1 258 192 ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME (RLS): STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: RESTLESS LEGS SYNDROME (RLS) IS A COMMON AND BURDENSOME SLEEP DISORDER ASSOCIATED WITH PROFOUND IMPAIRMENT OF HEALTH, WELL-BEING, AND QUALITY OF LIFE. UNFORTUNATELY, THE MEDICATIONS USED FOR RLS MANAGEMENT CARRY RISK OF SERIOUS SIDE EFFECTS, INCLUDING AUGMENTATION OF SYMPTOMS. YOGA, AN ANCIENT MIND-BODY DISCIPLINE DESIGNED TO PROMOTE PHYSICAL, EMOTIONAL, AND MENTAL WELL-BEING, MAY OFFER A VIABLE, LOW-RISK NEW TREATMENT. THE PRIMARY OBJECTIVES OF THIS PILOT, PARALLEL-ARM, RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO ASSESS THE ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RLS. METHODS: FORTY-FOUR ADULTS WITH CONFIRMED MODERATE TO SEVERE RLS WILL BE RECRUITED AND RANDOMIZED TO A 12-WEEK YOGA (N = 22) OR STANDARDIZED EDUCATIONAL FILM PROGRAM (N = 22). YOGA GROUP PARTICIPANTS WILL ATTEND TWO 75-MIN IYENGAR YOGA CLASSES PER WEEK FOR THE FIRST 4 WEEKS, THEN ONE 75-MIN CLASS PER WEEK FOR THE REMAINING 8 WEEKS, AND WILL COMPLETE A 30-MIN HOMEWORK ROUTINE ON NON-CLASS DAYS. EDUCATIONAL FILM GROUP PARTICIPANTS WILL ATTEND ONE 75-MIN CLASS PER WEEK FOR 12 WEEKS AND COMPLETE A DAILY RLS TREATMENT LOG; CLASSES WILL INCLUDE INFORMATION ON: RLS MANAGEMENT, INCLUDING SLEEP HYGIENE PRACTICES; OTHER SLEEP DISORDERS; AND COMPLEMENTARY THERAPIES LIKELY TO BE OF INTEREST TO THOSE PARTICIPATING IN A YOGA AND SLEEP EDUCATION STUDY. YOGA AND TREATMENT LOGS WILL BE COLLECTED WEEKLY. FEASIBILITY OUTCOMES WILL INCLUDE RECRUITMENT, ENROLLMENT, AND RANDOMIZATION RATES, RETENTION, ADHERENCE, AND PROGRAM SATISFACTION. PROGRAM EVALUATION AND YOGA-DOSING QUESTIONNAIRES WILL BE COLLECTED AT WEEK 12; DATA ON EXPLORATORY OUTCOMES (E.G., RLS SYMPTOM SEVERITY (IRLS), SLEEP QUALITY (PSQI), MOOD (POMS, PSS), AND HEALTH-RELATED QUALITY OF LIFE (SF-36)) WILL BE GATHERED AT BASELINE AND WEEK 12. DISCUSSION: THIS STUDY WILL LAY THE ESSENTIAL GROUNDWORK FOR A PLANNED LARGER RCT TO DETERMINE THE EFFICACY OF A YOGA PROGRAM FOR REDUCING SYMPTOMS AND ASSOCIATED BURDEN OF RLS. IF THE FINDINGS OF THE CURRENT TRIAL AND THE SUBSEQUENT LARGER RCTS ARE POSITIVE, THIS STUDY WILL ALSO HELP SUPPORT A NEW APPROACH TO CLINICAL TREATMENT OF THIS CHALLENGING DISORDER, HELP FOSTER IMPROVED UNDERSTANDING OF RLS ETIOLOGY, AND ULTIMATELY CONTRIBUTE TO REDUCING THE INDIVIDUAL, SOCIETAL, AND ECONOMIC BURDEN ASSOCIATED WITH THIS CONDITION. TRIAL REGISTRATION: CLINICALTRIALS.GOV, ID: NCT03570515 . RETROSPECTIVELY REGISTERED ON 1 FEBRUARY 2017. 