1 517 153 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 2 109 41 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 3 2596 53 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 4 172 35 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 5 345 39 ASSESSING FEASIBILITY AND ACCEPTABILITY OF YOGA AND GROUP CBT FOR ADOLESCENTS WITH DEPRESSION: A PILOT RANDOMIZED CLINICAL TRIAL. PURPOSE: GIVEN INCREASING RATES OF DEPRESSION IN ADOLESCENTS, THERE IS A CLEAR NEED FOR INNOVATIVE TREATMENTS. IN THIS PILOT RANDOMIZED CLINICAL TRIAL, WE ASSESSED ACCEPTABILITY AND FEASIBILITY OF TWO GROUP-BASED INTERVENTIONS: YOGA AND COGNITIVE-BEHAVIORAL THERAPY (CBT). THE GOAL OF THIS WORK IS TO PREPARE FOR A FUTURE FULLY POWERED RANDOMIZED TRIAL TO TEST THE HYPOTHESIS THAT YOGA IS NOT INFERIOR TO AN ESTABLISHED ADOLESCENT DEPRESSION TREATMENT, NAMELY, GROUP CBT. METHODS: WE ENROLLED 42 ADOLESCENTS WITH ELEVATED DEPRESSION SYMPTOMS. PARTICIPANTS WERE RANDOMLY ASSIGNED TO A 12-WEEK GROUP-BASED INTERVENTION, YOGA OR CBT. WE HAD A PRIORI FEASIBILITY AND ACCEPTABILITY TARGETS, INCLUDING FOR RECRUITMENT RATE, RETENTION RATE, EXPECTANCY, CREDIBILITY, PROGRAM SATISFACTION, CLASS ATTENDANCE, ENGAGEMENT IN HOME PRACTICE, AND INSTRUCTOR/LEADER MANUAL ADHERENCE. WE ASSESSED ADVERSE EVENTS, AND WITHIN-SUBJECT CHANGES IN OUTCOMES (DEPRESSION, ANXIETY, IMPAIRMENT, SLEEP DISTURBANCE) AND POSSIBLE MEDIATORS (MINDFULNESS, SELF-COMPASSION). RESULTS: BOTH INTERVENTIONS MET MOST ACCEPTABILITY AND FEASIBILITY TARGETS. THE ONLY TARGET NOT MET RELATED TO LOW ENGAGEMENT IN HOME PRACTICE. PARTICIPANTS WITHIN EACH STUDY ARM SHOWED DECREASED DEPRESSION SYMPTOMS OVER TIME AND INCREASED SELF-COMPASSION. CONCLUSIONS: A YOGA INTERVENTION APPEARS TO BE ACCEPTABLE AND FEASIBLE TO ADOLESCENTS WITH DEPRESSION. HOWEVER, IT MAY BE CHALLENGING FOR THIS GROUP TO ENGAGE IN UNSTRUCTURED HOME PRACTICE. 2022 6 312 41 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 7 2477 42 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 8 2852 50 YOGA, PHYSICAL THERAPY, OR EDUCATION FOR CHRONIC LOW BACK PAIN: A RANDOMIZED NONINFERIORITY TRIAL. BACKGROUND: YOGA IS EFFECTIVE FOR MILD TO MODERATE CHRONIC LOW BACK PAIN (CLBP), BUT ITS COMPARATIVE EFFECTIVENESS WITH PHYSICAL THERAPY (PT) IS UNKNOWN. MOREOVER, LITTLE IS KNOWN ABOUT YOGA'S EFFECTIVENESS IN UNDERSERVED PATIENTS WITH MORE SEVERE