1  217 187 A STUDY PROTOCOL OF A THREE-GROUP RANDOMIZED FEASIBILITY TRIAL OF AN ONLINE YOGA INTERVENTION FOR MOTHERS AFTER STILLBIRTH (THE MINDFUL HEALTH STUDY). BACKGROUND: IN THE USA, STILLBIRTH (IN UTERO FETAL DEATH >/=20 WEEKS GESTATION) IS A MAJOR PUBLIC HEALTH ISSUE. WOMEN WHO EXPERIENCE STILLBIRTH, COMPARED TO WOMEN WITH LIVE BIRTH, HAVE A NEARLY SEVENFOLD INCREASED RISK OF A POSITIVE SCREEN FOR POST-TRAUMATIC STRESS DISORDER (PTSD) AND A FOURFOLD INCREASED RISK OF DEPRESSIVE SYMPTOMS. BECAUSE THE MAJORITY OF WOMEN WHO HAVE EXPERIENCED THE DEATH OF THEIR BABY BECOME PREGNANT WITHIN 12-18 MONTHS AND THE LACK OF INTERVENTION STUDIES CONDUCTED WITHIN THIS POPULATION, NOVEL APPROACHES TARGETING PHYSICAL AND MENTAL HEALTH, SPECIFIC TO THE NEEDS OF THIS POPULATION, ARE CRITICAL. EVIDENCE SUGGESTS THAT YOGA IS EFFICACIOUS, SAFE, ACCEPTABLE, AND COST-EFFECTIVE FOR IMPROVING MENTAL HEALTH IN A VARIETY OF POPULATIONS, INCLUDING PREGNANT AND POSTPARTUM WOMEN. TO DATE, THERE ARE NO KNOWN STUDIES EXAMINING ONLINE-STREAMING YOGA AS A STRATEGY TO HELP MOTHERS COPE WITH PTSD SYMPTOMS AFTER STILLBIRTH. METHODS: THE PRESENT STUDY IS A TWO-PHASE RANDOMIZED CONTROLLED TRIAL. PHASE 1 WILL INVOLVE (1) AN ITERATIVE DESIGN PROCESS TO DEVELOP THE ONLINE YOGA PRESCRIPTION FOR PHASE 2 AND (2) QUALITATIVE INTERVIEWS TO IDENTIFY CULTURAL BARRIERS TO RECRUITMENT IN NON-CAUCASIAN WOMEN (I.E., PREDOMINATELY HISPANIC AND/OR AFRICAN AMERICAN) WHO HAVE EXPERIENCED STILLBIRTH (N = 5). PHASE 2 IS A THREE-GROUP RANDOMIZED FEASIBILITY TRIAL WITH ASSESSMENTS AT BASELINE, AND AT 12 AND 20 WEEKS POST-INTERVENTION. NINETY WOMEN WHO HAVE EXPERIENCED A STILLBIRTH WITHIN 6 WEEKS TO 24 MONTHS WILL BE RANDOMIZED INTO ONE OF THE FOLLOWING THREE ARMS FOR 12 WEEKS: (1) INTERVENTION LOW DOSE (LD) = 60 MIN/WEEK ONLINE-STREAMING YOGA (N = 30), (2) INTERVENTION MODERATE DOSE (MD) = 150 MIN/WEEK ONLINE-STREAMING YOGA (N = 30), OR (3) STRETCH AND TONE CONTROL (STC) GROUP = 60 MIN/WEEK OF STRETCHING/TONING EXERCISES (N = 30). DISCUSSION: THIS STUDY WILL EXPLORE THE FEASIBILITY AND ACCEPTABILITY OF A 12-WEEK, HOME-BASED, ONLINE-STREAMED YOGA INTERVENTION, WITH VARYING DOSES AMONG MOTHERS AFTER A STILLBIRTH. IF FEASIBLE, THE FINDINGS FROM THIS STUDY WILL INFORM A FULL-SCALE TRIAL TO DETERMINE THE EFFECTIVENESS OF HOME-BASED ONLINE-STREAMED YOGA TO IMPROVE PTSD. LONG-TERM, HEALTH CARE PROVIDERS COULD USE ONLINE YOGA AS A NON-PHARMACEUTICAL, INEXPENSIVE RESOURCE FOR STILLBIRTH AFTERCARE. TRIAL REGISTRATION: NCT02925481.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                              
2 1683  70 ONLINE YOGA TO REDUCE POST TRAUMATIC STRESS IN WOMEN WHO HAVE EXPERIENCED STILLBIRTH: A RANDOMIZED CONTROL FEASIBILITY TRIAL. BACKGROUND: ABOUT 1 IN EVERY 150 PREGNANCIES END IN STILLBIRTH. CONSEQUENCES INCLUDE SYMPTOMS OF POST TRAUMATIC STRESS DISORDER (PTSD), DEPRESSION, AND ANXIETY. YOGA HAS BEEN USED TO TREAT PTSD IN OTHER POPULATIONS AND MAY IMPROVE HEALTH OUTCOMES FOR STILLBIRTH MOTHERS. THE PURPOSE OF THIS STUDY WAS TO DETERMINE: (A) FEASIBILITY OF A 12-WEEK HOME-BASED, ONLINE YOGA INTERVENTION WITH VARYING DOSES; (B) ACCEPTABILITY OF A "STRETCH AND TONE" CONTROL GROUP; AND (C) PRELIMINARY EFFICACY OF THE INTERVENTION ON REDUCING SYMPTOMS OF PTSD, ANXIETY, DEPRESSION, PERINATAL GRIEF, SELF-COMPASSION, EMOTIONAL REGULATION, MINDFULNESS, SLEEP QUALITY, AND SUBJECTIVE HEALTH. METHODS: PARTICIPANTS (N = 90) WERE RECRUITED NATIONALLY AND RANDOMIZED INTO ONE OF THREE GROUPS FOR YOGA OR EXERCISE (LOW DOSE (LD), 60 MIN PER WEEK; MODERATE DOSE (MD), 150 MIN PER WEEK; AND STRETCH-AND-TONE CONTROL GROUP (STC)). BASELINE AND POST-INTERVENTION SURVEYS MEASURED MAIN OUTCOMES (LISTED ABOVE). FREQUENCY ANALYSES WERE USED TO DETERMINE FEASIBILITY. REPEATED MEASURES ANCOVA WERE USED TO DETERMINE PRELIMINARY EFFICACY. MULTIPLE REGRESSION ANALYSES WERE USED TO DETERMINE A DOSE-RESPONSE RELATIONSHIP BETWEEN MINUTES OF YOGA AND EACH OUTCOME VARIABLE. RESULTS: OVER HALF OF PARTICIPANTS COMPLETED THE INTERVENTION (N = 48/90). BENCHMARKS (>/=70% REPORTED > 75% SATISFACTION) WERE MET IN EACH GROUP FOR SATISFACTION AND ENJOYMENT. PARTICIPANTS MEETING BENCHMARKS (COMPLETING > 90% OF PRESCRIBED MINUTES 9/12 WEEKS) FOR LD AND MD GROUPS WERE 44% (N = 8/18) AND 6% (N = 1/16), RESPECTIVELY. LD AND MD GROUPS AVERAGED 44.0 AND 77.3 MIN PER WEEK