1  109 134 A PILOT STUDY ASSESSING ACCEPTABILITY AND FEASIBILITY OF HATHA YOGA FOR CHRONIC PAIN IN PEOPLE RECEIVING OPIOID AGONIST THERAPY FOR OPIOID USE DISORDER. THE PURPOSE OF THIS PROJECT WAS TO ASSESS THE FEASIBILITY AND ACCEPTABILITY OF A HATHA YOGA PROGRAM DESIGNED TO TARGET CHRONIC PAIN IN PEOPLE RECEIVING OPIOID AGONIST THERAPY FOR OPIOID USE DISORDER. WE CONDUCTED A PILOT RANDOMIZED TRIAL IN WHICH PEOPLE WITH CHRONIC PAIN WHO WERE RECEIVING EITHER METHADONE MAINTENANCE THERAPY (N=20) OR BUPRENORPHINE (N=20) WERE RANDOMLY ASSIGNED TO WEEKLY HATHA YOGA OR HEALTH EDUCATION (HE) CLASSES FOR 3MONTHS. WE DEMONSTRATED FEASIBILITY IN MANY DOMAINS, INCLUDING RECRUITMENT OF PARTICIPANTS (58% FEMALE, MEAN AGE 43), RETENTION FOR FOLLOW-UP ASSESSMENTS, AND ABILITY OF TEACHERS TO PROVIDE INTERVENTIONS WITH HIGH FIDELITY TO THE MANUALS. FIFTY PERCENT OF PARTICIPANTS IN YOGA (95% CI: 0.28-0.72) AND 65% OF PARTICIPANTS IN HE (95% CI: 0.44-0.87) ATTENDED AT LEAST 6 OF 12 POSSIBLE CLASSES (P=0.62). SIXTY-ONE PERCENT IN THE YOGA GROUP REPORTED PRACTICING YOGA AT HOME, WITH A MEAN NUMBER OF TIMES PRACTICING PER WEEK OF 2.67 (SD=2.37). PARTICIPANT MOOD IMPROVED PRE-CLASS TO POST-CLASS, WITH GREATER DECREASES IN ANXIETY AND PAIN FOR THOSE IN THE YOGA GROUP (P<0.05). IN CONCLUSION, YOGA CAN BE DELIVERED ON-SITE AT OPIOID AGONIST TREATMENT PROGRAMS WITH HOME PRACTICE TAKEN UP BY THE MAJORITY OF PARTICIPANTS. FUTURE RESEARCH MAY EXPLORE WAYS OF INCREASING THE YOGA "DOSAGE" RECEIVED. THIS MAY INVOLVE TESTING STRATEGIES FOR INCREASING EITHER CLASS ATTENDANCE OR THE AMOUNT OF HOME PRACTICE OR BOTH.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
2  622  45 DEVELOPMENT, VALIDATION, AND FEASIBILITY TESTING OF A YOGA MODULE FOR OPIOID USE DISORDER. CONTEXT: OPIOID USE DISORDER (OUD) INVOLVES EXCESSIVE USE OF OPIOIDS-SUCH AS HEROIN, MORPHINE, FENTANYL, CODEINE, OXYCODONE, AND HYDROCODONE-LEADING TO MAJOR HEALTH, SOCIAL, AND ECONOMIC CONSEQUENCES. YOGA LIFESTYLE INTERVENTIONS HAVE BEEN FOUND TO BE USEFUL AS ADJUNCT THERAPIES IN MANAGEMENT OF SUBSTANCE USE DISORDERS AND CHRONIC PAIN CONDITIONS. OBJECTIVE: THE RESEARCH TEAM INTENDED TO DEVELOP, VALIDATE, AND TEST FOR FEASIBILITY A YOGA PROGRAM FOR OUD PATIENTS THAT COULD REDUCE OPIATE WITHDRAWAL SYMPTOMS-SUCH AS PAIN, FATIGUE, LOW MOOD, ANXIETY AND SLEEP DISTURBANCES-AND CRAVINGS ASSOCIATED WITH DRUGS. DESIGN: THE RESEARCH TEAM FIRST PERFORMED A LITERATURE REVIEW OF TRADITIONAL AND CONTEMPORARY YOGA TEXTS, SUCH AS HATHA YOGA PRADIPIKA AND LIGHT ON YOGA, AS WELL AS MODERN SCIENTIFIC LITERATURE IN THE FOLLOWING SEARCH ENGINES-GOOGLE SCHOLAR, PUBMED, AND PSYCHINFO, USING THE KEYWORDS YOGA, PRANAYAMA, HATHA YOGA, RELAXATION. MEDITATION, SUBSTANCE USE, ADDICTION, IMPULSIVITY, CRAVING, SLEEP QUALITY, AND FATIGUE. USING THE INFORMATION OBTAINED, THE TEAM DEVELOPED A YOGA PROGRAM AND DESIGNED A PILOT STUDY THAT USED THE PROGRAM. SETTING: THE STUDY TOOK PLACE IN THE DEPARTMENT OF INTEGRATIVE MEDICINE AT THE NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES (NIMHANS) IN BANGALORE, INDIA. PARTICIPANTS: PARTICIPANTS IN THE PILOT STUDY WERE 8 INPATIENTS, 6 MALES AND 2 FEMALES, WHO WERE ON OPIOID AGONIST TREATMENT (BUPRENORPHINE) FOR OUD. INTERVENTION: THE INTERVENTION WAS THE YOGA PROGRAM PREVIOUSLY VALIDATED BY THE RESEARCH TEAM. IN THE PILOT STUDY, PARTICIPANTS WERE TAUGHT A ONE-HOUR, YOGA-BASED INTERVENTION, WITH SESSIONS OCCURRING ONCE PER DAY, FOR 10 SESSIONS. OUTCOME MEASURES: FOR VALIDATION, 13 EXPERTS SCORED THE YOGA PROGRAM THAT THE RESEARCH TEAM HAD DEVELOPED AND GAVE SUGGESTIONS FOR EACH YOGIC PRACTICE FOR USE DURING THE ACUTE PHASE OF WITHDRAWAL AND THE MAINTENANCE PHASE RESPECTIVELY. A CONTENT VALIDITY RATIO (CVR) WAS CALCULATED FROM THEIR SCORING, AND THE RESEARCH TEAM MADE CHANGES TO THE PROGRAM BASE ON THE SCORING AND SUGGESTIONS. FOR THE PILOT STUDY, ASSESSMENTS OCCURRED AT BASELINE AND POSTINTERVENTION. THE PARTICIPANTS' YOGA PERFORMANCE WAS RATED BY THE YOGA TRAINER ON A YOGA PERFORMANCE ASSESSMENT SCALE (YPA). OTHER MEASUREMENTS INCLUDED: (1) THE CLINICAL OPIATE WITHDRAWAL SCALE (COWS), (2) THE HAMILTON'S ANXIETY RATING SCALE (HAM-A), (3) THE HAMILTON'S DEPRESSION RATING SCALE (HAM-D), (4) BUPRENORPHINE DOSAGE, (5) THE CLINICAL GLOBAL IMPRESSION SEVERITY (CGI-S) SCALE, (6) A VISUAL ANALOG SCALE (VAS) FOR PAIN, (7) SLEEP QUALITY (LATENCY AND DURATION), AND (8) THE MODULE'S SAFETY. RESULTS: FOUR PRACTICES WERE REMOVED FROM THE PROGRAM DUE TO CVR SCORES BELOW THE CUTOFF, AND ONE PRACTICE WAS FOUND NOT TO BE FEASIBLE (KAPALABHATI). TWO CATEGORIES OF YOGA MODULES EMERGED: (1) FOR THE ACUTE SYMPTOMATIC PHASE (40 MINUTES) AND (2) FOR THE MAINTENANCE PHASE (ONE HOUR). PRACTICES WERE ADDED OR EXCLUDED BASED ON THE PHASE. CONCLUSIONS: THE YOGA MODULE THAT WAS DEVELOPED FOR REDUCING WITHDRAWAL SYMPTOMS AND CRAVINGS IN OUD PATIENTS WAS FOUND TO BE SAFE, FEASIBLE, AND POTENTIALLY USEFUL AS AN ADJUNCT THERAPY TO CONVENTIONAL TREATMENT.	2021	