FUNCTIONAL DISABILITY AND PAIN. OBJECTIVE: TO DETERMINE WHETHER YOGA IS NONINFERIOR TO PT FOR CLBP. DESIGN: 12-WEEK, SINGLE-BLIND, 3-GROUP RANDOMIZED NONINFERIORITY TRIAL AND SUBSEQUENT 40-WEEK MAINTENANCE PHASE. (CLINICALTRIALS.GOV: NCT01343927). SETTING: ACADEMIC SAFETY-NET HOSPITAL AND 7 AFFILIATED COMMUNITY HEALTH CENTERS. PARTICIPANTS: 320 PREDOMINANTLY LOW-INCOME, RACIALLY DIVERSE ADULTS WITH NONSPECIFIC CLBP. INTERVENTION: PARTICIPANTS RECEIVED 12 WEEKLY YOGA CLASSES, 15 PT VISITS, OR AN EDUCATIONAL BOOK AND NEWSLETTERS. THE MAINTENANCE PHASE COMPARED YOGA DROP-IN CLASSES VERSUS HOME PRACTICE AND PT BOOSTER SESSIONS VERSUS HOME PRACTICE. MEASUREMENTS: PRIMARY OUTCOMES WERE BACK-RELATED FUNCTION, MEASURED BY THE ROLAND MORRIS DISABILITY QUESTIONNAIRE (RMDQ), AND PAIN, MEASURED BY AN 11-POINT SCALE, AT 12 WEEKS. PRESPECIFIED NONINFERIORITY MARGINS WERE 1.5 (RMDQ) AND 1.0 (PAIN). SECONDARY OUTCOMES INCLUDED PAIN MEDICATION USE, GLOBAL IMPROVEMENT, SATISFACTION WITH INTERVENTION, AND HEALTH-RELATED QUALITY OF LIFE. RESULTS: ONE-SIDED 95% LOWER CONFIDENCE LIMITS WERE 0.83 (RMDQ) AND 0.97 (PAIN), DEMONSTRATING NONINFERIORITY OF YOGA TO PT. HOWEVER, YOGA WAS NOT SUPERIOR TO EDUCATION FOR EITHER OUTCOME. YOGA AND PT WERE SIMILAR FOR MOST SECONDARY OUTCOMES. YOGA AND PT PARTICIPANTS WERE 21 AND 22 PERCENTAGE POINTS LESS LIKELY, RESPECTIVELY, THAN EDUCATION PARTICIPANTS TO USE PAIN MEDICATION AT 12 WEEKS. IMPROVEMENTS IN YOGA AND PT GROUPS WERE MAINTAINED AT 1 YEAR WITH NO DIFFERENCES BETWEEN MAINTENANCE STRATEGIES. FREQUENCY OF ADVERSE EVENTS, MOSTLY MILD SELF-LIMITED JOINT AND BACK PAIN, DID NOT DIFFER BETWEEN THE YOGA AND PT GROUPS. LIMITATIONS: PARTICIPANTS WERE NOT BLINDED TO TREATMENT ASSIGNMENT. THE PT GROUP HAD DISPROPORTIONATE LOSS TO FOLLOW-UP. CONCLUSION: A MANUALIZED YOGA PROGRAM FOR NONSPECIFIC CLBP WAS NONINFERIOR TO PT FOR FUNCTION AND PAIN. PRIMARY FUNDING SOURCE: NATIONAL CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH OF THE NATIONAL INSTITUTES OF HEALTH. 2017 9 74 40 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 10 465 41 CHARACTERISTICS AND PREDICTORS OF SHORT-TERM OUTCOMES IN INDIVIDUALS SELF-SELECTING YOGA OR PHYSICAL THERAPY FOR TREATMENT OF CHRONIC LOW BACK PAIN. OBJECTIVE: TO COMPARE CLINICAL AND DEMOGRAPHIC CHARACTERISTICS OF INDIVIDUALS SELF-SELECTING YOGA OR PHYSICAL THERAPY (PT) FOR TREATMENT