2019 2 312 88 AN EXPLORATORY RANDOMIZED CONTROLLED TRIAL OF A 12-WEEK YOGA VERSUS EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME: FEASIBILITY AND ACCEPTABILITY. OBJECTIVES: THE PRIMARY OBJECTIVES OF THIS PILOT TRIAL WERE TO ASSESS THE STUDY FEASIBILITY AND ACCEPTABILITY OF THE 12-WEEK YOGA AND EDUCATIONAL FILM PROGRAMS FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME (RLS) IN PREPARATION FOR A FUTURE RANDOMIZED CONTROLLED TRIAL (RCT). MATERIALS AND METHODS: THIS PILOT, PARALLEL-ARM, RANDOMIZED FEASIBILITY TRIAL WAS CONDUCTED AT TWO SITES, MORGANTOWN, WV AND COLUMBUS, OH. YOGA GROUP PARTICIPANTS ATTENDED 75-MIN IYENGAR YOGA CLASSES, TWICE WEEKLY FOR 4 WEEKS, THEN ONCE A WEEK FOR 8 WEEKS (16 TOTAL CLASSES), AND COMPLETED A 30-MIN HOMEWORK ROUTINE ON NONCLASS DAYS. EDUCATIONAL FILM GROUP PARTICIPANTS ATTENDED ONCE WEEKLY, 75-MIN CLASSES (12 TOTAL CLASSES), WHICH INCLUDED INFORMATION ON RLS AND OTHER SLEEP DISORDERS, RLS MANAGEMENT INCLUDING SLEEP HYGIENE PRACTICES, AND COMPLEMENTARY THERAPIES. FEASIBILITY AND ACCEPTABILITY OUTCOMES INCLUDED PROGRAM SATISFACTION AND RECRUITMENT, RETENTION, AND ADHERENCE RATES. IN ADDITION, PARTICIPANTS WERE ASKED THEIR PREFERENCES REGARDING THREE YOGA CLASS SCHEDULE SCENARIOS FOR A FUTURE STUDY. ATTENDANCE, YOGA, AND TREATMENT LOGS WERE COLLECTED WEEKLY. PROGRAM EVALUATION AND YOGA SCHEDULING QUESTIONNAIRES WERE COLLECTED AT WEEK 12. RESULTS: FORTY-ONE ADULTS WITH MODERATE TO SEVERE RLS WERE RANDOMIZED TO A 12-WEEK YOGA (N = 19) OR EDUCATIONAL FILM (N = 22) PROGRAM. THIRTY PARTICIPANTS (73%) COMPLETED THE PROGRAM. YOGA AND EDUCATION GROUP PARTICIPANTS ATTENDED AN AVERAGE OF 13.0 +/- 0.84 (81%) AND 10.3 +/- 0.3 CLASSES (85%), RESPECTIVELY. PARTICIPANTS FROM BOTH GROUPS INDICATED SATISFACTION WITH THE STUDY. ALL YOGA GROUP RESPONDENTS TO THE PROGRAM EVALUATION REPORTED THEY WOULD LIKELY (N = 6) OR VERY LIKELY (N = 7) CONTINUE YOGA PRACTICE; 86.7% OF EDUCATION GROUP RESPONDENTS (13 OF 15) INDICATED THAT THEY WERE LIKELY (N = 7) OR VERY LIKELY (N = 6) TO MAKE LASTING CHANGES BASED ON WHAT THEY HAD LEARNED. THE PREFERRED SCHEDULE FOR A FUTURE STUDY WAS A 16-WEEK STUDY WITH ONCE-WEEKLY YOGA CLASSES. CONCLUSIONS: THE FINDINGS OF THIS STUDY SUGGEST THAT A LARGER RCT COMPARING YOGA WITH AN EDUCATIONAL FILM GROUP FOR THE MANAGEMENT OF RLS IS FEASIBLE. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT03570515; 02/01/2017. 2022 3 2323 46 TREATMENT OF CHRONIC PRIMARY SLEEP ONSET INSOMNIA WITH KUNDALINI YOGA: A RANDOMIZED CONTROLLED TRIAL WITH ACTIVE SLEEP HYGIENE COMPARISON. STUDY OBJECTIVES: PRIOR STUDIES HAVE SUGGESTED A BENEFIT OF YOGA FOR ALLEVIATING SLEEP DISTURBANCE; HOWEVER, MANY STUDIES HAVE HAD METHODOLOGICAL LIMITATIONS. THIS TRIAL STUDY AIMED TO EXTEND THAT LITERATURE BY INCLUDING AN ACTIVE SLEEP HYGIENE COMPARISON. METHODS: PARTICIPANTS AGED 25-59 YEARS WITH A PRIMARY COMPLAINT OF SLEEP ONSET INSOMNIA LASTING AT LEAST 6 