OF YOGA, RESPECTIVELY. THE MD GROUP REPORTED THAT 150 PRESCRIBED MINUTES PER WEEK OF YOGA WAS TOO MUCH. THERE WERE SIGNIFICANT DECREASES IN PTSD AND DEPRESSION, AND IMPROVEMENTS IN SELF-RATED HEALTH AT POST-INTERVENTION FOR BOTH INTERVENTION GROUPS. THERE WAS A SIGNIFICANT DIFFERENCE IN DEPRESSION SCORES (P = .036) AND GRIEF INTENSITY (P = .009) BETWEEN THE MD AND STC GROUPS. PTSD SHOWED NON-SIGNIFICANT DECREASES OF 43% AND 56% AT POST-INTERVENTION IN LD AND MD GROUPS, RESPECTIVELY (22% DECREASE IN CONTROL). CONCLUSIONS: THIS WAS THE FIRST STUDY TO DETERMINE THE FEASIBILITY AND PRELIMINARY EFFICACY OF AN ONLINE YOGA INTERVENTION FOR WOMEN AFTER STILLBIRTH. FUTURE RESEARCH WARRANTS A RANDOMIZED CONTROLLED TRIAL. TRIAL REGISTRATION: CLINICALTRIALS.GOV. NCT02925481. REGISTERED 10-04-16.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                    
3 1207  48 EXPERIENCES OF WOMEN WHO PARTICIPATED IN A BETA-TEST FOR AN ONLINE-STREAMED YOGA INTERVENTION AFTER A STILLBIRTH. BACKGROUND: LITTLE IS KNOWN ABOUT HOW TO BEST CARE FOR MOTHERS AFTER STILLBIRTH. AS SUCH, THIS PAPER WILL REPORT THE SATISFACTION AND PERCEPTIONS OF AN ONLINE YOGA INTERVENTION (12-WEEK BETA TEST) IN WOMEN AFTER STILLBIRTH. METHODS: PARTICIPANTS (N=74) HAD A STILLBIRTH WITHIN THE LAST 24-MONTHS (M TIME SINCE LOSS 9.65 +/- 6.9 MONTHS). POST-INTERVENTION SATISFACTION SURVEYS AND INTERVIEWS AND DROPOUT SURVEYS WERE CONDUCTED. DESCRIPTIVE STATISTICS WERE USED TO ANALYZE SURVEY RESPONSES AND DEMOGRAPHIC INFORMATION. A PHENOMENOLOGICAL APPROACH WAS USED TO EXPLORE AND UNDERSTAND UNIQUE EXPERIENCES OF PARTICIPANT INTERVIEWS. DATA WERE ANALYZED USING NVIVO10. RESULTS: TWENTY-SIX WOMEN (M AGE 33.73 +/- 4.38) WERE COMPLETERS (> 3 WKS OF YOGA), 26 (M AGE 31.82 +/- 4.13) WERE NON-COMPLETERS (< 3 WKS OF YOGA), AND 22 (M AGE 32.94 +/- 2.93) DROPPED OUT. TWENTY COMPLETERS PARTICIPATED IN A POST-INTERVENTION SATISFACTION SURVEY WITH 75% (N=15) REPORTING BEING VERY SATISFIED OR SATISFIED WITH THE ONLINE YOGA INTERVENTION, FOUND IT TO BE VERY ENJOYABLE OR ENJOYABLE, AND VERY HELPFUL OR HELPFUL TO COPE WITH GRIEF. SATISFACTION AND PERCEPTIONS OF THE INTERVENTION IN THOSE WHO COMPLETED AN INTERVIEW (N=12) WERE CLUSTERED AROUND THE FOLLOWING THEMES: BENEFITS, BARRIERS, DISLIKES, SATISFACTION, AND PREFERENCES. OF THE 22 DROPOUTS, 14 COMPLETED A DROPOUT SURVEY. WOMEN WITHDREW FROM THE STUDY DUE TO PREGNANCY (N=3, 21%), BURDEN (N=3, 21%), STRESS (N=2, 14%), LACK OF TIME (N=2, 14%), DID NOT ENJOY (N=1, 7%), AND OTHER (N=3, 21%). CONCLUSION: FINDINGS HERE MAY BE USED TO HELP DESIGN FUTURE RESEARCH.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
4  273  52 ADDING A FACEBOOK SUPPORT GROUP TO AN ONLINE YOGA RANDOMIZED TRIAL FOR WOMEN WHO HAVE EXPERIENCED STILLBIRTH: A FEASIBILITY STUDY. OBJECTIVES: WOMEN WHO EXPERIENCE STILLBIRTH ARE MORE LIKELY TO DEVELOP POST-TRAUMATIC STRESS DISORDER (PTSD), AND ANXIOUS AND DEPRESSIVE SYMPTOMS THAN THOSE WHO DELIVER LIVE HEALTHY BABIES. PARTICIPANTS IN A RECENT STUDY OF ONLINE YOGA (OY) REPORTED A DESIRE FOR MORE SOCIAL SUPPORT, WHICH MAY HELP REDUCE PTSD RELATED TO GRIEF AND AID IN COPING. FACEBOOK (FB) HAS BEEN USED SUCCESSFULLY TO DELIVER SUPPORT FOR ONLINE INTERVENTIONS, BUT LITTLE IS KNOWN ABOUT ITS USE IN CONJUNCTION WITH OY. THE PURPOSE OF THIS STUDY WAS TO EXAMINE THE FEASIBILITY OF A FB SUPPORT GROUP IN CONJUNCTION WITH AN 8-WEEK OY INTERVENTION. DESIGN: RANDOMIZED PARALLEL FEASIBILITY TRIAL WITH A 1:1 STUDY GROUP ALLOCATION RATIO. SETTING/LOCATION: ONLINE. SUBJECTS: WOMEN (N = 60) WHO EXPERIENCED STILLBIRTH WITHIN THE PAST 3 YEARS. INTERVENTIONS: PARTICIPANTS WERE RECRUITED NATIONALLY TO PARTICIPATE AND RANDOMIZED INTO ONE OF TWO GROUPS: OY ONLY (N = 30) OR ONLINE YOGA WITH FACEBOOK (OYFB) (N = 30). BOTH GROUPS WERE ASKED TO COMPLETE 60 MIN OF OY PER WEEK. WOMEN IN THE OY GROUP WERE ASKED TO LOG ON TO A FB PAGE AT LEAST ONCE PER WEEK. OUTCOME MEASURES: ACCEPTABILITY (I.E., SATISFACTION) AND DEMAND (I.E., ATTENDANCE), PTSD, ANXIETY, DEPRESSIVE SYMPTOMS, SOCIAL SUPPORT. RESULTS: PARTICIPANTS WERE SATISFIED WITH AND ENJOYED OY, AND 8/13 FB ACCEPTABILITY BENCHMARKS WERE MET. THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN GROUPS IN MINUTES OF YOGA PER WEEK. CONCLUSIONS: THE ADDITION OF A FB GROUP TO AN OY INTERVENTION FOR WOMEN WHO HAVE EXPERIENCED STILLBIRTH IS FEASIBLE, ALTHOUGH MORE RESEARCH IS NEEDED TO INCREASE ITS EFFICACY. TRIAL REGISTRATION: NCT04077476. REGISTERED SEPTEMBER 4, 2019. RETROSPECTIVELY REGISTERED (HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT04077476).	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