OF CHRONIC LOW BACK PAIN (CLBP) AND TO EXAMINE PREDICTORS OF SHORT-TERM PAIN AND FUNCTIONAL OUTCOMES. DESIGN: DESCRIPTIVE, LONGITUDINAL STUDY. SETTINGS: A HOSPITAL-BASED CLINIC THAT OFFERS MODIFIED INTEGRAL YOGA CLASSES FOR CLBP AND 2 OUTPATIENT PT CLINICS THAT OFFER EXERCISE-BASED PT. PARTICIPANTS: ADULTS (N=53) WITH CLBP>/=12 WEEKS: YOGA (N=27), PT (N=26). METHODS: YOGA PARTICIPANTS ATTENDED A 6-WEEK, ONCE WEEKLY, 2-HOUR YOGA CLASS. PT PARTICIPANTS UNDERWENT TWICE WEEKLY, 1-HOUR INDIVIDUALIZED PT. DATA WERE COLLECTED AT BASELINE AND AT 6 WEEKS. GROUPS WERE COMPARED BY USING CHI2 AND INDEPENDENT SAMPLES T-TESTS. HIERARCHICAL LINEAR REGRESSION WAS USED TO PREDICT TREATMENT OUTCOMES. MAIN OUTCOME MEASURES: DISABILITY (ROLAND MORRIS DISABILITY QUESTIONNAIRE), HEALTH STATUS (RAND SHORT FORM 36 HEALTH SURVEY 1.0), PAIN BOTHERSOMENESS (NUMERICAL RATING SCALE), BACK PAIN SELF-EFFICACY (BACK PAIN SELF-EFFICACY SCALE), AND TREATMENT SATISFACTION. RESULTS: AT BASELINE, YOGA PARTICIPANTS WERE SIGNIFICANTLY LESS DISABLED (P=.013), HAD HIGHER HEALTH STATUS (P=.023), GREATER PAIN SELF-EFFICACY (P=.012), AND LESS AVERAGE PAIN BOTHERSOMENESS (P=.001) COMPARED WITH PT PARTICIPANTS. AT 6 WEEKS, WHEN CONTROLLING FOR BASELINE GROUP DIFFERENCES, GREATER PAIN SELF-EFFICACY WAS THE STRONGEST PREDICTOR FOR REDUCED PAIN AND HIGHER FUNCTION FOR THE ENTIRE SAMPLE. A SIGNIFICANT GROUP INTERACTION BY BASELINE PAIN SELF-EFFICACY PREDICTED DISABILITY AT 6 WEEKS. PT PARTICIPANTS WITH LOW PAIN SELF-EFFICACY REPORTED SIGNIFICANTLY GREATER DISABILITY THAN THOSE WITH HIGH PAIN SELF-EFFICACY. YOGA PARTICIPANTS WITH LOW AND HIGH PAIN SELF-EFFICACY HAD SIMILAR DISABILITY OUTCOMES. CONCLUSION: THESE FINDINGS STRENGTHEN EVIDENCE THAT SELF-EFFICACY IS ASSOCIATED WITH CLBP OUTCOMES, ESPECIALLY IN INDIVIDUALS SELF-SELECTING PT. FURTHER RESEARCH TO EVALUATE OUTCOMES AFTER YOGA AND PT IN PARTICIPANTS WITH LOW PAIN SELF-EFFICACY IS NEEDED. 2010 11 2558 40 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 12 2782 38 YOGA THERAPY AS AN ADD-ON TREATMENT IN THE MANAGEMENT OF PATIENTS WITH SCHIZOPHRENIA--A RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: TREATMENT OF SCHIZOPHRENIA HAS REMAINED UNSATISFACTORY DESPITE THE AVAILABILITY OF ANTIPSYCHOTICS. THIS STUDY EXAMINED THE EFFICACY OF YOGA THERAPY (YT) AS AN ADD-ON TREATMENT TO THE ONGOING ANTIPSYCHOTIC TREATMENT. METHOD: SIXTY-ONE MODERATELY ILL SCHIZOPHRENIA PATIENTS WERE RANDOMLY ASSIGNED TO YT (N = 31) AND PHYSICAL EXERCISE THERAPY (PT; N = 30) FOR 4 MONTHS. THEY WERE ASSESSED AT BASELINE AND 4 MONTHS AFTER THE START OF INTERVENTION, BY A RATER WHO WAS BLIND TO THEIR GROUP STATUS. RESULTS: FORTY-ONE SUBJECTS (YT = 21; PT = 20) WERE AVAILABLE AT THE END OF 4 MONTHS FOR ASSESSMENT. SUBJECTS IN THE YT GROUP HAD SIGNIFICANTLY LESS PSYCHOPATHOLOGY THAN THOSE IN THE PT GROUP AT THE END OF 4 MONTHS. THEY ALSO HAD SIGNIFICANTLY GREATER SOCIAL AND OCCUPATIONAL FUNCTIONING AND QUALITY OF LIFE. CONCLUSION: BOTH NON-PHARMACOLOGICAL INTERVENTIONS CONTRIBUTE TO REDUCTION IN SYMPTOMS, WITH YT HAVING BETTER EFFICACY. 2007 13 1787 46 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 2320 48 TREATMENT CREDIBILITY, EXPECTANCY, AND PREFERENCE: PREDICTION OF TREATMENT ENGAGEMENT AND OUTCOME IN A RANDOMIZED CLINICAL TRIAL OF HATHA YOGA VS. HEALTH EDUCATION AS ADJUNCT TREATMENTS FOR DEPRESSION. BACKGROUND: HATHA YOGA MAY BE HELPFUL FOR ALLEVIATING DEPRESSION SYMPTOMS. THE PURPOSE OF THIS ANALYSIS IS TO DETERMINE WHETHER TREATMENT PROGRAM PREFERENCE, CREDIBILITY, OR EXPECTANCY PREDICT ENGAGEMENT IN DEPRESSION INTERVENTIONS (YOGA OR A CONTROL CLASS) OR DEPRESSION SYMPTOM SEVERITY OVER TIME. METHODS: THIS IS A SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL (RCT) OF HATHA YOGA VS. A HEALTH EDUCATION CONTROL GROUP FOR TREATMENT OF DEPRESSION. DEPRESSED PARTICIPANTS (N=122) ATTENDED UP TO 20 CLASSES OVER A PERIOD OF 10 WEEKS, AND THEN COMPLETED ADDITIONAL ASSESSMENTS AFTER 3 AND 6 MONTHS. WE ASSESSED TREATMENT PREFERENCE PRIOR TO RANDOMIZATION, AND TREATMENT CREDIBILITY AND EXPECTANCY AFTER PARTICIPANTS ATTENDED THEIR FIRST CLASS. TREATMENT "CONCORDANCE" INDICATED THAT TREATMENT PREFERENCE MATCHED ASSIGNED TREATMENT. RESULTS: TREATMENT CREDIBILITY, EXPECTANCY, AND CONCORDANCE WERE NOT ASSOCIATED WITH TREATMENT ENGAGEMENT. TREATMENT EXPECTANCY MODERATED THE ASSOCIATION BETWEEN TREATMENT GROUP AND DEPRESSION. DEPRESSION SEVERITY OVER TIME DIFFERED BY EXPECTANCY LEVEL FOR THE YOGA GROUP BUT NOT FOR THE HEALTH EDUCATION GROUP. CONTROLLING FOR BASELINE DEPRESSION, PARTICIPANTS IN THE YOGA GROUP WITH AN AVERAGE OR HIGH EXPECTANCY FOR IMPROVEMENT SHOWED LOWER DEPRESSION SYMPTOMS ACROSS THE ACUTE INTERVENTION AND FOLLOW-UP PERIOD THAN THOSE WITH A LOW EXPECTANCY