3  517  41 COMPARING HATHA YOGA WITH DYNAMIC GROUP PSYCHOTHERAPY FOR ENHANCING METHADONE MAINTENANCE TREATMENT: A RANDOMIZED CLINICAL TRIAL. BACKGROUND: AS MORE METHADONE TREATMENT PROGRAMS ARE FUNDED IN AN ATTEMPT TO CURB SUBSTANCE ABUSE AND HIV INFECTION AMONG I.V. DRUG USERS, MORE COST EFFECTIVE TREATMENT APPROACHES ARE BEING SOUGHT. OBJECTIVES: TO INVESTIGATE WHETHER CLIENTS IN OUTPATIENT METHADONE MAINTENANCE TREATMENT WHO PRACTICE WEEKLY HATHA YOGA IN A GROUP SETTING EXPERIENCE MORE FAVORABLE TREATMENT OUTCOMES THAN THOSE WHO RECEIVE CONVENTIONAL GROUP PSYCHODYNAMIC THERAPY. METHODS: AFTER A 5-DAY ASSESSMENT PERIOD, 61 PATIENTS WERE RANDOMLY ASSIGNED TO METHADONE MAINTENANCE ENHANCED BY TRADITIONAL GROUP PSYCHOTHERAPY (IE, CONVENTIONAL METHADONE TREATMENT) OR AN ALTERNATIVE HATHA YOGA THERAPY (IE, ALTERNATIVE METHADONE TREATMENT). PATIENTS WERE FOLLOWED FOR 6 MONTHS AND EVALUATED ON A VARIETY OF PSYCHOLOGICAL, SOCIOLOGICAL, AND BIOLOGICAL MEASURES. THE REVISED SYMPTOM CHECK LIST PROVIDED THE PRIMARY PSYCHOLOGICAL MEASURES; THE ADDICTION SEVERITY INDEX PROVIDED VARIOUS INDICES OF ADDICTIVE BEHAVIORS. RESULTS: THE EVIDENCE REVEALED THAT THERE WERE NO MEANINGFUL DIFFERENCES BETWEEN TRADITIONAL PSYCHODYNAMIC GROUP THERAPY AND HATHA YOGA PRESENTED IN A GROUP SETTING. BOTH TREATMENTS CONTRIBUTED TO A TREATMENT REGIMEN THAT SIGNIFICANTLY REDUCED DRUG USE AND CRIMINAL ACTIVITIES. PSYCHOPATHOLOGY AT ADMISSION WAS SIGNIFICANTLY RELATED TO PROGRAM PARTICIPATION REGARDLESS OF TREATMENT GROUP. DISCUSSION: IN ADDITION TO EXAMINING THE CHARACTERISTICS OF PATIENTS WHO PRESENT FOR TREATMENT, THIS STUDY IDENTIFIES UNEXPECTED STAFF ISSUES THAT COMPLICATE THE INTEGRATION OF ALTERNATIVE AND TRADITIONAL TREATMENT STRATEGIES. CONCLUSION: ALTERNATIVE METHADONE TREATMENT IS NOT MORE EFFECTIVE THAN CONVENTIONAL METHADONE TREATMENT, AS ORIGINALLY HYPOTHESIZED. HOWEVER, SOME PATIENTS MAY BENEFIT MORE FROM ALTERNATIVE METHADONE TREATMENT THAN CONVENTIONAL METHADONE TREATMENT. ADDITIONAL RESEARCH IS NECESSARY TO DETERMINE CHARACTERISTICS THAT IDENTIFY PATIENTS WHO MIGHT BENEFIT FROM ALTERNATIVE METHADONE TREATMENT.	1997	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
4  258  42 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
5  172  32 A RANDOMIZED CONTROLLED PILOT STUDY OF YOGA SKILLS TRAINING VERSUS AN ATTENTION CONTROL DELIVERED DURING CHEMOTHERAPY ADMINISTRATION. CONTEXT: IT IS IMPORTANT TO ADDRESS FATIGUE AND CO-OCCURRING SYMPTOMS DURING CHEMOTHERAPY TO PRESERVE QUALITY OF LIFE IN PATIENTS WITH GASTROINTESTINAL (GI) CANCER. OBJECTIVE: TO CONDUCT A RANDOMIZED CONTROLLED PILOT STUDY OF A YOGA SKILLS TRAINING (YST) INTERVENTION COMPARED TO AN ATTENTION CONTROL (AC) AMONG ADULTS DIAGNOSED WITH GI CANCER. METHODS: YST CONSISTED OF FOUR 30-MINUTE SESSIONS DELIVERED INDIVIDUALLY DURING CHEMOTHERAPY PLUS HOME PRACTICE. AC PROVIDED EMPATHIC ATTENTION PLUS HOME DIARIES. PATIENT-REPORTED (PROMIS T-SCORE) ASSESSMENTS OF FATIGUE, DEPRESSIVE SYMPTOMS, SLEEP DISTURBANCES, AND PSYCHOLOGICAL STRESS (PERCEIVED STRESS SCALE) WERE COLLECTED AT CHEMOTHERAPY VISITS: BASELINE, WEEK 8, WEEK 10 AND WEEK 14, AND ANALYZED USING A MIXED EFFECTS MODEL. INFLAMMATORY CYTOKINES WERE ASSESSED AT BASELINE AND WEEK 10. RESULTS: FORTY-FOUR OF 77 ADULTS APPROACHED AGREED TO PARTICIPATE (57%; YST N = 23; AC N = 21). PARTICIPANTS' MEAN AGE WAS 58 YEARS AND 48% WERE MEN. PARTICIPANTS RANDOMIZED TO YST REPORTED A LARGER DECLINE IN FATIGUE (-2.4 DIFFERENCE, D = 0.30) AND DEPRESSIVE SYMPTOMS (-2.5 DIFFERENCE, D = 0.30) THAN AC PARTICIPANTS FROM BASELINE TO WEEK 10 AND SLEEP DISTURBANCES AT WEEK 8 (-3.9 DIFFERENCE, D = 0.50). DIFFERENCES IN MAGNITUDE OF CHANGE IN SYMPTOMS WERE CONSISTENT WITH OR EXCEEDED A MINIMALLY IMPORTANT DIFFERENCE. PSYCHOLOGICAL STRESS DECREASED MORE IN THE AC AT WEEK 10 (D = 0.30). REDUCTIONS IN INFLAMMATORY CYTOKINES (IL-6, STNF R1) WERE LARGER IN THE YST GROUP THAN AC. CONCLUSION: YST SHOWED PROMISE FOR IMPROVING FATIGUE, DEPRESSIVE SYMPTOMS, SLEEP DISTURBANCES, AND INFLAMMATION. YST IS ALSO FEASIBLE AND REACHES PATIENTS UNDERREPRESENTED IN YOGA RESEARCH (I.E., GI CANCER, MEN), THUS WARRANTING FURTHER EXAMINATION.	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