MONTHS WERE BLOCK RANDOMIZED TO AN 8-WEEK KUNDALINI YOGA OR SLEEP HYGIENE INTERVENTION, BOTH CONSISTING OF INITIAL 60-MINUTE INSTRUCTION AND WEEKLY CHECK-INS. DAILY SLEEP DIARIES AND QUESTIONNAIRES WERE COLLECTED AT BASELINE, THROUGHOUT THE INTERVENTION, AND AT 6-MONTH FOLLOW-UP. DATA WERE ANALYZED USING LINEAR MIXED MODELS (N = 20 IN EACH GROUP). RESULTS: PARTICIPANT RATINGS OF THE INTERVENTIONS DID NOT SIGNIFICANTLY DIFFER. SLEEP HYGIENE IMPROVED SEVERAL DIARY AND QUESTIONNAIRE OUTCOMES, HOWEVER, YOGA RESULTED IN EVEN GREATER IMPROVEMENTS CORRESPONDING TO MEDIUM-TO-LARGE BETWEEN-GROUP EFFECT SIZES. TOTAL SLEEP TIME INCREASED PROGRESSIVELY ACROSS YOGA TREATMENT (D = 0.95, P = .002), CONCURRENT WITH INCREASED SLEEP EFFICIENCY (D = 1.36, P < .001) AND DECREASED SLEEP ONSET LATENCY (D = -1.16, P < .001), BUT WITHOUT CHANGES IN PRE-SLEEP AROUSAL (D =-0.30, P = .59). REMISSION RATES WERE ALSO HIGHER FOR YOGA COMPARED TO SLEEP HYGIENE, WITH >/= 80% OF YOGA PARTICIPANTS REPORTING AVERAGE SLEEP ONSET LATENCY < 30 MINUTES AND SLEEP EFFICIENCY > 80% AT 6-MONTH FOLLOW-UP. FOR OVER 50% OF YOGA PARTICIPANTS, THE INSOMNIA SEVERITY INDEX DECREASED BY AT LEAST 8 POINTS AT END OF TREATMENT AND FOLLOW-UP. CONCLUSIONS: YOGA, TAUGHT IN A SELF-CARE FRAMEWORK WITH MINIMAL INSTRUCTOR BURDEN, WAS ASSOCIATED WITH SELF-REPORTED IMPROVEMENTS ABOVE AND BEYOND AN ACTIVE SLEEP HYGIENE COMPARISON, SUSTAINED AT 6-MONTH FOLLOW-UP. FOLLOW-UP STUDIES ARE NEEDED TO ASSESS ACTIGRAPHY AND POLYSOMNOGRAPHY OUTCOMES, AS WELL AS POSSIBLE MECHANISMS OF CHANGE. CLINICAL TRIAL REGISTRATION: REGISTRY: CLINICALTRIALS.GOV; NAME: YOGA AS A TREATMENT FOR INSOMNIA; URL: HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT00033865; IDENTIFIER: NCT00033865. CITATION: KHALSA SBS, GOLDSTEIN MR. TREATMENT OF CHRONIC PRIMARY SLEEP ONSET INSOMNIA WITH KUNDALINI YOGA: A RANDOMIZED CONTROLLED TRIAL WITH ACTIVE SLEEP HYGIENE COMPARISON. J CLIN SLEEP MED. 2021;17(9):1841-1852. 2021 4 945 72 EFFECTS OF A 12-WEEK YOGA VERSUS A 12-WEEK EDUCATIONAL FILM INTERVENTION ON SYMPTOMS OF RESTLESS LEGS SYNDROME AND RELATED OUTCOMES: AN EXPLORATORY RANDOMIZED CONTROLLED TRIAL. STUDY OBJECTIVES: TO ASSESS THE EFFECTS OF A YOGA VERSUS EDUCATIONAL FILM (EF) PROGRAM ON RESTLESS LEGS SYNDROME (RLS) SYMPTOMS AND RELATED OUTCOMES IN ADULTS WITH RLS. METHODS: FORTY-ONE COMMUNITY-DWELLING, AMBULATORY NONPREGNANT ADULTS WITH MODERATE TO SEVERE RLS WERE RANDOMIZED TO A 12-WEEK YOGA (N = 19) OR EF PROGRAM (N = 22). IN ADDITION TO ATTENDING CLASSES, ALL PARTICIPANTS COMPLETED PRACTICE/TREATMENT LOGS. YOGA GROUP PARTICIPANTS WERE ASKED TO PRACTICE AT HOME 30 MINUTES PER DAY ON NONCLASS DAYS; EF PARTICIPANTS WERE INSTRUCTED TO RECORD ANY RLS TREATMENTS USED ON THEIR DAILY LOGS. CORE