FOR IMPROVEMENT. THERE WAS A TREND FOR A SIMILAR PATTERN FOR CREDIBILITY. CONCORDANCE WAS NOT ASSOCIATED WITH TREATMENT OUTCOME. LIMITATIONS: THIS IS A SECONDARY, POST-HOC ANALYSIS AND SHOULD BE CONSIDERED HYPOTHESIS-GENERATING. CONCLUSIONS: RESULTS SUGGEST THAT EXPECTANCY IMPROVES THE LIKELIHOOD OF SUCCESS ONLY FOR A INTERVENTION THOUGHT TO ACTIVELY TARGET DEPRESSION (YOGA) AND NOT A CONTROL INTERVENTION. 2018 15 70 44 A FEASIBILITY STUDY EXAMINING THE IMPACT OF YOGA ON PSYCHOSOCIAL HEALTH AND SYMPTOMS IN PEDIATRIC OUTPATIENTS RECEIVING CHEMOTHERAPY. PURPOSE: PEDIATRIC CANCER PATIENTS EXPERIENCE SYMPTOMS THAT NEGATIVELY IMPACT QUALITY OF LIFE; YOGA MAY BE AN EFFECTIVE INTERVENTION. THE PRIMARY OBJECTIVE WAS TO DETERMINE THE FEASIBILITY OF A 10-WEEK, WEEKLY INDIVIDUALIZED YOGA INTERVENTION FOR CHILDREN AND ADOLESCENTS RECEIVING OUTPATIENT CANCER THERAPY PRIMARILY DELIVERED REMOTELY USING SKYPE. SECONDARY OBJECTIVES WERE TO DESCRIBE DEPRESSION, ANXIETY, ANGER, FATIGUE, QUALITY OF LIFE, AND SYMPTOMS AT 5 AND 10 WEEKS AFTER ENROLLMENT. METHODS: WE INCLUDED ENGLISH-SPEAKING PATIENTS AGED 10 TO 18 YEARS RECEIVING OUTPATIENT CHEMOTHERAPY FOR CANCER. WEEKLY INDIVIDUALIZED YOGA SESSIONS WERE OFFERED FOR 10 WEEKS. WEEKS 1, 5, AND 10 WERE IN-HOSPITAL WHILE THE REMAINING SESSIONS WERE DELIVERED REMOTELY USING SKYPE. TWICE WEEKLY, HOMEWORK WAS ASSIGNED BETWEEN EACH SESSION. THE PRIMARY OUTCOME WAS FEASIBILITY, DEFINED AS 80% OF PARTICIPANTS COMPLETING AT LEAST 60% OF PLANNED IN-HOSPITAL OR REMOTE YOGA SESSIONS. RESULTS: BETWEEN MARCH AND NOVEMBER 2017, 10 PATIENTS WERE ENROLLED. TWO PATIENTS DISCONTINUED THE STUDY AFTER ONE AND TWO SESSIONS. ONLY SIX PARTICIPANTS ACHIEVED AT LEAST 60% OF PLANNED YOGA SESSIONS AND THUS, THE STUDY DID NOT MEET THE A PRIORI DEFINED FEASIBILITY THRESHOLD. AMONG ALL PARTICIPANTS, ONLY ONE HOMEWORK SESSION WAS PERFORMED. CONCLUSIONS: A 10-WEEK INDIVIDUALIZED IN-PERSON AND REMOTELY CONDUCTED YOGA INTERVENTION WAS NOT FEASIBLE IN CHILDREN RECEIVING CANCER TREATMENTS BECAUSE OF FAILURE TO ACHIEVE THE DESIRED FREQUENCY OF YOGA SESSIONS IN A SUFFICIENT NUMBER OF PARTICIPANTS. FUTURE RESEARCH SHOULD IDENTIFY APPROACHES TO IMPROVE COMPLIANCE WITH REMOTE YOGA SESSIONS AND HOME PRACTICE. TRIAL REGISTRATION: NCT03318068. 