6 1224  35 FEASIBILITY AND ASSESSMENT OF OUTCOME MEASURES FOR YOGA AS SELF-CARE FOR MINORITIES WITH ARTHRITIS: A PILOT STUDY. BACKGROUND: WHILE THERE IS A GROWING INTEREST IN THE THERAPEUTIC BENEFITS OF YOGA, MINORITY POPULATIONS WITH ARTHRITIS TEND TO BE UNDER-REPRESENTED IN THE RESEARCH. ADDITIONALLY, THERE IS AN ABSENCE OF GUIDANCE IN THE LITERATURE REGARDING THE USE OF MULTICULTURAL TEAMS AND SOCIOCULTURAL HEALTH BELIEFS, WHEN DESIGNING YOGA STUDIES FOR A RACIALLY DIVERSE POPULATION WITH ARTHRITIS. THIS PILOT STUDY EXAMINED THE FEASIBILITY OF OFFERING YOGA AS A SELF-CARE MODALITY TO AN URBAN, BILINGUAL, MINORITY POPULATION WITH OSTEOARTHRITIS (OA) OR RHEUMATOID ARTHRITIS (RA), IN THE WASHINGTON, DC AREA. METHODS: THE PRIMARY OBJECTIVE OF THE STUDY WAS TO ASSESS THE FEASIBILITY OF OFFERING AN 8-WEEK, BILINGUAL YOGA INTERVENTION ADAPTED FOR ARTHRITIS TO A CONVENIENCE SAMPLE OF PRIMARILY HISPANIC AND BLACK/AFRICAN-AMERICAN ADULTS. A RACIALLY DIVERSE INTERDISCIPLINARY RESEARCH TEAM WAS ASSEMBLED TO DESIGN A STUDY TO FACILITATE RECRUITMENT AND RETENTION. THE SECOND OBJECTIVE IDENTIFIED OUTCOME MEASURES TO OPERATIONALIZE POTENTIAL FACILITATORS AND BARRIERS TO SELF-CARE AND SELF-EFFICACY. THE THIRD OBJECTIVE DETERMINED THE FEASIBILITY OF USING COMPUTER-ASSISTED SELF-INTERVIEW (CASI) FOR DATA COLLECTION. RESULTS: ENROLLED PARTICIPANTS (N = 30) WERE MOSTLY FEMALE (93%), SPANISH SPEAKING (69%), AND DIAGNOSED WITH RA (88.5%). FEASIBILITY WAS EVALUATED USING PRACTICALITY, ACCEPTABILITY, ADAPTATION, AND EXPANSION OF AN ARTHRITIS-ADAPTED YOGA INTERVENTION, MODIFIED FOR THIS POPULATION. RECRUITMENT (51%) AND PARTICIPATION (60%) RATES WERE SIMILAR TO PREVIOUS RESEARCH AND CLINICAL EXPERIENCE WITH THE STUDY POPULATION. OF THOSE ENROLLED, 18 STARTED THE INTERVENTION. FOR ADHERENCE, 12 OUT OF 18 (67%) PARTICIPANTS COMPLETED THE INTERVENTION. ALL (100%), WHO COMPLETED THE INTERVENTION, CONTINUED TO PRACTICE YOGA 3 MONTHS AFTER COMPLETING THE STUDY. USING NONPARAMETRIC TESTS, SELECTED OUTCOME MEASURES SHOWED A MEASURABLE CHANGE POST-INTERVENTION SUGGESTING APPROPRIATE USE IN FUTURE STUDIES. AN IN-PERSON COMPUTERIZED QUESTIONNAIRE WAS DETERMINED TO BE A FEASIBLE METHOD OF DATA COLLECTION. CONCLUSIONS: FINDINGS FROM THIS PILOT STUDY CONFIRM THE FEASIBILITY OF OFFERING YOGA TO THIS RACIALLY/ETHNICALLY DIVERSE POPULATION WITH ARTHRITIS. THIS ARTICLE PROVIDES RECRUITMENT/RETENTION RATES, OUTCOME MEASURES WITH ERROR RATES, AND DATA COLLECTION RECOMMENDATIONS FOR A PREVIOUSLY UNDER-REPRESENTED POPULATION. SUGGESTIONS INCLUDE ALLOCATING RESOURCES FOR TRANSLATION AND USING A MULTICULTURAL DESIGN TO FACILITATE RECRUITMENT AND RETENTION. TRIAL REGISTRATION: CLINICALTRIALS.GOV, NCT01617421.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
7 2532  35 YOGA EFFECTS ON MOOD AND QUALITY OF LIFE IN CHINESE WOMEN UNDERGOING HEROIN DETOXIFICATION: A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: YOGA, AS A MIND-BODY THERAPY, IS EFFECTIVE IN IMPROVING QUALITY OF LIFE FOR PATIENTS WITH CHRONIC DISEASES, YET LITTLE IS KNOWN ABOUT ITS EFFECTIVENESS IN FEMALE HEROIN ADDICTS. OBJECTIVES: THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECTS OF YOGA ON MOOD STATUS AND QUALITY OF LIFE AMONG WOMEN UNDERGOING DETOXIFICATION FOR HEROIN DEPENDENCE IN CHINA. METHOD: THIS STUDY WAS A RANDOMIZED CONTROLLED TRIAL. SEVENTY-FIVE WOMEN AGED 20-37 YEARS UNDERGOING DETOXIFICATION FOR HEROIN DEPENDENCE AT ANKANG HOSPITAL WERE ALLOCATED RANDOMLY INTO AN INTERVENTION OR A CONTROL GROUP. WOMEN IN THE INTERVENTION GROUP RECEIVED A 6-MONTH YOGA INTERVENTION IN ADDITION TO HOSPITAL ROUTINE CARE, AND WOMEN IN THE CONTROL GROUP RECEIVED HOSPITAL ROUTINE CARE ONLY. MOOD STATUS AND QUALITY OF LIFE WERE ASSESSED USING THE PROFILE OF MOOD STATES AND MEDICAL OUTCOMES STUDY 36-ITEM SHORT-FORM HEALTH SURVEY AT BASELINE AND FOLLOWING 3 AND 6 MONTHS OF TREATMENT. REPEATED-MEASURES ANALYSIS OF VARIANCE WAS USED TO EVALUATE TREATMENT AND TIME EFFECTS ON MOOD AND QUALITY OF LIFE. RESULTS: MOST FEMALE HEROIN ADDICTS WERE YOUNG AND SINGLE, WITH A LOW EDUCATION LEVEL. MOST HAD USED HEROIN BY INJECTION. MOOD STATE AND QUALITY OF LIFE OF FEMALE HEROIN ADDICTS WERE POOR. THE INTERVENTION GROUP SHOWED A SIGNIFICANT IMPROVEMENT IN MOOD STATUS AND QUALITY OF LIFE OVER TIME COMPARED WITH THEIR COUNTERPARTS IN THE CONTROL GROUP. CONCLUSION: YOGA MAY IMPROVE MOOD STATUS AND QUALITY OF LIFE FOR WOMEN UNDERGOING DETOXIFICATION FOR HEROIN DEPENDENCE. YOGA CAN BE USED AS AN AUXILIARY TREATMENT WITH TRADITIONAL HOSPITAL ROUTINE CARE FOR THESE WOMEN.	2013	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