OUTCOMES ASSESSED PRETREATMENT AND POSTTREATMENT WERE RLS SYMPTOMS AND SYMPTOM SEVERITY (INTERNATIONAL RLS STUDY GROUP SCALE (IRLS) AND RLS ORDINAL SCALE), SLEEP QUALITY, MOOD, PERCEIVED STRESS, AND QUALITY OF LIFE (QOL). RESULTS: THIRTY ADULTS (13 YOGA, 17 EF), AGED 24 TO 73 (MEAN = 50.4 +/- 2.4 YEARS), COMPLETED THE 12-WEEK STUDY (78% FEMALE, 80.5% WHITE). POST-INTERVENTION, BOTH GROUPS SHOWED SIGNIFICANT IMPROVEMENT IN RLS SYMPTOMS AND SEVERITY, PERCEIVED STRESS, MOOD, AND QOL-MENTAL HEALTH (P /=12 WEEKS: YOGA (N=27), PT (N=26). METHODS: YOGA PARTICIPANTS ATTENDED A 6-WEEK, ONCE WEEKLY, 2-HOUR YOGA CLASS. PT PARTICIPANTS UNDERWENT TWICE WEEKLY, 1-HOUR INDIVIDUALIZED PT. DATA WERE COLLECTED AT BASELINE AND AT 6 WEEKS. GROUPS WERE COMPARED BY USING CHI2 AND INDEPENDENT SAMPLES T-TESTS. HIERARCHICAL LINEAR REGRESSION WAS USED TO PREDICT TREATMENT OUTCOMES. MAIN OUTCOME MEASURES: DISABILITY (ROLAND MORRIS DISABILITY QUESTIONNAIRE), HEALTH STATUS (RAND SHORT FORM 36 HEALTH SURVEY 1.0), PAIN BOTHERSOMENESS (NUMERICAL RATING SCALE), BACK PAIN SELF-EFFICACY (BACK PAIN SELF-EFFICACY SCALE), AND TREATMENT SATISFACTION. RESULTS: AT BASELINE, YOGA PARTICIPANTS WERE SIGNIFICANTLY LESS DISABLED (P=.013), HAD HIGHER HEALTH STATUS (P=.023), GREATER PAIN SELF-EFFICACY (P=.012), AND LESS AVERAGE PAIN BOTHERSOMENESS (P=.001) COMPARED WITH PT PARTICIPANTS. AT 6 WEEKS, WHEN CONTROLLING FOR BASELINE GROUP DIFFERENCES, GREATER PAIN SELF-EFFICACY WAS THE STRONGEST PREDICTOR FOR REDUCED PAIN AND HIGHER FUNCTION FOR THE ENTIRE SAMPLE. A SIGNIFICANT GROUP INTERACTION BY BASELINE PAIN SELF-EFFICACY PREDICTED DISABILITY AT 6 WEEKS. PT PARTICIPANTS WITH LOW PAIN SELF-EFFICACY REPORTED SIGNIFICANTLY GREATER DISABILITY THAN THOSE WITH HIGH PAIN SELF-EFFICACY. YOGA PARTICIPANTS WITH LOW AND HIGH PAIN SELF-EFFICACY HAD SIMILAR DISABILITY OUTCOMES. CONCLUSION: THESE FINDINGS STRENGTHEN EVIDENCE THAT SELF-EFFICACY IS ASSOCIATED WITH CLBP OUTCOMES, ESPECIALLY IN INDIVIDUALS SELF-SELECTING PT. FURTHER RESEARCH TO EVALUATE OUTCOMES AFTER YOGA AND PT IN PARTICIPANTS WITH LOW PAIN SELF-EFFICACY IS NEEDED. 2010 15 388 45 BENEFITS OF THE RESTORATIVE EXERCISE AND STRENGTH TRAINING FOR OPERATIONAL RESILIENCE AND EXCELLENCE YOGA PROGRAM FOR CHRONIC LOW BACK PAIN IN SERVICE MEMBERS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: TO EXAMINE THE FEASIBILITY AND PRELIMINARY EFFECTIVENESS OF AN INDIVIDUALIZED YOGA PROGRAM. DESIGN: PILOT RANDOMIZED CONTROLLED TRIAL. SETTING: MILITARY MEDICAL CENTER. PARTICIPANTS: PATIENTS (N=68) WITH CHRONIC LOW BACK PAIN. INTERVENTIONS: RESTORATIVE EXERCISE AND STRENGTH TRAINING FOR OPERATIONAL RESILIENCE AND EXCELLENCE (RESTORE) PROGRAM (9-12 INDIVIDUAL YOGA SESSIONS) OR TREATMENT AS USUAL (CONTROL) FOR AN 8-WEEK PERIOD. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS PAST 24-HOUR PAIN (DEFENSE & VETERANS PAIN RATING SCALE 2.0). SECONDARY OUTCOMES INCLUDED DISABILITY (ROLAND-MORRIS DISABILITY QUESTIONNAIRE) AND PHYSICAL FUNCTIONING AND SYMPTOM BURDEN (PATIENT-REPORTED OUTCOMES MEASUREMENT INFORMATION SYSTEM-29 SUBSCALES). ASSESSMENT OCCURRED AT BASELINE, WEEK 4, WEEK 8, 3-MONTH FOLLOW-UP, AND 6-MONTH FOLLOW-UP. EXPLORATORY OUTCOMES INCLUDED THE PROPORTION OF PARTICIPANTS IN EACH GROUP REPORTING CLINICALLY MEANINGFUL CHANGES AT 3- AND 6-MONTH FOLLOW-UPS. RESULTS: GENERALIZED LINEAR MIXED MODELS WITH SEQUENTIAL BONFERRONI-ADJUSTED PAIRWISE SIGNIFICANCE TESTS AND CHI-SQUARE ANALYSES EXAMINED LONGITUDINAL OUTCOMES. SECONDARY OUTCOME SIGNIFICANCE TESTS WERE BONFERRONI ADJUSTED FOR MULTIPLE OUTCOMES. THE RESTORE GROUP REPORTED IMPROVED PAIN COMPARED WITH THE CONTROL GROUP. SECONDARY OUTCOMES DID NOT RETAIN SIGNIFICANCE AFTER BONFERRONI ADJUSTMENTS FOR MULTIPLE OUTCOMES, ALTHOUGH A HIGHER PROPORTION OF RESTORE PARTICIPANTS REPORTED CLINICALLY MEANINGFULLY CHANGES IN ALL OUTCOMES AT 3-MONTH FOLLOW-UP AND IN SYMPTOM BURDEN AT 6-MONTH FOLLOW-UP. CONCLUSIONS: RESTORE MAY BE A VIABLE NONPHARMACOLOGICAL TREATMENT FOR LOW BACK PAIN WITH MINIMAL SIDE EFFECTS, AND RESEARCH EFFORTS ARE NEEDED TO COMPARE THE EFFECTIVENESS OF RESTORE DELIVERY FORMATS (EG, GROUP VS INDIVIDUAL) WITH THAT OF OTHER TREATMENT MODALITIES. 2018 16 2628 53 YOGA FOR THE MANAGEMENT OF PAIN AND SLEEP IN RHEUMATOID ARTHRITIS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: THE AIM OF THE PRESENT STUDY WAS TO DETERMINE THE FEASIBILITY OF A RELAXATION-BASED YOGA INTERVENTION FOR RHEUMATOID ARTHRITIS, DESIGNED AND REPORTED IN ACCORDANCE WITH DELPHI RECOMMENDATIONS FOR YOGA INTERVENTIONS FOR MUSCULOSKELETAL CONDITIONS. METHODS: PARTICIPANTS WERE RECRUITED FROM A HOSPITAL DATABASE, AND RANDOMIZED TO EITHER EIGHT WEEKLY 75-MIN YOGA CLASSES OR A USUAL CARE CONTROL. FEASIBILITY WAS DETERMINED BY RECRUITMENT RATES, RETENTION, PROTOCOL ADHERENCE, PARTICIPANT SATISFACTION AND ADVERSE EVENTS. SECONDARY PHYSICAL AND PSYCHOSOCIAL OUTCOMES WERE ASSESSED USING SELF-REPORTED QUESTIONNAIRES AT BASELINE (WEEK 0), WEEK 9 (PRIMARY TIME POINT) AND WEEK 12 (FOLLOW-UP). RESULTS: OVER A 3-MONTH PERIOD, 26 PARTICIPANTS WITH MILD PAIN, MILD TO MODERATE FUNCTIONAL DISABILITY AND MODERATE DISEASE ACTIVITY WERE RECRUITED INTO THE STUDY (25% RECRUITMENT RATE). RETENTION RATES WERE 100% FOR YOGA PARTICIPANTS AND 92% FOR USUAL CARE PARTICIPANTS AT BOTH WEEKS 9 AND 12. PROTOCOL ADHERENCE AND PARTICIPANT SATISFACTION WERE HIGH. YOGA PARTICIPANTS ATTENDED A MEDIAN OF SEVEN CLASSES; ADDITIONALLY, SEVEN OF THE YOGA PARTICIPANTS (54%) REPORTED CONTINUING YOGA AT HOME