2019 16 1960 52 SELF-REGULATION EVALUATION OF THERAPEUTIC YOGA AND WALKING FOR PATIENTS WITH IRRITABLE BOWEL SYNDROME: A PILOT STUDY. WITH LIMITED EFFICACY OF MEDICATIONS FOR SYMPTOM RELIEF, NON-MEDICATION TREATMENTS MAY PLAY AN IMPORTANT ROLE IN THE TREATMENT OF IRRITABLE BOWEL SYNDROME (IBS), THE MOST COMMON FUNCTIONAL GASTROINTESTINAL (GI) DISORDER. THIS STUDY AIMED TO EVALUATE THE EFFICACY OF TWO SELF-REGULATION STRATEGIES FOR SYMPTOM RELIEF AND MOOD MANAGEMENT IN IBS PATIENTS. THIRTY-FIVE ADULT PARTICIPANTS MEETING ROME III CRITERIA FOR IBS WERE ENROLLED, 27 OF THE 35 PARTICIPANTS (77%) COMPLETED TREATMENT AND PRE- AND POST-TREATMENT VISITS (89% WOMEN, 11% MEN; M (SD) AGE = 36 (13)), AND 20 OF THE 27 (74%) COMPLETED A 6-MONTH FOLLOW-UP. PARTICIPANTS WERE RANDOMLY ASSIGNED TO 16 BIWEEKLY GROUP SESSIONS OF IYENGAR YOGA OR A WALKING PROGRAM. RESULTS INDICATED A SIGNIFICANT GROUP BY TIME INTERACTION ON NEGATIVE AFFECT WITH THE WALKING TREATMENT SHOWING IMPROVEMENT FROM PRE- TO POST-TREATMENT WHEN COMPARED TO YOGA (P < .05). THERE WAS NO SIGNIFICANT GROUP BY TIME EFFECT ON IBS SEVERITY. EXPLORATORY ANALYSES OF SECONDARY OUTCOMES EXAMINED CHANGE SEPARATELY FOR EACH TREATMENT CONDITION. FROM PRE- TO POST-TREATMENT, YOGA SHOWED SIGNIFICANT DECREASES IN IBS SEVERITY MEASURES (P < .05), VISCERAL SENSITIVITY (P < .05), AND SEVERITY OF SOMATIC SYMPTOMS (P < .05). WALKING SHOWED SIGNIFICANT DECREASES IN OVERALL GI SYMPTOMS (P < .05), NEGATIVE AFFECT (P < .05), AND STATE ANXIETY (P < .05). AT 6-MONTH FOLLOW-UP, OVERALL GI SYMPTOMS FOR WALKING CONTINUED TO SIGNIFICANTLY DECLINE, WHILE FOR YOGA, GI SYMPTOMS REBOUNDED TOWARD BASELINE LEVELS (P < .05). WHEN ASKED ABOUT SELF-REGULATED HOME PRACTICE AT 6 MONTHS, SIGNIFICANTLY MORE PARTICIPANTS IN WALKING THAN IN YOGA PRACTICED AT LEAST WEEKLY (P < .05). IN SUM, RESULTS SUGGEST THAT YOGA AND WALKING AS MOVEMENT-BASED SELF-REGULATORY BEHAVIORAL TREATMENTS HAVE SOME DIFFERENTIAL EFFECTS BUT ARE BOTH BENEFICIAL FOR IBS PATIENTS, THOUGH MAINTENANCE OF A SELF-REGULATED WALKING PROGRAM MAY BE MORE FEASIBLE AND THEREFORE MORE EFFECTIVE LONG TERM. 2016 17 258 40 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 18 162 48 A RANDOMISED CONTROLLED TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN: RESULTS OF A PILOT STUDY. OBJECTIVE: TO CONDUCT A PILOT TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN (LBP) TO INFORM THE FEASIBILITY AND PRACTICALITY OF CONDUCTING A FULL-SCALE TRIAL IN THE UK; AND TO