8  945  46 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
9  312  45 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
10  551  37 CONVENIENT AND LIVE MOVEMENT (CALM) FOR WOMEN UNDERGOING BREAST CANCER TREATMENT: CHALLENGES AND RECOMMENDATIONS FOR INTERNET-BASED YOGA RESEARCH. OBJECTIVE: TO CONDUCT A PILOT TRIAL OF INTERNET-BASED, CANCER-ADAPTED YOGA FOR WOMEN RECEIVING BREAST CANCER TREATMENT. DESIGN: WOMEN UNDERGOING RADIATION OR CHEMOTHERAPY FOR BREAST CANCER WERE RECRUITED FOR 12, 75-MIN, BIWEEKLY, CANCER-ADAPTED YOGA CLASSES DELIVERED VIA INTERNET-BASED, MULTIPOINT VIDEOCONFERENCING. DATA WERE COLLECTED ON FEASIBILITY AND ACCEPTABILITY, INCLUDING QUALITATIVE FEEDBACK FROM PARTICIPANTS AND THE YOGA INSTRUCTOR. RESULTS: AMONG 42 WOMEN APPROACHED, 13 DECLINED ELIGIBILITY SCREENING, AND 23 WERE INELIGIBLE. ALL 6 WOMEN WHO WERE ELIGIBLE PROVIDED CONSENT, BUT 2 WITHDREW PRIOR TO BEGINNING YOGA CLASSES. THE REMAINING 4 PARTICIPANTS ATTENDED 1-11 OF 12 ONLINE YOGA CLASSES. IN POST-INTERVENTION INTERVIEWS, PARTICIPANTS AND THE INSTRUCTOR AGREED THAT INTERNET-BASED YOGA CLASSES HOLD GREAT POTENTIAL FOR INCREASING ACCESS AND IMPROVING PSYCHOLOGICAL OUTCOMES IN ADULTS WITH CANCER. QUALITATIVE FEEDBACK FROM PARTICIPANTS REVEALED SUGGESTIONS FOR FUTURE TRIALS OF INTERNET-BASED, CANCER-ADAPTED YOGA CLASSES, INCLUDING: CONTINUED USE OF GROUP FORMAT; OFFERING MORE VARIED CLASS TIMES TO ACCOMMODATE PATIENTS' DEMANDING SCHEDULES AND FLUCTUATING SYMPTOMS; ENROLLING PATIENTS AFTER THEY HAVE ACCLIMATED TO OR COMPLETED CANCER TREATMENT; STREAMLINING THE TECHNOLOGY INTERFACE; AND CAREFUL ATTENTION TO PARTICIPANT BURDEN WHEN DESIGNING SURVEYS/FORMS. THE INSTRUCTOR RECOMMENDED CLOSED SESSION COURSES, AS OPPOSED TO ROLLING ENROLLMENT; TEACHING THE SAME MODIFIED POSES FOR ALL PARTICIPANTS, RATHER THAN INDIVIDUAL TAILORING; AND USING A LARGE SCREEN TO ALLOW CLOSER MONITORING OF STUDENTS' CLASS EXPERIENCE. CONCLUSIONS: INTERNET DELIVERY MAY INCREASE PATIENTS' ACCESS TO CANCER-ADAPTED YOGA CLASSES, BUT CANCER-RELATED AND TECHNOLOGICAL BARRIERS REMAIN. THIS STUDY INFORMS HOW TO OPTIMALLY DESIGN YOGA CLASSES, TECHNOLOGY, AND RESEARCH PROCEDURES TO MAXIMIZE FEASIBILITY AND ACCEPTABILITY IN FUTURE TRIALS.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
11 2596  47 YOGA FOR MILITARY VETERANS WITH CHRONIC LOW BACK PAIN: A RANDOMIZED CLINICAL TRIAL. INTRODUCTION: CHRONIC LOW BACK PAIN (CLBP) IS PREVALENT, ESPECIALLY AMONG MILITARY VETERANS. MANY CLBP TREATMENT OPTIONS HAVE LIMITED BENEFITS AND ARE ACCOMPANIED BY SIDE EFFECTS. MAJOR EFFORTS TO REDUCE OPIOID USE AND EMBRACE NONPHARMACOLOGICAL PAIN TREATMENTS HAVE RESULTED. RESEARCH WITH COMMUNITY CLBP PATIENTS INDICATES THAT YOGA CAN IMPROVE HEALTH OUTCOMES AND HAS FEW SIDE EFFECTS. THE BENEFITS OF YOGA AMONG MILITARY VETERANS WERE EXAMINED. DESIGN: PARTICIPANTS WERE RANDOMIZED TO EITHER YOGA OR DELAYED YOGA TREATMENT IN 2013-2015. OUTCOMES WERE ASSESSED AT BASELINE, 6 WEEKS, 12 WEEKS, AND 6 MONTHS. INTENTION-TO-TREAT ANALYSES OCCURRED IN 2016. SETTING/PARTICIPANTS: ONE HUNDRED AND FIFTY MILITARY VETERANS WITH CLBP WERE RECRUITED FROM A MAJOR VETERANS AFFAIRS MEDICAL CENTER IN CALIFORNIA. INTERVENTION: YOGA CLASSES (WITH HOME PRACTICE) WERE LED BY A CERTIFIED INSTRUCTOR TWICE WEEKLY FOR 12 WEEKS, AND CONSISTED PRIMARILY OF PHYSICAL POSTURES, MOVEMENT, AND BREATHING TECHNIQUES. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES AFTER 12 WEEKS. PAIN INTENSITY WAS IDENTIFIED AS AN IMPORTANT SECONDARY OUTCOME. RESULTS: PARTICIPANT CHARACTERISTICS WERE MEAN AGE 53 YEARS, 26% WERE FEMALE, 35% WERE UNEMPLOYED OR DISABLED, AND MEAN BACK PAIN DURATION WAS 15 YEARS. IMPROVEMENTS IN ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES DID NOT DIFFER BETWEEN THE TWO GROUPS AT 12 WEEKS, BUT YOGA PARTICIPANTS HAD GREATER REDUCTIONS IN ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES THAN DELAYED TREATMENT PARTICIPANTS AT 6 MONTHS -2.48 (95% CI= -4.08, -0.87). YOGA PARTICIPANTS IMPROVED MORE ON PAIN INTENSITY AT 12 WEEKS AND AT 6 MONTHS. OPIOID MEDICATION USE DECLINED AMONG ALL PARTICIPANTS, BUT GROUP DIFFERENCES WERE NOT FOUND. CONCLUSIONS: YOGA IMPROVED HEALTH OUTCOMES AMONG VETERANS DESPITE EVIDENCE THEY HAD FEWER RESOURCES, WORSE HEALTH, AND MORE CHALLENGES ATTENDING YOGA SESSIONS THAN COMMUNITY SAMPLES STUDIED PREVIOUSLY. THE MAGNITUDE OF PAIN INTENSITY DECLINE WAS SMALL, BUT OCCURRED IN THE CONTEXT OF REDUCED OPIOID USE. THE FINDINGS SUPPORT WIDER IMPLEMENTATION OF YOGA PROGRAMS FOR VETERANS. TRIAL REGISTRATION: THIS STUDY IS REGISTERED AT WWW.CLINICALTRIALS.GOV NCT02524158.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