5  945  43 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 </= .04). RELATIVE TO THE EF GROUP, YOGA PARTICIPANTS DEMONSTRATED SIGNIFICANTLY GREATER REDUCTIONS IN RLS SYMPTOMS AND SYMPTOM SEVERITY (P </= .01), AND GREATER IMPROVEMENTS IN PERCEIVED STRESS AND MOOD (P </= .04), AS WELL AS SLEEP QUALITY (P = .09); RLS SYMPTOMS DECREASED TO MINIMAL/MILD IN 77% OF YOGA GROUP PARTICIPANTS, WITH NONE SCORING IN THE SEVERE RANGE BY WEEK 12, VERSUS 24% AND 12%, RESPECTIVELY, IN EF PARTICIPANTS. IN THE YOGA GROUP, IRLS AND RLS SEVERITY SCORES DECLINED WITH INCREASING MINUTES OF HOMEWORK PRACTICE (R = .7, P = .009 AND R = .6, P = .03, RESPECTIVELY), SUGGESTING A POSSIBLE DOSE-RESPONSE RELATIONSHIP. CONCLUSIONS: FINDINGS OF THIS EXPLORATORY RCT SUGGEST THAT YOGA MAY BE EFFECTIVE IN REDUCING RLS SYMPTOMS AND SYMPTOM SEVERITY, DECREASING PERCEIVED STRESS, AND IMPROVING MOOD AND SLEEP IN ADULTS WITH RLS. CLINICAL TRIAL REGISTRATION: REGISTRY: CLINICALTRIALS.GOV; TITLE: YOGA VS. EDUCATION FOR RESTLESS LEGS: A FEASIBILITY STUDY; IDENTIFIER: NCT03570515; URL: HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT03570515.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
6  258  53 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	
                                                                                                                                                                                                                                                                                
7  518  39 COMPARING ONCE- VERSUS TWICE-WEEKLY YOGA CLASSES FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY LOW INCOME MINORITIES: A RANDOMIZED DOSING TRIAL. BACKGROUND. PREVIOUS STUDIES HAVE DEMONSTRATED THAT ONCE-WEEKLY YOGA CLASSES ARE EFFECTIVE FOR CHRONIC LOW BACK PAIN (CLBP) IN WHITE ADULTS WITH HIGH SOCIOECONOMIC STATUS. THE COMPARATIVE EFFECTIVENESS OF TWICE-WEEKLY CLASSES AND GENERALIZABILITY TO RACIALLY DIVERSE LOW INCOME POPULATIONS ARE UNKNOWN. METHODS. WE CONDUCTED A 12-WEEK RANDOMIZED, PARALLEL-GROUP, DOSING TRIAL FOR 95 ADULTS RECRUITED FROM AN URBAN SAFETY-NET HOSPITAL AND FIVE COMMUNITY HEALTH CENTERS COMPARING ONCE-WEEKLY (N = 49) VERSUS TWICE-WEEKLY (N = 46) STANDARDIZED YOGA CLASSES SUPPLEMENTED BY HOME PRACTICE. PRIMARY OUTCOMES WERE CHANGE FROM BASELINE TO 12 WEEKS IN PAIN (11-POINT SCALE) AND BACK-RELATED FUNCTION (23-POINT MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE). RESULTS. 82% OF PARTICIPANTS WERE NONWHITE; 77% HAD ANNUAL HOUSEHOLD INCOMES <$40,000. THE SAMPLE'S BASELINE MEAN PAIN INTENSITY [6.9 (SD 1.6)] AND FUNCTION [13.7 (SD 5.0)] REFLECTED MODERATE TO SEVERE BACK PAIN AND IMPAIRMENT. PAIN AND BACK-RELATED FUNCTION IMPROVED WITHIN BOTH GROUPS (P < 0.001). HOWEVER, THERE WERE NO DIFFERENCES BETWEEN ONCE-WEEKLY AND TWICE-WEEKLY GROUPS FOR PAIN REDUCTION [-2.1 (95% CI -2.9, -1.3) VERSUS -2.4 (95% CI -3.1, -1.8), P = 0.62] OR BACK-RELATED FUNCTION [-5.1 (95% CI -7.0, -3.2) VERSUS -4.9 (95% CI -6.5, -3.3), P = 0.83]. CONCLUSIONS. TWELVE WEEKS OF ONCE-WEEKLY OR TWICE-WEEKLY YOGA CLASSES WERE SIMILARLY EFFECTIVE FOR PREDOMINANTLY LOW INCOME MINORITY ADULTS WITH MODERATE TO SEVERE CHRONIC LOW BACK PAIN. THIS TRIAL IS REGISTERED WITH CLINICALTRIALS.GOV NCT01761617.	2013	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
8   74  36 A GROUP-BASED YOGA THERAPY INTERVENTION FOR URINARY INCONTINENCE IN WOMEN: A PILOT RANDOMIZED TRIAL. OBJECTIVE: THE AIM OF THIS STUDY IS TO EXAMINE THE FEASIBILITY, EFFICACY, AND SAFETY OF A GROUP-BASED YOGA THERAPY INTERVENTION FOR MIDDLE-AGED AND OLDER WOMEN WITH URINARY INCONTINENCE. METHODS: WE CONDUCTED A PILOT RANDOMIZED TRIAL OF AMBULATORY WOMEN AGED 40 YEARS AND OLDER WITH STRESS, URGENCY, OR MIXED-TYPE INCONTINENCE. WOMEN WERE RANDOMIZED TO A 6-WEEK YOGA THERAPY PROGRAM (N = 10) CONSISTING OF TWICE WEEKLY GROUP CLASSES AND ONCE WEEKLY HOME PRACTICE OR A WAIT-LIST CONTROL GROUP (N = 9). ALL PARTICIPANTS ALSO RECEIVED WRITTEN PAMPHLETS ABOUT STANDARD BEHAVIORAL SELF-MANAGEMENT STRATEGIES FOR INCONTINENCE. CHANGES IN INCONTINENCE WERE