DURING THE FOLLOW-UP PERIOD. NO SERIOUS ADVERSE EVENTS WERE RELATED TO THE STUDY. SECONDARY OUTCOMES SHOWED NO GROUP EFFECTS OF YOGA COMPARED WITH USUAL CARE. CONCLUSIONS: A RELAXATION-BASED YOGA PROGRAMME WAS FOUND TO BE FEASIBLE AND SAFE FOR PARTICIPANTS WITH RHEUMATOID ARTHRITIS-RELATED PAIN AND FUNCTIONAL DISABILITY. ADVERSE EVENTS WERE MINOR, AND NOT UNEXPECTED FROM AN INTERVENTION INCLUDING PHYSICAL COMPONENTS. THIS PILOT PROVIDES A FRAMEWORK FOR LARGER INTERVENTION STUDIES, AND SUPPORTS FURTHER EXPLORATION OF YOGA AS A COMPLEX INTERVENTION TO ASSIST WITH THE MANAGEMENT OF RHEUMATOID ARTHRITIS. 2018 17 2604 48 YOGA FOR PERSISTENT FATIGUE IN BREAST CANCER SURVIVORS: A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CANCER-RELATED FATIGUE AFFLICTS UP TO 33% OF BREAST CANCER SURVIVORS, YET THERE ARE NO EMPIRICALLY VALIDATED TREATMENTS FOR THIS SYMPTOM. METHODS: THE AUTHORS CONDUCTED A 2-GROUP RANDOMIZED CONTROLLED TRIAL TO DETERMINE THE FEASIBILITY AND EFFICACY OF AN IYENGAR YOGA INTERVENTION FOR BREAST CANCER SURVIVORS WITH PERSISTENT POST-TREATMENT FATIGUE. PARTICIPANTS WERE BREAST CANCER SURVIVORS WHO HAD COMPLETED CANCER TREATMENTS (OTHER THAN ENDOCRINE THERAPY) AT LEAST 6 MONTHS BEFORE ENROLLMENT, REPORTED SIGNIFICANT CANCER-RELATED FATIGUE, AND HAD NO OTHER MEDICAL CONDITIONS THAT WOULD ACCOUNT FOR FATIGUE SYMPTOMS OR INTERFERE WITH YOGA PRACTICE. BLOCK RANDOMIZATION WAS USED TO ASSIGN PARTICIPANTS TO A 12-WEEK, IYENGAR-BASED YOGA INTERVENTION OR TO 12 WEEKS OF HEALTH EDUCATION (CONTROL). THE PRIMARY OUTCOME WAS CHANGE IN FATIGUE MEASURED AT BASELINE, IMMEDIATELY POST-TREATMENT, AND 3 MONTHS AFTER TREATMENT COMPLETION. ADDITIONAL OUTCOMES INCLUDED CHANGES IN VIGOR, DEPRESSIVE SYMPTOMS, SLEEP, PERCEIVED STRESS, AND PHYSICAL PERFORMANCE. INTENT-TO-TREAT ANALYSES WERE CONDUCTED WITH ALL RANDOMIZED PARTICIPANTS USING LINEAR MIXED MODELS. RESULTS: THIRTY-ONE WOMEN WERE RANDOMLY ASSIGNED TO YOGA (N = 16) OR HEALTH EDUCATION (N = 15). FATIGUE SEVERITY DECLINED SIGNIFICANTLY FROM BASELINE TO POST-TREATMENT AND OVER A 3-MONTH FOLLOW-UP IN THE YOGA GROUP RELATIVE TO CONTROLS (P = .032). IN ADDITION, THE YOGA GROUP HAD SIGNIFICANT INCREASES IN VIGOR RELATIVE TO CONTROLS (P = .011). BOTH GROUPS HAD POSITIVE CHANGES IN DEPRESSIVE SYMPTOMS AND PERCEIVED STRESS (P < .05). NO SIGNIFICANT CHANGES IN SLEEP OR PHYSICAL PERFORMANCE WERE OBSERVED. CONCLUSIONS: A TARGETED YOGA INTERVENTION LED TO SIGNIFICANT IMPROVEMENTS IN FATIGUE AND VIGOR AMONG BREAST CANCER SURVIVORS WITH PERSISTENT FATIGUE SYMPTOMS. 