12 2477  39 YOGA AS AN ADJUNCTIVE INTERVENTION TO MEDICATION-ASSISTED TREATMENT WITH BUPRENORPHINE+NALOXONE. OBJECTIVE: ACCORDING TO THE CDC, 2.6 MILLION PEOPLE IN THE UNITED STATES HAVE AN OPIOID USE DISORDER AND DRUG OVERDOSE IS THE LEADING CAUSE OF ACCIDENTAL DEATH. OPIOIDS ARE INVOLVED IN 63% OF OVERDOSE DEATHS. IT IS IMPERATIVE THAT WE IDENTIFY EVIDENCE BASED TREATMENTS TO STEM THE TIDE OF THIS EPIDEMIC. THIS PILOT STUDY SERVES TO EXPLORE THE FEASIBILITY AND EFFECTIVENESS OF YOGA AS AN ADJUNCTIVE INTERVENTION FOR INDIVIDUALS WITH OPIOID USE DISORDER IN ACTIVE MEDICATION-ASSISTED TREATMENT (MAT). METHODS: PARTICIPANTS (N=26) WERE RECRUITED FROM A BUPRENORPHINE/NALOXONE MAT PROGRAM TO PARTICIPATE IN THIS STUDY. 13 PARTICIPANTS ENGAGED IN A 12 WEEK ADJUNCTIVE YOGA INTERVENTION WHILE REMAINING IN TREATMENT AS USUAL (TAU) MAT. 13 MATCHED CONTROLS WERE RECRUITED AND REMAINED IN TAU MAT. BOTH GROUPS WERE EVALUATED AT BASELINE, 45 DAYS AND 90 DAYS FOR CHANGES IN CRAVING FOR OPIOIDS, TREATMENT RETENTION, RELAPSE RATES, SLEEP, AND SYMPTOMS OF ANXIETY AND PERCEIVED STRESS. RESULTS: A TWO-WAY TREATMENT BY TIME ANALYSIS OF VARIANCE WAS PERFORMED USING A MIXED EFFECTS MODEL. THE TREATMENT BY FOLLOW-UP TIME INTERACTION EFFECT WAS SIGNIFICANT FOR PERCEIVED STRESS (P=0.026) INDICATING THAT THE YOGA INTERVENTION HAD A LARGER EFFECT THAN TAU (MAT). CHANGES IN PERCEIVED STRESS DECREASED SIGNIFICANTLY OVER TIME IN BOTH THE YOGA INTERVENTION GROUP AND THE TAU MAT MATCHED CONTROL GROUP. CONCLUSION: THIS PILOT STUDY INDICATED STRONG EVIDENCE FOR YOGA BEING AN EFFECTIVE ADJUNCTIVE TREATMENT TO MAT TAU IN REDUCING PERCEIVED STRESS. FURTHER RESEARCH WITH A LARGER POPULATION IS NEEDED TO DETERMINE IMPACT ON OTHER MENTAL HEALTH SYMPTOMS AND RELAPSE AND RETENTION RATES.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
13 1495  29 INTERVENTION PROTOCOL FOR INVESTIGATING YOGA IMPLEMENTED DURING CHEMOTHERAPY. OBJECTIVE: FATIGUE AND OTHER TREATMENT-RELATED SYMPTOMS ARE CRITICAL THERAPEUTIC TARGETS FOR IMPROVING QUALITY OF LIFE IN PATIENTS WITH COLORECTAL CANCER DURING CHEMOTHERAPY. YOGA IS A PROMISING INTERVENTION FOR IMPROVING THESE THERAPEUTIC TARGETS AND HAS BEEN PRIMARILY INVESTIGATED IN THE GROUP-CLASS FORMAT, WHICH IS LESS FEASIBLE FOR CANCER PATIENTS WITH HIGH SYMPTOM BURDEN TO ATTEND. THUS, WE DEVELOPED A PROTOCOL FOR IMPLEMENTING YOGA INDIVIDUALLY IN THE CLINIC AMONG PATIENTS RECEIVING CHEMOTHERAPY. METHODS: WE FOLLOWED RECOMMENDED DOMAINS FOR DEVELOPING A YOGA PROTOCOL TO BE USED IN AN EFFICACY TRIAL. THESE RECOMMENDATIONS INCLUDE CONSIDERATION TO THE STYLE, DELIVERY, COMPONENTS OF THE INTERVENTION, DOSE, SPECIFIC CLASS SEQUENCES, FACILITATION OF HOME PRACTICE, MEASUREMENT OF INTERVENTION FIDELITY, SELECTION OF INSTRUCTORS, AND DEALING WITH MODIFICATIONS. THE INTERVENTION PROTOCOL WAS DEVELOPED BY AN INTERDISCIPLINARY TEAM. PROTOCOL: YOGA SKILLS TRAINING (YST) CONSISTS OF FOUR 30-MINUTE IN-PERSON SESSIONS AND WAS IMPLEMENTED WHILE IN THE CHAIR DURING CHEMOTHERAPY INFUSIONS FOR COLORECTAL CANCER WITH RECOMMENDED DAILY HOME PRACTICE FOR EIGHT WEEKS. THERAPEUTIC GOALS OF THE YST ARE TO REDUCE FATIGUE, CIRCADIAN DISRUPTION, AND PSYCHOLOGICAL DISTRESS. ELEMENTS OF THE YST ARE AWARENESS MEDITATION, GENTLE SEATED MOVEMENT, BREATHING PRACTICE, AND RELAXATION MEDITATION. ATTENTION, COMFORT, AND EASE ARE ALSO HIGHLIGHTED. CONCLUSION: THIS DESCRIPTION OF A PROTOCOL FOR INTEGRATING YOGA WITH CONVENTIONAL CANCER TREATMENT WILL INFORM FUTURE STUDY DESIGNS AND CLINICAL PRACTICE. THE DESIGN OF THE YST IS NOVEL BECAUSE IT IMPLEMENTS YOGA-MOST COMMONLY STUDIED WHEN TAUGHT TO GROUPS OUTSIDE OF THE CLINICAL SETTING- INDIVIDUALLY DURING CLINICAL CARE.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
14 2763  31 YOGA PROGRAM FOR TYPE 2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE: QUALITATIVE STUDY TO EXPLORE REASONS FOR NON-PARTICIPATION IN A FEASIBILITY RANDOMIZED CONTROLLED TRIAL IN INDIA. BACKGROUND: YOGA-BASED INTERVENTIONS CAN BE EFFECTIVE IN PREVENTING TYPE 2 DIABETES MELLITUS (T2DM). WE DEVELOPED A YOGA PROGRAM FOR T2DM PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE AND CONDUCTED A FEASIBILITY RANDOMIZED CONTROLLED TRIAL (RCT) IN INDIA. THE OBJECTIVE OF THIS STUDY WAS TO IDENTIFY AND EXPLORE WHY POTENTIAL PARTICIPANTS DECLINED TO PARTICIPATE IN THE FEASIBILITY RCT. METHODS: AN EXPLORATORY QUALITATIVE STUDY, USING SEMI-STRUCTURED INTERVIEWS, WAS CONDUCTED AT A