ASSESSED WITH 7-DAY VOIDING DIARIES. RESULTS: THE MEAN (SD) AGE WAS 61.4 (8.2) YEARS, AND THE MEAN BASELINE FREQUENCY OF INCONTINENCE WAS 2.5 (1.3) EPISODES/D. AFTER 6 WEEKS, THE TOTAL INCONTINENCE FREQUENCY DECREASED BY 70% (1.8 [0.9] FEWER EPISODES/D) IN THE YOGA THERAPY VERSUS 13% (0.3 [1.7] FEWER EPISODES/D) IN THE CONTROL GROUP (P = 0.049). PARTICIPANTS IN THE YOGA THERAPY GROUP ALSO REPORTED AN AVERAGE OF 71% DECREASE IN STRESS INCONTINENCE FREQUENCY (0.7 [0.8] FEWER EPISODES/D) COMPARED WITH A 25% INCREASE IN CONTROLS (0.2 [1.1] MORE EPISODES/D) (P = 0.039). NO SIGNIFICANT DIFFERENCES IN REDUCTION IN URGENCY INCONTINENCE WERE DETECTED BETWEEN THE YOGA THERAPY VERSUS CONTROL GROUPS (1.0 [1.0] VERSUS 0.5 [0.5] FEWER EPISODES/D; P = 0.20). ALL WOMEN STARTING THE YOGA THERAPY PROGRAM COMPLETED AT LEAST 90% OF THE GROUP CLASSES AND PRACTICE SESSIONS. TWO PARTICIPANTS IN EACH GROUP REPORTED ADVERSE EVENTS UNRELATED TO THE INTERVENTION. CONCLUSIONS: FINDINGS PROVIDE PRELIMINARY EVIDENCE TO SUPPORT THE FEASIBILITY, EFFICACY, AND SAFETY OF A GROUP-BASED YOGA THERAPY INTERVENTION TO IMPROVE URINARY INCONTINENCE IN WOMEN.	2014	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
9 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
10 2316  55 TRAUMA-SENSITIVE YOGA FOR POST-TRAUMATIC STRESS DISORDER IN WOMEN VETERANS WHO EXPERIENCED MILITARY SEXUAL TRAUMA: INTERIM RESULTS FROM A RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: TO CONDUCT AN INTERIM ANALYSIS OF DATA COLLECTED FROM AN ONGOING MULTISITE RANDOMIZED CLINICAL TRIAL (RCT) ASSESSING THE EFFECTIVENESS OF TRAUMA CENTER TRAUMA-SENSITIVE YOGA (TCTSY) FOR POST-TRAUMATIC STRESS DISORDER (PTSD) AMONG WOMEN VETERANS WITH PTSD RELATED TO MILITARY SEXUAL TRAUMA (MST). THE PURPOSE OF THE INTERIM ANALYSIS WAS TO ASSESS OUTCOMES FROM THE PRIMARY SITE, WHICH IS GEOGRAPHICALLY, DEMOGRAPHICALLY, CULTURALLY, AND PROCEDURALLY DISTINCT FROM THE SECOND SITE. DESIGN: RCT WAS CONDUCTED WITHIN A VETERANS ADMINISTRATION HEALTH CARE SYSTEM. DATA COLLECTION INCLUDED PREINTERVENTION THROUGH 3 MONTHS POSTINTERVENTION. PARTICIPANTS: ENROLLMENT FOR THE MAIN SITE WAS 152 WOMEN. THE SAMPLE SIZE FOR THE INTENT-TO-TREAT ANALYSIS WAS 104. THE MAJORITY WERE AFRICAN AMERICAN (91.3%) WITH A MEAN AGE OF 48.46 YEARS. INTERVENTION: THE TCTSY INTERVENTION (N = 58) WAS CONDUCTED BY TCTSY-CERTIFIED YOGA FACILITATORS AND CONSISTED OF 10 WEEKLY 60-MIN GROUP SESSIONS. THE CONTROL INTERVENTION, COGNITIVE PROCESSING THERAPY (CPT; N = 46), CONSISTED OF 12 90-MIN WEEKLY GROUP SESSIONS CONDUCTED PER VETERANS ADMINISTRATION PROTOCOL BY CLINICIANS IN THE PTSD CLINIC. OUTCOME MEASURES: THE CLINICIAN ADMINISTERED PTSD SCALE FOR DSM-5 (CAPS-5) WAS USED TO ASSESS CURRENT PTSD DIAGNOSIS AND SYMPTOM SEVERITY, INCLUDING OVERALL PTSD AND FOUR SYMPTOM CLUSTERS. THE PTSD CHECKLIST FOR DSM-5 (PCL-5) WAS USED TO OBTAIN SELF-REPORT OF PTSD SYMPTOM SEVERITY, INCLUDING TOTAL SCORE AND FOUR SYMPTOM CLUSTERS. RESULTS: THE FINDINGS REPORTED HERE ARE INTERIM RESULTS FROM ONE CLINICAL SITE. FOR BOTH THE CAPS-5 AND PCL-5, TOTAL SCORES AND ALL FOUR CRITERION SCORES DECREASED SIGNIFICANTLY (P < 0.01) OVER TIME IN ALL FIVE MULTILEVEL LINEAR MODELS WITHIN BOTH TCTSY AND CPT GROUPS, WITHOUT SIGNIFICANT DIFFERENCES BETWEEN GROUPS. THERE WERE CLINICALLY MEANINGFUL IMPROVEMENTS SEEN FOR BOTH TCTSY AND CPT WITH 51.1%-64.3% OF TCTSY SUBJECTS AND 43.5%-73.7% OF CPT DECREASING THEIR CAPS-5 SCORES BY 10 POINTS OR MORE. EFFECT SIZES FOR TOTAL SYMPTOM SEVERITY WERE LARGE FOR TCTSY (COHEN'S D = 1.10-1.18) AND CPT (COHEN'S D = 0.90-1.40). INTERVENTION COMPLETION WAS HIGHER IN TCTSY (60.3%) THAN IN CPT (34.8%). SYMPTOM IMPROVEMENT OCCURRED EARLIER FOR TCTSY (MIDINTERVENTION) THAN FOR CPT (2 WEEKS POSTINTERVENTION). SAFETY: THERE WERE NO UNANTICIPATED ADVERSE EVENTS IN THIS STUDY. CONCLUSION: THE RESULTS OF THIS STUDY DEMONSTRATE THAT TCTSY MAY BE AN EFFECTIVE TREATMENT FOR PTSD THAT YIELDS SYMPTOM IMPROVEMENT MORE QUICKLY, HAS HIGHER RETENTION THAN CPT, AND HAS A SUSTAINED EFFECT. TCTSY MAY BE AN EFFECTIVE ALTERNATIVE TO TRAUMA-FOCUSED THERAPY FOR WOMEN VETERANS WITH PTSD RELATED TO MST. THE STUDY IS REGISTERED IN CLINICALTRIALS.GOV (CTR NO.: NCT02640690).	2021	

11  312  38 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