2012 18 1541 34 KRIPALU YOGA FOR MILITARY VETERANS WITH PTSD: A RANDOMIZED TRIAL. OBJECTIVES: THIS RANDOMIZED CONTROLLED TRIAL OF YOGA FOR MILITARY VETERANS AND ACTIVE DUTY PERSONNEL WITH POSTTRAUMATIC STRESS DISORDER (PTSD) EVALUATED THE EFFICACY OF A 10-WEEK YOGA INTERVENTION ON PTSD. METHOD: FIFTY-ONE PARTICIPANTS WERE RANDOMIZED INTO YOGA OR NO-TREATMENT ASSESSMENT-ONLY CONTROL GROUPS. PRIMARY OUTCOME MEASURES INCLUDED QUESTIONNAIRES AND THE CLINICIAN ADMINISTERED PTSD SCALE. RESULTS: BOTH YOGA (N = 9) AND CONTROL (N = 6) PARTICIPANTS SHOWED SIGNIFICANT DECREASES IN REEXPERIENCING SYMPTOMS, WITH NO SIGNIFICANT BETWEEN-GROUP DIFFERENCES. SECONDARY WITHIN-GROUP ANALYSES OF A SELF-SELECTED WAIT-LIST YOGA GROUP (N = 7) SHOWED SIGNIFICANT REDUCTIONS IN PTSD SYMPTOMS AFTER YOGA PARTICIPATION, IN CONTRAST TO THEIR CONTROL GROUP PARTICIPATION. CONSISTENT WITH CURRENT LITERATURE REGARDING HIGH RATES OF PTSD TREATMENT DROPOUT FOR VETERANS, THIS STUDY FACED CHALLENGES RETAINING PARTICIPANTS ACROSS CONDITIONS. CONCLUSION: THESE RESULTS ARE CONSISTENT WITH RECENT LITERATURE INDICATING THAT YOGA MAY HAVE POTENTIAL AS A PTSD THERAPY IN A VETERAN OR MILITARY POPULATION. HOWEVER, ADDITIONAL LARGER SAMPLE SIZE TRIALS ARE NECESSARY TO CONFIRM THIS CONCLUSION. 2018 19 743 40 EFFECT OF RESTORATIVE YOGA VS. STRETCHING ON DIURNAL CORTISOL DYNAMICS AND PSYCHOSOCIAL OUTCOMES IN INDIVIDUALS WITH THE METABOLIC SYNDROME: THE PRYSMS RANDOMIZED CONTROLLED TRIAL. PURPOSE: CHRONIC STIMULATION AND DYSREGULATION OF THE NEUROENDOCRINE SYSTEM BY STRESS MAY CAUSE METABOLIC ABNORMALITIES. WE ESTIMATED HOW MUCH CORTISOL AND PSYCHOSOCIAL OUTCOMES IMPROVED WITH A RESTORATIVE YOGA (RELAXATION) VERSUS A LOW IMPACT STRETCHING INTERVENTION FOR INDIVIDUALS WITH THE METABOLIC SYNDROME. METHODS: WE CONDUCTED A 1-YEAR MULTI-CENTER RANDOMIZED CONTROLLED TRIAL (6-MONTH INTERVENTION AND 6-MONTH MAINTENANCE PHASE) OF RESTORATIVE YOGA VS. STRETCHING. PARTICIPANTS COMPLETED SURVEYS TO ASSESS DEPRESSION, SOCIAL SUPPORT, POSITIVE AFFECT, AND STRESS AT BASELINE, 6 MONTHS AND 12 MONTHS. FOR EACH ASSESSMENT, WE COLLECTED SALIVA AT FOUR POINTS DAILY FOR THREE DAYS AND COLLECTED RESPONSE TO DEXAMETHASONE ON THE FOURTH DAY FOR ANALYSIS OF DIURNAL CORTISOL DYNAMICS. WE ANALYZED OUR DATA USING MULTIVARIATE REGRESSION MODELS, CONTROLLING FOR STUDY SITE, MEDICATIONS (ANTIDEPRESSANTS, HORMONE THERAPY), BODY MASS INDEX, AND BASELINE CORTISOL VALUES. RESULTS: PSYCHOSOCIAL OUTCOME MEASURES WERE AVAILABLE FOR 171 STUDY PARTICIPANTS AT BASELINE, 140 AT 6 MONTHS, AND 132 AT 1 YEAR. COMPLETE CORTISOL DATA WERE AVAILABLE FOR 136 OF 171 STUDY PARTICIPANTS (72 IN RESTORATIVE YOGA AND 64 IN STRETCHING) AND WERE ONLY AVAILABLE AT BASELINE AND 6 MONTHS. AT 6 MONTHS, THE STRETCHING GROUP HAD DECREASED CORTISOL AT WAKING AND BEDTIME COMPARED TO THE RESTORATIVE YOGA GROUP. THE PATTERN OF CHANGES IN STRESS MIRRORED THIS IMPROVEMENT, WITH THE STRETCHING GROUP SHOWING REDUCTIONS IN