YOGA CENTER IN NEW DELHI, INDIA. FOURTEEN PEOPLE (10 WOMEN AND FOUR MEN) WHO DECLINED TO PARTICIPATE IN THE FEASIBILITY RCT WERE INTERVIEWED, AND 13 OF THEM COMPLETED THE NON-PARTICIPANT QUESTIONNAIRE, WHICH CAPTURED THEIR SOCIO-DEMOGRAPHICS, DIETS, PHYSICAL ACTIVITIES, AND REASONS FOR DECLINING. RESULTS: THREE TYPES OF BARRIERS WERE IDENTIFIED AND EXPLORED WHICH PREVENTED PARTICIPATION IN THE FEASIBILITY RCT: (1) PERSONAL BARRIERS, SUCH AS LACK OF TIME, PERCEIVED SUFFICIENCY OF KNOWLEDGE, PREFERENCES ABOUT SELF-MANAGEMENT OF HEALTH, AND TRUST IN OTHER TRADITIONAL AND ALTERNATIVE THERAPIES; (2) CONTEXTUAL BARRIERS, SUCH AS SOCIAL INFLUENCES AND LACK OF AWARENESS ABOUT PREVENTIVE CARE; AND (3) STUDY-RELATED BARRIERS, SUCH AS LACK OF STUDY INFORMATION, POOR ACCESSIBILITY TO THE YOGA SITE, AND LACK OF TRUST IN THE STUDY METHODS AND INTERVENTION. CONCLUSIONS: WE IDENTIFIED AND EXPLORED PERSONAL, CONTEXTUAL, AND STUDY-RELATED BARRIERS TO PARTICIPATION IN A FEASIBILITY RCT IN INDIA. THE FINDINGS WILL HELP TO ADDRESS RECRUITMENT CHALLENGES IN FUTURE YOGA AND OTHER RCTS. CLINICAL TRIAL REGISTRATION:WWW.CLINICALTRIALS.GOV, IDENTIFIER: CTRI/2019/05/018893.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
15   41  42 A BRIEF YOGA INTERVENTION IMPLEMENTED DURING CHEMOTHERAPY: A RANDOMIZED CONTROLLED PILOT STUDY. OBJECTIVES: FATIGUE AND OTHER TREATMENT-RELATED SYMPTOMS (E.G., SLEEP DISTURBANCE) ARE CRITICAL TARGETS FOR IMPROVING QUALITY OF LIFE IN PATIENTS UNDERGOING CHEMOTHERAPY. YOGA MAY REDUCE THE BURDEN OF SUCH SYMPTOMS. THIS STUDY INVESTIGATED THE FEASIBILITY OF CONDUCTING A RANDOMIZED CONTROLLED STUDY OF A BRIEF YOGA INTERVENTION DURING CHEMOTHERAPY FOR COLORECTAL CANCER. DESIGN: WE RANDOMIZED ADULTS WITH COLORECTAL CANCER TO A BRIEF YOGA SKILLS TRAINING (YST) OR AN ATTENTION CONTROL (AC; EMPATHIC ATTENTION AND RECORDED EDUCATION). SETTING: THE INTERVENTIONS AND ASSESSMENTS WERE IMPLEMENTED INDIVIDUALLY IN THE CLINIC WHILE PATIENTS WERE IN THE CHAIR RECEIVING CHEMOTHERAPY. INTERVENTIONS: BOTH INTERVENTIONS CONSISTED OF THREE SESSIONS AND RECOMMENDED HOME PRACTICE. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS FEASIBILITY (ACCRUAL, RETENTION, ADHERENCE, DATA COLLECTION). SELF-REPORTED OUTCOMES (I.E., FATIGUE, SLEEP DISTURBANCE, QUALITY OF LIFE) AND INFLAMMATORY BIOMARKERS WERE ALSO DESCRIBED TO INFORM FUTURE STUDIES. RESULTS: OF 52 PATIENTS INITIALLY IDENTIFIED, 28 WERE APPROACHED, AND 15 ENROLLED (AGE MEAN = 57.5 YEARS; 80% WHITE; 60% MALE). REASONS FOR DECLINING PARTICIPATION WERE: NOT INTERESTED (N = 6), DID NOT PERCEIVE A NEED (N = 2), AND OTHER (N = 5). TWO PARTICIPANTS WERE LOST TO FOLLOW-UP IN EACH GROUP DUE TO TREATMENT CHANGES. THUS, 75% OF PARTICIPANTS WERE RETAINED IN THE YST AND 71% IN THE AC ARM. PARTICIPANTS RETAINED IN THE STUDY ADHERED TO 97% OF THE IN-PERSON INTERVENTION SESSIONS AND COMPLETED ALL QUESTIONNAIRES. CONCLUSIONS: THIS STUDY DEMONSTRATED THE FEASIBILITY OF CONDUCTING A LARGER RANDOMIZED CONTROLLED TRIAL TO ASSESS YST AMONG PATIENTS RECEIVING CHEMOTHERAPY FOR COLORECTAL CANCER. DATA COLLECTED AND CHALLENGES ENCOUNTERED WILL INFORM FUTURE RESEARCH.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
16 2316  47 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	
                                                                                                                                                                                                                                                                                                                                                                  
17 2558  45 YOGA FOR CHRONIC LOW BACK PAIN IN A PREDOMINANTLY MINORITY POPULATION: A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: SEVERAL STUDIES SUGGEST YOGA MAY BE EFFECTIVE FOR CHRONIC LOW BACK PAIN; HOWEVER, TRIALS TARGETING MINORITIES HAVE NOT BEEN CONDUCTED. PRIMARY STUDY OBJECTIVES: ASSESS THE FEASIBILITY OF STUDYING YOGA IN A PREDOMINANTLY MINORITY POPULATION WITH CHRONIC LOW BACK PAIN. COLLECT PRELIMINARY DATA TO PLAN A LARGER POWERED STUDY. STUDY DESIGN: PILOT RANDOMIZED CONTROLLED TRIAL. SETTING: TWO COMMUNITY HEALTH CENTERS IN A RACIALLY DIVERSE NEIGHBORHOOD OF BOSTON, MASSACHUSETTS. PARTICIPANTS: THIRTY ENGLISH-SPEAKING ADULTS (MEAN AGE 44 YEARS, 83% FEMALE, 83% RACIAL/ETHNIC MINORITIES; 48% WITH INCOMES < OR = $30,000) WITH MODERATE-TO-SEVERE CHRONIC LOW BACK PAIN. INTERVENTIONS: STANDARDIZED SERIES OF WEEKLY HATHA YOGA CLASSES FOR 12 WEEKS COMPARED TO A WAITLIST USUAL CARE CONTROL. OUTCOME MEASURES: FEASIBILITY MEASURED BY TIME TO