12 1194  37 EXAMINING MEDIATORS AND MODERATORS OF YOGA FOR WOMEN WITH BREAST CANCER UNDERGOING RADIOTHERAPY. HYPOTHESIS THIS STUDY EXAMINES MODERATORS AND MEDIATORS OF A YOGA INTERVENTION TARGETING QUALITY-OF-LIFE (QOL) OUTCOMES IN WOMEN WITH BREAST CANCER RECEIVING RADIOTHERAPY.METHODS WOMEN UNDERGOING 6 WEEKS OF RADIOTHERAPY WERE RANDOMIZED TO A YOGA (YG; N = 53) OR STRETCHING (ST; N = 56) INTERVENTION OR A WAITLIST CONTROL GROUP (WL; N = 54). DEPRESSIVE SYMPTOMS AND SLEEP DISTURBANCES WERE MEASURED AT BASELINE. MEDIATOR (POSTTRAUMATIC STRESS SYMPTOMS, BENEFIT FINDING, AND CORTISOL SLOPE) AND OUTCOME (36-ITEM SHORT FORM [SF]-36 MENTAL AND PHYSICAL COMPONENT SCALES [MCS AND PCS]) VARIABLES WERE ASSESSED AT BASELINE, END-OF-TREATMENT, AND 1-, 3-, AND 6-MONTHS POSTTREATMENT. RESULTS BASELINE DEPRESSIVE SYMPTOMS (P = .03) AND SLEEP DISTURBANCES (P < .01) MODERATED THE GROUP X TIME EFFECT ON MCS, BUT NOT PCS. WOMEN WITH HIGH BASELINE DEPRESSIVE SYMPTOMS IN YG REPORTED MARGINALLY HIGHER 3-MONTH MCS THAN THEIR COUNTERPARTS IN WL (P = .11). WOMEN WITH HIGH BASELINE SLEEP DISTURBANCES IN YG REPORTED HIGHER 3-MONTHS MCS THAN THEIR COUNTERPARTS IN WL (P < .01) AND HIGHER 6-MONTH MCS THAN THEIR COUNTERPARTS IN ST (P = .01). YG LED TO GREATER BENEFIT FINDING THAN ST AND WL ACROSS THE FOLLOW-UP (P = .01). THREE-MONTH BENEFIT FINDING PARTIALLY MEDIATED THE EFFECT OF YG ON 6-MONTH PCS. POSTTRAUMATIC STRESS SYMPTOMS AND CORTISOL SLOPE DID NOT MEDIATE TREATMENT EFFECT ON QOL. CONCLUSION YOGA MAY PROVIDE THE GREATEST MENTAL-HEALTH-RELATED QOL BENEFITS FOR THOSE EXPERIENCING PRE-RADIOTHERAPY SLEEP DISTURBANCE AND DEPRESSIVE SYMPTOMS. YOGA MAY IMPROVE PHYSICAL-HEALTH-RELATED QOL BY INCREASING ABILITY TO FIND BENEFIT IN THE CANCER EXPERIENCE.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
13 1787  40 PREFERENCE AND EXPECTATION FOR TREATMENT ASSIGNMENT IN A RANDOMIZED CONTROLLED TRIAL OF ONCE- VS TWICE-WEEKLY YOGA FOR CHRONIC LOW BACK PAIN. BACKGROUND: IN STUDIES INVOLVING NONPHARMACOLOGICAL COMPLEMENTARY AND ALTERNATIVE MEDICINE INTERVENTIONS, PARTICIPANT BLINDING IS VERY DIFFICULT. PARTICIPANT EXPECTATIONS MAY AFFECT PERCEIVED BENEFIT OF THERAPY. IN STUDIES OF YOGA AS TREATMENT FOR CHRONIC LOW BACK PAIN, LITTLE IS KNOWN ABOUT THE RELATIONSHIP BETWEEN PATIENT EXPECTATIONS AND PREFERENCES ON OUTCOMES. THIS STUDY WAS DESIGNED TO IDENTIFY BASELINE PREDICTORS OF PREFERENCE AND TO DETERMINE IF EXPECTATIONS AND PREFERENCES FOR DIFFERENT DOSES OF YOGA AFFECT BACK-RELATED FUNCTION AND LOW BACK PAIN INTENSITY. METHODS: THIS WAS A SECONDARY DATA ANALYSIS OF A 12-WEEK RANDOMIZED CONTROLLED TRIAL COMPARING ONCE-WEEKLY VS TWICE-WEEKLY YOGA FOR TREATMENT OF CHRONIC LOW BACK PAIN IN 93 ADULTS FROM A PREDOMINANTLY LOW-INCOME MINORITY POPULATION. AT BASELINE, PARTICIPANTS WERE ASKED ABOUT BACK FUNCTION, BACK PAIN, TREATMENT EXPECTATIONS, AND TREATMENT PREFERENCES. WE CREATED A VARIABLE "CONCORDANCE" TO DESCRIBE THE MATCHING OF PARTICIPANT PREFERENCE TO RANDOMIZED TREATMENT. OUR OUTCOME VARIABLES WERE CHANGE IN BACK FUNCTION AND PAIN INTENSITY AFTER 12 WEEKS OF YOGA INSTRUCTION. WE PERFORMED LOGISTIC REGRESSION TO IDENTIFY PREDICTORS OF PREFERENCE FOR ONCE- OR TWICE-WEEKLY YOGA INSTRUCTION. WE CREATED LINEAR REGRESSION MODELS TO IDENTIFY INDEPENDENT ASSOCIATIONS BETWEEN EXPECTATIONS, PREFERENCE, CONCORDANCE, AND OUTCOMES. RESULTS: WORSE BACK FUNCTION AT BASELINE WAS ASSOCIATED WITH 20% HIGHER ODDS OF PREFERRING TWICE-WEEKLY YOGA (OR 1.2, CI 1.1, 1.3). INDIVIDUALS WITH HIGHER EXPECTATION SCORES FOR TWICE-WEEKLY YOGA HAD 90% HIGHER ODDS OF PREFERRING TWICE-WEEKLY VS ONCE-WEEKLY YOGA (OR 1.9, CI 1.3, 2.7). INDIVIDUALS WITH HIGHER EXPECTATION SCORES FOR ONCE-WEEKLY YOGA HAD 40% LESS ODDS OF PREFERRING TWICE-WEEKLY YOGA (OR 0.6, CI 0.5, 0.9). AFTER CONTROLLING FOR BASELINE CHARACTERISTICS, WE FOUND NO STATISTICALLY SIGNIFICANT RELATIONSHIP BETWEEN TREATMENT OUTCOMES, PREFERENCE, EXPECTATION SCORES, OR CONCORDANCE. CONCLUSION: IN A POPULATION OF PREDOMINANTLY LOW-INCOME MINORITY PARTICIPANTS WITH CHRONIC LOW BACK PAIN, WORSE BACK FUNCTION WAS ASSOCIATED WITH PREFERENCE FOR MORE FREQUENT YOGA CLASSES. THOSE WHO PREFERRED MORE YOGA CLASSES HAD HIGHER EXPECTATIONS FOR THOSE CLASSES. TWELVE-WEEK CHANGE IN BACK PAIN INTENSITY AND BACK FUNCTION WERE NOT AFFECTED BY DOSING PREFERENCE, EXPECTATION SCORE, OR CONCORDANCE. MORE RESEARCH IS NEEDED TO BETTER MEASURE AND QUANTIFY PREFERENCE, EXPECTATIONS, AND THEIR RELATIONSHIP TO OUTCOMES IN YOGA RESEARCH.	2015	
                                                                                                                                                                                                                                                                 
