satisfaction. Demographicinformation, including self-reported race/ethnicity, was col-lected at baseline to characterize the sample. Mental healthtreatment history and psychotherapy health care visits (in-dividual and group therapy delivered both in specialty PTSDand mental health clinics) from October 1, 1999, to partici-pants baseline dates were extracted from VA electronicmedical records. We determined the mean duration (inmonths) of previous mental health care, total number ofpsychotherapy mental health visits, and whether a partici-pant had previously received 8 or more therapy sessions atbaseline.Treatment FidelityAll treatment sessions were videotaped. Two senior clini-cians independent of treatment delivery rated 10% of ses-sions from each condition using a rating tool adapted fromother trials of PTSD group treatment.30Data AnalysisIntention-to-treat analyses were conducted for all outcomes.Baseline differences between groups were examined usinganalysis of variance for continuously measured variables and2statistics for noncontinuous variables. Mixed-effects mod-els were used to analyze the efficacy of mindfulness-basedstress reduction compared with present-centered grouptherapy in reducing PTSD symptoms over 9 weeks of treat-ment and at 2-month follow-up.31Mixed-effects models areflexible regression methods for incomplete repeated-measures data and allow continuous and categorical covari-ates, fixed and time-dependent covariates, and a specifica-tion of unstructured as well as structured covariance matrix.The analysis for each outcome consisted of a maximum like-lihood growth curve model that included treatment, time,and treatment time interaction as fixed effects and theintercept and slope as random effects with an unstructuredcovariance matrix. Since treatment groups are expected to besimilar at baseline, the effect of treatment is capturedResearch Original Investigation Mindfulness-Based Stress Reduction for PTSDAmong Veterans458 JAMA August 4, 2015 Volume 314, Number 5 (Reprinted) jama.comCopyright 2015 American Medical Association. All rights reserved.Downloaded From: http://jama.jamanetwork.com/ by a University of Ottawa Useron 08/04/2015Copyright 2015 American Medical Association. All rights reserved.through the treatment time interaction (ie, differentialtemporal patterns of PTSD symptoms for 2 treatmentgroups). Between-group effect sizes were computed asCohen d, the standardized mean difference,32and defined assmall (d = 0.25), medium (d = 0.50), and large (d = 0.80). Wecalculated the percentage of participants who showed clini-cally significant improvement on primary and secondary out-comes based on MCIDs established in the literature. Finally,because of the sex imbalance between the groups, we alsoconducted a series of exploratory growth curve models add-ing sex as a control variable to determine the effect of thisimbalance on study findings.Power analyses were based on expected effect sizes (0.5-0.9) drawn from a prior pilot study33and estimates formeans, standard deviations, and covariances from anunpublished open trial of mindfulness-based stress reduc-tion in a group of 24 veterans with PTSD. Power analyseswere conducted for the primary outcome (PCL score) usingNquery Advisor 4 (Statistics Solutions) under the followingassumptions: (1) repeated-measures analysis of variancewith main effects of treatment (mindfulness-based stressreduction vs present-centered group therapy), time (0, 3, 6,9, and 17 weeks), and treatment time interaction; (2) com-pound symmetric covariance matrix; and (3)