COMPLETE ENROLLMENT, PROPORTION OF RACIAL/ETHNIC MINORITIES ENROLLED, RETENTION RATES, AND ADVERSE EVENTS. PRIMARY EFFICACY OUTCOMES WERE CHANGES FROM BASELINE TO 12 WEEKS IN PAIN SCORE (0=NO PAIN TO 10=WORST POSSIBLE PAIN) AND BACK-RELATED FUNCTION USING THE MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE (0-23 POINT SCALE, HIGHER SCORES REFLECT POORER FUNCTION). SECONDARY EFFICACY OUTCOMES WERE ANALGESIC USE, GLOBAL IMPROVEMENT, AND QUALITY OF LIFE (SF-36). RESULTS: RECRUITMENT TOOK 2 MONTHS. RETENTION RATES WERE 97% AT 12 WEEKS AND 77% AT 26 WEEKS. MEAN PAIN SCORES FOR YOGA DECREASED FROM BASELINE TO 12 WEEKS (6.7 TO 4.4) COMPARED TO USUAL CARE, WHICH DECREASED FROM 7.5 TO 7.1 (P=.02). MEAN ROLAND SCORES FOR YOGA DECREASED FROM 14.5 TO 8.2 COMPARED TO USUAL CARE, WHICH DECREASED FROM 16.1 TO 12.5 (P=.28). AT 12 WEEKS, YOGA COMPARED TO USUAL CARE PARTICIPANTS REPORTED LESS ANALGESIC USE (13% VS 73%, P=.003), LESS OPIATE USE (0% VS 33%, P=.04), AND GREATER OVERALL IMPROVEMENT (73% VS 27%, P=.03). THERE WERE NO DIFFERENCES IN SF-36 SCORES AND NO SERIOUS ADVERSE EVENTS. CONCLUSION: A YOGA STUDY INTERVENTION IN A PREDOMINANTLY MINORITY POPULATION WITH CHRONIC LOW BACK PAIN WAS MODERATELY FEASIBLE AND MAY BE MORE EFFECTIVE THAN USUAL CARE FOR REDUCING PAIN AND PAIN MEDICATION USE.	2009	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
18 2389  45 YOGA AND AEROBIC DANCE FOR PAIN MANAGEMENT IN JUVENILE IDIOPATHIC ARTHRITIS: PROTOCOL FOR A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: JUVENILE IDIOPATHIC ARTHRITIS (JIA) IS ONE OF THE MOST COMMON TYPES OF ARTHRITIS AMONG CHILDREN. ACCORDING TO JIA GUIDELINES FOR PHYSICAL ACTIVITY (PA), STRUCTURED PA INTERVENTIONS LED TO IMPROVED HEALTH OUTCOMES. HOWEVER, MANY PA PROGRAMS, SUCH AS YOGA AND AEROBIC DANCE, HAVE NOT BEEN STUDIED IN THIS POPULATION DESPITE BEING POPULAR AMONG YOUTH. WEB-BASED PA PROGRAMS COULD PROVIDE PATIENTS WITH ACCESSIBLE AND AFFORDABLE INTERVENTIONS. OBJECTIVE: THE PRIMARY AIMS OF THE PROPOSED PILOT RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO EXAMINE (1) THE FEASIBILITY OF CONDUCTING A FULL-SCALE RCT TO EVALUATE THE EFFECTIVENESS OF TWO POPULAR TYPES OF PA: A YOGA TRAINING PROGRAM AND AN AEROBIC DANCE TRAINING PROGRAM, IN FEMALE ADOLESCENTS (AGED 13-18 YEARS) WITH JIA COMPARED WITH AN ELECTRONIC PAMPHLET CONTROL GROUP; AND (2) THE ACCEPTABILITY OF THESE INTERVENTIONS. METHODS: A THREE-ARM PROSPECTIVE RANDOMIZED OPEN-LABEL STUDY WITH A PARALLEL GROUP DESIGN WILL BE USED. A TOTAL OF 25 FEMALE ADOLESCENTS WITH JIA WHO HAVE PAIN WILL BE RANDOMIZED IN A RATIO OF 2:2:1 TO ONE OF THE 3 GROUPS: (1) ONLINE YOGA TRAINING PROGRAM (GROUP A: N=10); (2) ONLINE AEROBIC DANCE TRAINING PROGRAM (GROUP B: N=10); AND (3) ELECTRONIC PAMPHLET CONTROL GROUP (GROUP C: N=5). PARTICIPANTS IN GROUPS A AND B WILL COMPLETE 3 INDIVIDUAL 1-HOUR SESSIONS PER WEEK USING ONLINE EXERCISE VIDEOS, AS WELL AS A 1-HOUR VIRTUAL GROUP SESSION PER WEEK USING A VIDEOCONFERENCING PLATFORM FOR 12 WEEKS. PARTICIPANTS FROM ALL GROUPS WILL HAVE ACCESS TO AN ELECTRONIC EDUCATIONAL PAMPHLET ON PA FOR ARTHRITIS DEVELOPED BY THE ARTHRITIS SOCIETY. ALL PARTICIPANTS WILL ALSO TAKE PART IN WEEKLY ONLINE CONSULTATIONS WITH A RESEARCH COORDINATOR AND DISCUSSIONS ON FACEBOOK WITH PARTICIPANTS FROM THEIR OWN GROUP. FEASIBILITY (IE, RECRUITMENT RATE, SELF-REPORTED ADHERENCE TO THE INTERVENTIONS, DROPOUT RATES, AND PERCENTAGE OF MISSING DATA), ACCEPTABILITY, AND USABILITY OF FACEBOOK AND THE VIDEOCONFERENCING PLATFORM WILL BE ASSESSED AT THE END OF THE PROGRAM. PAIN INTENSITY, PARTICIPATION IN GENERAL PA, MORNING STIFFNESS, FUNCTIONAL STATUS, FATIGUE, SELF-EFFICACY, PATIENT GLOBAL ASSESSMENT, DISEASE ACTIVITY, AND ADVERSE EVENTS WILL BE ASSESSED USING SELF-ADMINISTERED ELECTRONIC SURVEYS AT BASELINE AND THEN WEEKLY UNTIL THE END OF THE 12-WEEK PROGRAM. RESULTS: THIS PILOT RCT HAS BEEN FUNDED BY THE ARTHRITIS HEALTH PROFESSIONS ASSOCIATION. THIS PROTOCOL WAS APPROVED BY THE CHILDREN'S HOSPITAL OF EASTERN ONTARIO RESEARCH ETHICS BOARD (#17/08X). AS OF MAY 11, 2020, RECRUITMENT AND DATA COLLECTION HAVE NOT STARTED. CONCLUSIONS: TO OUR KNOWLEDGE, THIS IS THE FIRST STUDY TO EVALUATE THE EFFECTIVENESS OF YOGA AND AEROBIC DANCE AS PAIN MANAGEMENT INTERVENTIONS FOR FEMALE ADOLESCENTS WITH JIA. THE USE OF ONLINE PROGRAMS TO DISSEMINATE THESE 2 PA INTERVENTIONS MAY FACILITATE ACCESS TO ALTERNATIVE METHODS OF PAIN MANAGEMENT. THIS STUDY CAN LEAD TO A FULL-SCALE RCT. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/12823.	2020	
                                                                                                                                             