14 1748  38 PILOT RANDOMIZED, CONTROLLED TRIAL OF A DYADIC YOGA PROGRAM FOR GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR FAMILY CAREGIVERS. BACKGROUND: WHILE THE USE OF BEHAVIORAL MEDICINE IN MANAGING GLIOMA PATIENTS' SYMPTOMS IS NOT WELL STUDIED, THE HIGH SYMPTOM BURDEN IN PATIENTS AND THEIR FAMILY CAREGIVERS IS WELL ESTABLISHED. WE CONDUCTED A PILOT RANDOMIZED, CONTROLLED TRIAL TO EXAMINE THE FEASIBILITY AND PRELIMINARY EFFICACY OF A DYADIC YOGA (DY) INTERVENTION AS A SUPPORTIVE CARE STRATEGY. METHODS: GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR CAREGIVERS WERE RANDOMIZED TO A 12-SESSION DY OR WAITLIST CONTROL (WLC) GROUP. PRIOR TO RADIOTHERAPY AND RANDOMIZATION, BOTH GROUPS COMPLETED MEASURES OF CANCER-RELATED SYMPTOMS (MD ANDERSON SYMPTOM INVENTORY-BRAIN TUMOR MODULE), DEPRESSIVE SYMPTOMS (CENTER FOR EPIDEMIOLOGICAL STUDIES-DEPRESSION MEASURE), FATIGUE (BRIEF FATIGUE INVENTORY), AND OVERALL QUALITY OF LIFE (QOL; MEDICAL OUTCOMES STUDY 36-ITEM SHORT-FORM SURVEY). DYADS WERE REASSESSED AT THE LAST DAY OF RADIOTHERAPY. RESULTS: TWENTY PATIENTS (MEAN AGE: 46 YEARS, 50% FEMALE, 80% WHO GRADE IV AND CAREGIVERS (MEAN AGE: 50 YEARS, 70% FEMALE, 50% SPOUSES) PARTICIPATED IN THE TRIAL. A PRIORI FEASIBILITY CRITERIA WERE MET REGARDING CONSENT (70%), ADHERENCE (88%), AND RETENTION (95%) RATES. CONTROLLING FOR RELEVANT COVARIATES, CHANGE SCORE ANALYSES REVEALED CLINICALLY SIGNIFICANT IMPROVEMENTS FOR PATIENTS IN THE DY COMPARED WITH THE WLC GROUP FOR OVERALL CANCER SYMPTOM SEVERITY (D = 0.96) AND SYMPTOM INTERFERENCE (D = 0.74), DEPRESSIVE SYMPTOMS (D = 0.71), AND MENTAL QOL (D = 0.69). CAREGIVERS IN THE DY GROUP REPORTED CLINICALLY SIGNIFICANT IMPROVEMENTS IN DEPRESSIVE SYMPTOMS (D = 1.12), FATIGUE (D = 0.89), AND MENTAL QOL (D = 0.49) RELATIVE TO THOSE IN THE WLC GROUP. CONCLUSION: A DY INTERVENTION APPEARS TO BE A FEASIBLE AND BENEFICIAL SYMPTOM AND QOL MANAGEMENT STRATEGY FOR GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR CAREGIVERS. AN EFFICACY TRIAL WITH A MORE STRINGENT CONTROL GROUP IS WARRANTED. CLINICAL TRIAL NUMBER: NCT02481349.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
15 1682  47 ONLINE YOGA IN MYELOPROLIFERATIVE NEOPLASM PATIENTS: RESULTS OF A RANDOMIZED PILOT TRIAL TO INFORM FUTURE RESEARCH. BACKGROUND: MYELOPROLIFERATIVE NEOPLASM (MPN) PATIENTS SUFFER FROM SIGNIFICANT SYMPTOMS, INFLAMMATION AND REDUCED QUALITY OF LIFE. YOGA IMPROVES THESE OUTCOMES IN OTHER CANCERS, BUT THIS HASN'T BEEN DEMONSTRATED IN MPNS. THE PURPOSE OF THIS STUDY WAS TO: (1) EXPLORE THE LIMITED EFFICACY (DOES THE PROGRAM SHOW PROMISE OF SUCCESS) OF A 12-WEEK ONLINE YOGA INTERVENTION AMONG MPN PATIENTS ON SYMPTOM BURDEN AND QUALITY OF LIFE AND (2) DETERMINE FEASIBILITY (PRACTICALITY: TO WHAT EXTENT A MEASURE CAN BE CARRIED OUT) OF REMOTELY COLLECTING INFLAMMATORY BIOMARKERS. METHODS: PATIENTS WERE RECRUITED NATIONALLY AND RANDOMIZED TO ONLINE YOGA (60 MIN/WEEK OF YOGA) OR WAIT-LIST CONTROL (ASKED TO MAINTAIN NORMAL ACTIVITY). WEEKLY YOGA MINUTES WERE COLLECTED WITH CLICKY (ONLINE WEB ANALYTICS TOOL) AND SELF-REPORT. THOSE IN ONLINE YOGA COMPLETED A BLOOD DRAW AT BASELINE AND WEEK 12 TO ASSESS INFLAMMATION (INTERLEUKIN-6, TUMOR NECROSIS FACTOR-ALPHA [TNF-ALPHA]). ALL PARTICIPANTS COMPLETED QUESTIONNAIRES ASSESSING DEPRESSION, ANXIETY, FATIGUE, PAIN, SLEEP DISTURBANCE, SEXUAL FUNCTION, TOTAL SYMPTOM BURDEN, GLOBAL HEALTH, AND QUALITY OF LIFE AT BASELINE, WEEK SEVEN, 12, AND 16. CHANGE FROM BASELINE AT EACH TIME POINT WAS COMPUTED BY GROUP AND EFFECT SIZES WERE CALCULATED. PRE-POST INTERVENTION CHANGE IN INFLAMMATION FOR THE YOGA GROUP WAS COMPARED BY T-TEST. RESULTS: SIXTY-TWO MPN PATIENTS ENROLLED AND 48 COMPLETED THE INTERVENTION (ONLINE YOGA = 27; CONTROL GROUP = 21). YOGA PARTICIPATION AVERAGED 40.8 MIN/WEEK VIA CLICKY AND 56.1 MIN/WEEK VIA SELF-REPORT. SMALL/MODERATE EFFECT SIZES WERE GENERATED FROM THE YOGA INTERVENTION FOR SLEEP DISTURBANCE (D = - 0.26 TO - 0.61), PAIN INTENSITY (D = - 0.34 TO - 0.51), ANXIETY (D = - 0.27 