CHRONIC STRESS SEVERITY AND PERSEVERATIVE THOUGHTS ABOUT THEIR STRESS. PERCEIVED STRESS DECREASED BY 1.5 POINTS (-0.4; 3.3, P=0.11) AT 6 MONTHS, AND BY 2.0 POINTS (0.1; 3.9, P=0.04) AT 1 YEAR IN THE STRETCHING COMPARED TO RESTORATIVE YOGA GROUPS. POST HOC ANALYSES SUGGEST THAT IN THE STRETCHING GROUP ONLY, PERCEIVED INCREASES IN SOCIAL SUPPORT (PARTICULARLY FEELINGS OF BELONGING), BUT NOT CHANGES IN STRESS WERE RELATED TO IMPROVED CORTISOL DYNAMICS. CONCLUSIONS: WE FOUND SIGNIFICANT DECREASES IN SALIVARY CORTISOL, CHRONIC STRESS SEVERITY, AND STRESS PERCEPTION IN THE STRETCHING GROUP COMPARED TO THE RESTORATIVE YOGA GROUP. GROUP SUPPORT DURING THE INTERACTIVE STRETCH CLASSES MAY HAVE CONTRIBUTED TO THESE CHANGES. 2014 20 2320 44 TREATMENT CREDIBILITY, EXPECTANCY, AND PREFERENCE: PREDICTION OF TREATMENT ENGAGEMENT AND OUTCOME IN A RANDOMIZED CLINICAL TRIAL OF HATHA YOGA VS. HEALTH EDUCATION AS ADJUNCT TREATMENTS FOR DEPRESSION. BACKGROUND: HATHA YOGA MAY BE HELPFUL FOR ALLEVIATING DEPRESSION SYMPTOMS. THE PURPOSE OF THIS ANALYSIS IS TO DETERMINE WHETHER TREATMENT PROGRAM PREFERENCE, CREDIBILITY, OR EXPECTANCY PREDICT ENGAGEMENT IN DEPRESSION INTERVENTIONS (YOGA OR A CONTROL CLASS) OR DEPRESSION SYMPTOM SEVERITY OVER TIME. METHODS: THIS IS A SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL (RCT) OF HATHA YOGA VS. A HEALTH EDUCATION CONTROL GROUP FOR TREATMENT OF DEPRESSION. DEPRESSED PARTICIPANTS (N=122) ATTENDED UP TO 20 CLASSES OVER A PERIOD OF 10 WEEKS, AND THEN COMPLETED ADDITIONAL ASSESSMENTS AFTER 3 AND 6 MONTHS. WE ASSESSED TREATMENT PREFERENCE PRIOR TO RANDOMIZATION, AND TREATMENT CREDIBILITY AND EXPECTANCY AFTER PARTICIPANTS ATTENDED THEIR FIRST CLASS. TREATMENT "CONCORDANCE" INDICATED THAT TREATMENT PREFERENCE MATCHED ASSIGNED TREATMENT. RESULTS: TREATMENT CREDIBILITY, EXPECTANCY, AND CONCORDANCE WERE NOT ASSOCIATED WITH TREATMENT ENGAGEMENT. TREATMENT EXPECTANCY MODERATED THE ASSOCIATION BETWEEN TREATMENT GROUP AND DEPRESSION. DEPRESSION SEVERITY OVER TIME DIFFERED BY EXPECTANCY LEVEL FOR THE YOGA GROUP BUT NOT FOR THE HEALTH EDUCATION GROUP. CONTROLLING FOR BASELINE DEPRESSION, PARTICIPANTS IN THE YOGA GROUP WITH AN AVERAGE OR HIGH EXPECTANCY FOR IMPROVEMENT SHOWED LOWER DEPRESSION SYMPTOMS ACROSS THE ACUTE INTERVENTION AND FOLLOW-UP PERIOD THAN THOSE WITH A LOW EXPECTANCY FOR IMPROVEMENT. THERE WAS A TREND FOR A SIMILAR PATTERN FOR CREDIBILITY. CONCORDANCE WAS NOT ASSOCIATED WITH TREATMENT OUTCOME. LIMITATIONS: THIS IS A SECONDARY, POST-HOC ANALYSIS AND SHOULD BE CONSIDERED HYPOTHESIS-GENERATING. CONCLUSIONS: RESULTS SUGGEST THAT EXPECTANCY IMPROVES THE LIKELIHOOD OF SUCCESS ONLY FOR A INTERVENTION THOUGHT TO ACTIVELY TARGET DEPRESSION (YOGA) AND NOT A CONTROL INTERVENTION. 2018