19  144  31 A QUALITATIVE APPROACH EXPLORING THE ACCEPTABILITY OF YOGA FOR MINORITIES LIVING WITH ARTHRITIS: 'WHERE ARE THE PEOPLE WHO LOOK LIKE ME?' OBJECTIVES: TO EXAMINE THE ACCEPTABILITY OF YOGA RESEARCH TAILORED TO RECRUIT AND RETAIN A MINORITY POPULATION (BOTH ENGLISH AND SPANISH SPEAKING) WITH ARTHRITIS. YOGA RESEARCH FOR ARTHRITIS OFTEN UNDERREPRESENTS MINORITIES AND ACCEPTABILITY FOR THIS POPULATION HAS NOT PREVIOUSLY BEEN INVESTIGATED. DESIGN: ACCEPTABILITY WAS EVALUATED USING RETENTION, ADHERENCE, JOURNALS, AND SEMI-STRUCTURED EXIT INTERVIEWS FROM TWELVE PARTICIPANTS WITH OSTEOARTHRITIS OR RHEUMATOID ARTHRITIS UNDERGOING AN 8-WEEK YOGA INTERVENTION. JOURNAL QUOTES WERE ANALYZED USING CONTENT ANALYSIS TECHNIQUES. NVIVO SOFTWARE WAS USED TO ORGANIZE TRANSCRIPTS AND ASSEMBLE THEMES. TWO METHODS OF TRIANGULATION (DATA AND INVESTIGATOR) WERE USED TO OVERCOME POTENTIAL BIAS FROM A SINGLE-PERSPECTIVE INTERPRETATION. EXIT INTERVIEW COMMENTS WERE CONTENT ANALYZED USING A CARD SORT METHOD. THE STUDY WAS DESIGNED WITH A CULTURAL INFRASTRUCTURE INCLUDING A MULTICULTURAL RESEARCH TEAM, TRANSLATORS, AND BILINGUAL MATERIALS AND CLASSES, TO FACILITATE TRUST AND ACCEPTABILITY FOR PRIMARILY HISPANIC AND BLACK/AFRICAN-AMERICAN ADULTS. SETTING: WASHINGTON, D.C. METROPOLITAN AREA, USA. RESULTS: ON AVERAGE PARTICIPANTS ATTENDED 10 OF 16 CLASSES, WITH HOME PRACTICE 2-3DAYS A WEEK. ALL WHO COMPLETED WERE STILL PRACTICING YOGA THREE-MONTHS LATER. QUALITATIVE NARRATIVE ANALYSIS IDENTIFIED MAJOR THEMES RELATED TO FACILITATING FACTORS AND BARRIERS FOR YOGA PRACTICE, SELF-EFFICACY, AND SUPPORT. PARTICIPANT COMMENTS INDICATED THAT OFFERING AN ARTHRITIS-BASED YOGA INTERVENTION AND USING A CULTURALLY CONGRUENT RESEARCH DESIGN WAS FOUND TO BE ACCEPTABLE. CONCLUSIONS: AS YOGA RESEARCH GROWS, THERE IS A NEED TO UNDERSTAND AND PROMOTE ACCEPTABILITY FOR TYPICALLY UNDER-REPRESENTED POPULATIONS. THIS STUDY ATTEMPTS TO INFORM THE EXPANSION OF MULTICULTURAL RESEARCH DESIGNED TO RECRUIT AND RETAIN THOSE FROM DIVERSE BACKGROUNDS.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
20   91  38 A MULTICOMPONENT YOGA-BASED, BREATH INTERVENTION PROGRAM AS AN ADJUNCTIVE TREATMENT IN PATIENTS SUFFERING FROM GENERALIZED ANXIETY DISORDER WITH OR WITHOUT COMORBIDITIES. OBJECTIVES: THE AIM OF THIS STUDY IS TO EVALUATE THE EFFICACY AND TOLERABILITY OF SUDARSHAN KRIYA YOGA (SKY) COURSE IN GENERALIZED ANXIETY DISORDER (GAD) OUTPATIENTS, WHO AFTER EIGHT WEEKS OF AN APPROPRIATE DOSE OF TRADITIONAL THERAPY HAD NOT YET ACHIEVED REMISSION. SUBJECTS: THE ADULT PARTICIPANTS (18-65 YEARS) WERE OUTPATIENTS WITH A PRIMARY DIAGNOSIS OF GAD WITH OR WITHOUT COMORBIDITIES ON THE MINI-INTERNATIONAL NEUROPSYCHIATRIC INTERVIEW (MINI). PARTICIPANTS HAD A MINIMUM OF EIGHT WEEKS STANDARD TREATMENT WITH AN APPROPRIATE DOSE OF A STANDARD PRESCRIPTION ANXIOLYTIC, A CLINICIAN GLOBAL IMPRESSION-SEVERITY (CGI-S) SCORE OF 5-7, A HAMILTON ANXIETY SCALE (HAM-A) TOTAL SCORE >/=20 INCLUDING A SCORE OF >2 ON THE ANXIOUS MOOD AND TENSION ITEMS. MATERIALS AND METHODS: FORTY-ONE PATIENTS WERE ENROLLED IN AN OPEN-LABEL TRIAL OF THE SKY COURSE AS AN ADJUNCT TO STANDARD TREATMENT OF GAD AT THE START CLINIC FOR MOOD AND ANXIETY DISORDERS, A TERTIARY CARE MOOD AND ANXIETY DISORDER CLINIC IN TORONTO. THE SKY COURSE WAS ADMINISTERED OVER FIVE DAYS (22 H TOTAL). SUBJECTS WERE ENCOURAGED TO PRACTICE THE YOGA BREATHING TECHNIQUES AT HOME FOR 20 MIN PER DAY AFTER THE COURSE AND WERE OFFERED GROUP PRACTICE SESSIONS FOR 2 H ONCE A WEEK LED BY CERTIFIED YOGA INSTRUCTORS. THE PRIMARY OUTCOME MEASURE WAS THE MEAN CHANGE FROM PRE-TREATMENT ON THE HAM-A SCALE. PSYCHOLOGICAL MEASURES WERE OBTAINED AT BASELINE AND FOUR WEEKS AFTER COMPLETING THE INTERVENTION. RESULTS: THIRTY-ONE PATIENTS COMPLETED THE PROGRAM (MEAN AGE 42.6 +/- 13.3 YEARS). AMONG COMPLETERS, SIGNIFICANT REDUCTIONS OCCURRED IN THE PRE- AND POST-INTERVENTION MEAN HAM-A TOTAL SCORE (T=4.59; P<0.01) AND PSYCHIC SUBSCALE (T=5.00; P</=0.01). THE RESPONSE RATE WAS 73% AND THE REMISSION RATE 41% AS MEASURED ON THE HAM-A. CONCLUSION: THE RESULTS OF THIS SMALL PILOT TRIAL SUGGEST THAT THE SKY COURSE REPRESENTS A POTENTIALLY VALUABLE ADJUNCT TO STANDARD PHARMACOTHERAPY IN PATIENTS WITH GAD OR TREATMENT-RESISTANT GAD, AND WARRANTS FURTHER INVESTIGATION. IN PARTICULAR, CHANGES IN WORRY AND BODY SYMPTOMS SHOWED SIGNIFICANT IMPROVEMENTS THAT MAY FURTHER OUR UNDERSTANDING OF THE MECHANISM OF CHANGE IN THE TOLERANCE OF ANXIETY AND WORRY.	2012