TO - 0.37), AND DEPRESSION (D = - 0.53 TO - 0.78). A TOTAL OF 92.6 AND 70.4% OF ONLINE YOGA PARTICIPANTS COMPLETED THE BLOOD DRAW AT BASELINE AND WEEK 12, RESPECTIVELY, AND THERE WAS A DECREASE IN TNF-ALPHA FROM BASELINE TO WEEK 12 (- 1.3 +/- 1.5 PG/ML). CONCLUSIONS: ONLINE YOGA DEMONSTRATED SMALL EFFECTS ON SLEEP, PAIN, AND ANXIETY AS WELL AS A MODERATE EFFECT ON DEPRESSION. REMOTE BLOOD DRAW PROCEDURES ARE FEASIBLE AND THE EFFECT SIZE OF THE INTERVENTION ON TNF-ALPHA WAS LARGE. FUTURE FULLY POWERED RANDOMIZED CONTROLLED TRIALS ARE NEEDED TO TEST FOR EFFICACY. TRIAL REGISTRATION: THIS TRIAL WAS RETROSPECTIVELY REGISTERED WITH CLINICALTRIALS.GOV (ID: NCT03503838 ) ON 4/19/2018.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                   
16 2604  50 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
17 1118  42 EFFICACY OF AN EIGHT-WEEK YOGA INTERVENTION ON SYMPTOMS OF RESTLESS LEGS SYNDROME (RLS): A PILOT STUDY. BACKGROUND: RESTLESS LEGS SYNDROME (RLS) IS A COMMON AND HIGHLY BURDENSOME SLEEP DISORDER. WHILE RELAXATION THERAPIES, INCLUDING YOGA, ARE OFTEN RECOMMENDED FOR RLS MANAGEMENT, RIGOROUS SUPPORTING RESEARCH IS SPARSE. THE GOAL OF THIS PRELIMINARY STUDY WAS TO ASSESS THE EFFECTS OF YOGA ON RLS SYMPTOMS AND RELATED OUTCOMES IN WOMEN WITH RLS. METHODS: PARTICIPANTS WERE 13 NONSMOKING WOMEN WITH MODERATE TO SEVERE RLS, WHO DID NOT HAVE DIABETES, SLEEP APNEA, OR OTHER SERIOUS CONCOMITANT CHRONIC CONDITIONS, AND WHO WERE NOT PREGNANT. THE INTERVENTION WAS A GENTLE, 8-WEEK IYENGAR YOGA PROGRAM. CORE OUTCOMES ASSESSED PRE- AND POST-TREATMENT WERE RLS SYMPTOMS AND SYMPTOM SEVERITY (INTERNATIONAL RLS SCALE [IRLS] AND RLS ORDINAL SCALE), SLEEP QUALITY (MEDICAL OUTCOMES STUDY SLEEP SCALE), MOOD (PROFILE OF MOOD STATES), AND PERCEIVED STRESS (PERCEIVED STRESS SCALE). PARTICIPANTS ALSO COMPLETED YOGA LOGS AND A BRIEF EXIT QUESTIONNAIRE REGARDING THEIR EXPERIENCE WITH THE STUDY. RESULTS: TEN (10) WOMEN, AGED 32-66 YEARS, COMPLETED THE STUDY. PARTICIPANTS ATTENDED AN AVERAGE 13.4+/-0.5 (OF 16 POSSIBLE) CLASSES, AND COMPLETED A MEAN OF 4.1+/-0.3 (OF 5 POSSIBLE) HOMEWORK SESSIONS/WEEK. AT FOLLOW-UP, PARTICIPANTS DEMONSTRATED STRIKING REDUCTIONS IN RLS SYMPTOMS AND SYMPTOM SEVERITY, WITH SYMPTOMS DECREASING TO MINIMAL/MILD IN ALL BUT 1 WOMAN AND NO PARTICIPANT SCORING IN THE SEVERE RANGE BY WEEK 8. EFFECT SIZES (COHEN'S D) WERE LARGE: 1.6 FOR IRLS TOTAL, AND 2.2 FOR RLS ORDINAL SCALE. IRLS SCORES DECLINED SIGNIFICANTLY WITH INCREASING MINUTES OF HOMEWORK PRACTICE PER SESSION (R=0.70, P=0.025) AND TOTAL HOMEWORK MINUTES (R=0.64, P<0.05), SUGGESTING A POSSIBLE DOSE-RESPONSE RELATION. PARTICIPANTS ALSO SHOWED SIGNIFICANT IMPROVEMENTS IN SLEEP, PERCEIVED STRESS, AND MOOD (ALL P'S</=0.02), WITH EFFECT SIZES RANGING FROM 1.0 TO 1.6. CONCLUSIONS: THESE PRELIMINARY FINDINGS SUGGEST THAT YOGA MAY BE EFFECTIVE IN ATTENUATING RLS SYMPTOMS AND SYMPTOM SEVERITY, REDUCING PERCEIVED STRESS, AND IMPROVING SLEEP AND MOOD IN WOMEN WITH RLS.	2013	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
18 2132  31 THE EFFECTS OF A GENTLE YOGA PROGRAM ON SLEEP, MOOD, AND BLOOD PRESSURE IN OLDER WOMEN WITH RESTLESS LEGS SYNDROME (RLS): A PRELIMINARY RANDOMIZED CONTROLLED TRIAL. OBJECTIVE. TO EXAMINE THE EFFECTS OF YOGA VERSUS AN EDUCATIONAL FILM PROGRAM ON SLEEP, MOOD, PERCEIVED STRESS, AND SYMPATHETIC ACTIVATION IN OLDER WOMEN WITH RLS. METHODS. PARTICIPANTS WERE DRAWN FROM A LARGER TRIAL REGARDING THE EFFECTS OF YOGA ON CARDIOVASCULAR DISEASE RISK PROFILES IN OVERWEIGHT, SEDENTARY POSTMENOPAUSAL WOMEN. SEVENTY-FIVE WOMEN WERE RANDOMIZED TO RECEIVE EITHER AN 8-WEEK YOGA (N = 38) OR EDUCATIONAL FILM (N = 37) PROGRAM. ALL 75 PARTICIPANTS COMPLETED AN RLS SCREENING QUESTIONNAIRE. THE 20 WOMEN WHO MET ALL FOUR DIAGNOSTIC CRITERIA FOR RLS (N = 10 YOGA, 10 FILM GROUP) COMPRISED THE POPULATION FOR THIS NESTED STUDY. MAIN OUTCOMES ASSESSED PRE- AND POST-TREATMENT INCLUDED: SLEEP (PITTSBURGH SLEEP QUALITY INDEX), STRESS (PERCEIVED STRESS SCALE), MOOD (PROFILE OF MOOD STATES, STATE-TRAIT ANXIETY INVENTORY), BLOOD PRESSURE, AND HEART RATE. RESULTS. THE YOGA GROUP DEMONSTRATED SIGNIFICANTLY GREATER IMPROVEMENTS THAN CONTROLS IN MULTIPLE DOMAINS OF SLEEP QUALITY AND MOOD, AND SIGNIFICANTLY GREATER REDUCTIONS IN INSOMNIA PREVALENCE, ANXIETY, PERCEIVED STRESS, AND BLOOD PRESSURE (ALL P'S</=0.05). ADJUSTED INTERGROUP EFFECT SIZES FOR PSYCHOSOCIAL VARIABLES WERE LARGE, RANGING FROM 1.9 FOR STATE ANXIETY TO 2.6 FOR SLEEP QUALITY. CONCLUSIONS. THESE PRELIMINARY FINDINGS SUGGEST YOGA MAY OFFER AN EFFECTIVE INTERVENTION FOR IMPROVING SLEEP, MOOD, PERCEIVED STRESS, AND BLOOD PRESSURE IN OLDER WOMEN WITH RLS.	2012	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
19 2325  39 TREATMENT OF MAJOR DEPRESSIVE DISORDER WITH IYENGAR YOGA AND COHERENT BREATHING: A RANDOMIZED CONTROLLED DOSING STUDY. OBJECTIVES: THE AIMS OF THIS STUDY WERE TO ASSESS THE EFFECTS OF AN INTERVENTION OF IYENGAR YOGA AND COHERENT BREATHING AT FIVE BREATHS PER MINUTE ON DEPRESSIVE SYMPTOMS AND TO DETERMINE OPTIMAL INTERVENTION YOGA DOSING FOR FUTURE STUDIES IN INDIVIDUALS WITH MAJOR DEPRESSIVE DISORDER (MDD). METHODS: SUBJECTS WERE RANDOMIZED TO THE HIGH-DOSE GROUP (HDG) OR LOW-DOSE GROUP (LDG) FOR A 12-WEEK INTERVENTION OF THREE OR TWO INTERVENTION CLASSES PER WEEK, RESPECTIVELY. ELIGIBLE SUBJECTS WERE 18-64 YEARS OLD WITH MDD, HAD BASELINE BECK DEPRESSION INVENTORY-II (BDI-II) SCORES >/=14, AND WERE EITHER ON NO ANTIDEPRESSANT MEDICATIONS OR ON A STABLE DOSE OF ANTIDEPRESSANTS FOR >/=3 MONTHS. THE INTERVENTION INCLUDED 90-MIN CLASSES PLUS HOMEWORK. OUTCOME MEASURES WERE BDI-II SCORES AND INTERVENTION COMPLIANCE. RESULTS: FIFTEEN HDG (MAGE = 38.4 +/- 15.1 YEARS) AND 15 LDG (MAGE = 34.7 +/- 10.4 YEARS) SUBJECTS COMPLETED THE INTERVENTION. BDI-II SCORES AT SCREENING AND COMPLIANCE DID NOT DIFFER BETWEEN GROUPS (P = 0.26). BDI-II SCORES DECLINED SIGNIFICANTLY FROM SCREENING (24.6 +/- 1.7) TO WEEK 12 (6.0 +/- 3.8) FOR THE HDG (-18.6 +/- 6.6; P < 0.001), AND FROM SCREENING (27.7 +/- 2.1) TO WEEK 12 (10.1 +/- 7.9) IN THE LDG (-17.7 +/- 9.3; P < 0.001). THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN GROUPS, BASED ON RESPONSE (I.E., >50% DECREASE IN BDI-II SCORES; P = 0.65) FOR THE HDG (13/15 SUBJECTS) AND LDG (11/15 SUBJECTS) OR REMISSION (I.E., NUMBER OF SUBJECTS WITH BDI-II SCORES <14; P = 1.00) FOR THE HDG (14/15 SUBJECTS) AND LDG (13/15 SUBJECTS) AFTER THE 12-WEEK INTERVENTION, ALTHOUGH A GREATER NUMBER OF SUBJECTS IN THE HDG HAD 12-WEEK BDI-II SCORES </=10 (P = 0.04). CONCLUSION: DURING THIS 12-WEEK INTERVENTION OF YOGA PLUS COHERENT BREATHING, DEPRESSIVE SYMPTOMS DECLINED SIGNIFICANTLY IN PATIENTS WITH MDD IN BOTH THE HDG AND LDG. BOTH GROUPS SHOWED COMPARABLE COMPLIANCE AND CLINICAL IMPROVEMENTS, WITH MORE SUBJECTS IN THE HDG EXHIBITING BDI-II SCORES </=10 AT WEEK 12.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
20 1724  46 PERCEPTIONS OF MYELOPROLIFERATIVE NEOPLASM PATIENTS PARTICIPATING IN AN ONLINE YOGA INTERVENTION: A QUALITATIVE STUDY. MYELOPROLIFERATIVE NEOPLASMS (MPNS) ARE RARE HEMATOLOGICAL MALIGNANCIES WITH A SIGNIFICANT SYMPTOM BURDEN OFTEN LEFT UNRESOLVED DESPITE RECENT ADVANCES IN PHARMACOLOGICAL THERAPY. YOGA IS A NONPHARMACOLOGICAL STRATEGY THAT HAS BEEN SHOWN TO IMPROVE SYMPTOMS IN OTHER CANCERS AND MAY BE EFFECTIVE FOR IMPROVING SYMPTOMS IN MPN PATIENTS. ONLINE YOGA HELPS ADDRESS MANY OF THE COMMONLY REPORTED BARRIERS OF CANCER PATIENTS TO IN-PERSON INTERVENTIONS AND MAY MAKE YOGA MORE ACCESSIBLE TO MPNS. AN EXPLORATION OF MPN PATIENT PERCEPTIONS OF PARTICIPATION IN ONLINE YOGA IS NEEDED TO TAILOR INTERVENTIONS TO PATIENT NEEDS AND INFORM FUTURE STUDIES. THE PURPOSE OF THIS STUDY WAS TO EXPLORE THE PERCEPTIONS OF MPN PATIENTS PARTICIPATING IN A 12-WEEK ONLINE YOGA INTERVENTION. THIS ARTICLE REPRESENTS THE COMBINED QUALITATIVE INTERVIEW DATA FROM TWO STUDIES. PARTICIPANTS WERE ASKED TO COMPLETE 60 MIN/WK OF ONLINE, HOME-BASED YOGA AND WERE ASKED TO PARTICIPATE IN A 15- TO 20-MINUTE PHONE INTERVIEW POSTINTERVENTION. THE QUALITATIVE DATA WAS CODED IN NVIVO 11 FOR CONTENT ANALYSIS. THE TOTAL SAMPLE INCLUDED 39 MPN PATIENTS. ONLINE YOGA WAS WELL ACCEPTED AND LIKED AMONG THESE PATIENTS. THEY REPORTED PHYSICAL (EG, IMPROVED SLEEP, REDUCED FATIGUE) AND MENTAL (EG, REDUCED STRESS) HEALTH BENEFITS AND LIKED THE CONVENIENCE OF BEING ABLE TO DO YOGA AT HOME. ONLINE YOGA PROVIDES A FEASIBLE AND ATTRACTIVE FORMAT THROUGH WHICH TO DELIVER A NONPHARMACOLOGICAL INTERVENTION AMONG MPN PATIENTS. RANDOMIZED CONTROLLED TRIALS ARE NEEDED TO CONFIRM THE EFFECTS OF ONLINE YOGA ON MPN PATIENT SYMPTOMS. THE QUALITATIVE FINDINGS PRESENTED HERE HELP INFORM THE DEVELOPMENT OF THESE FUTURE TRIALS.	2018