ASSESS THE EFFICACY OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN. DESIGN: A PRAGMATIC RANDOMISED CONTROLLED TRIAL WAS UNDERTAKEN COMPARING YOGA TO USUAL CARE. PARTICIPANTS: TWENTY PARTICIPANTS WHO HAD PRESENTED TO THEIR GP WITH CHRONIC LOW BACK PAIN IN THE PREVIOUS 18 MONTHS WERE RECRUITED VIA GP RECORDS FROM ONE PRACTICE IN YORK, UK. INTERVENTIONS: TWENTY PATIENTS WERE RANDOMISED TO EITHER 12 WEEKLY 75-MIN SESSIONS OF SPECIALISED YOGA PLUS WRITTEN ADVICE, OR USUAL CARE PLUS WRITTEN ADVICE. ALLOCATION WAS 50/50. MAIN OUTCOME MEASURES: RECRUITMENT RATE, LEVELS OF INTERVENTION ATTENDANCE, AND LOSS TO FOLLOW-UP WERE THE MAIN NON-CLINICAL OUTCOMES. CHANGE AS MEASURED BY THE ROLAND AND MORRIS DISABILITY QUESTIONNAIRE WAS THE PRIMARY CLINICAL OUTCOME. CHANGES IN THE ABERDEEN BACK PAIN SCALE, SF-12, EQ-5D, AND PAIN SELF-EFFICACY WERE SECONDARY CLINICAL OUTCOMES. DATA WERE COLLECTED VIA POSTAL QUESTIONNAIRE AT BASELINE, 4 WEEKS, AND 12 WEEKS FOLLOW-UP. RESULTS: OF THE 286 PATIENTS IDENTIFIED FROM THE GP DATABASE, 52 (18%) CONSENTED AND RETURNED THE ELIGIBILITY QUESTIONNAIRE, OUT OF THESE 20 (6.9%) WERE ELIGIBLE AND RANDOMISED. THE TOTAL PERCENTAGE OF PATIENTS RANDOMISED FROM THE GP PRACTICE POPULATION WAS 0.28%. TEN PATIENTS WERE RANDOMISED TO YOGA, RECEIVING AN AVERAGE OF 1.7 SESSIONS (RANGE 0-5), AND 10 WERE RANDOMISED TO USUAL CARE. AT 12 WEEKS FOLLOW-UP DATA WAS RECEIVED FROM 60% OF PATIENTS IN THE YOGA GROUP AND 90% OF PATIENTS IN THE USUAL CARE GROUP (75% OVERALL). NO SIGNIFICANT DIFFERENCES WERE SEEN BETWEEN GROUPS IN CLINICAL OUTCOMES APART FROM ON THE ABERDEEN BACK PAIN SCALE AT FOUR WEEKS FOLLOW-UP WHERE THE YOGA GROUP REPORTED SIGNIFICANTLY LESS PAIN. CONCLUSION: THIS PILOT STUDY PROVIDED USEFUL DATA AND INFORMATION TO INFORM THE DESIGN AND DEVELOPMENT OF A FULL-SCALE TRIAL OF YOGA FOR CLBP IN THE UK. A KEY FINDING IS THE CALCULATION OF GP PRACTICE TOTAL LIST SIZE REQUIRED FOR PATIENT RECRUITMENT IN A FULL-SCALE TRIAL, AND THE NEED TO IMPLEMENT METHODS TO INCREASE CLASS ATTENDANCE. 2010 19 41 40 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 20 1240 44 FEASIBILITY OF A MINDFUL YOGA PROGRAM FOR WOMEN WITH METASTATIC BREAST CANCER: RESULTS OF A RANDOMIZED PILOT STUDY. PURPOSE: PATIENTS WITH METASTATIC BREAST CANCER (MBC) EXPERIENCE HIGH LEVELS OF SYMPTOMS. YOGA INTERVENTIONS HAVE SHOWN PROMISE FOR IMPROVING CANCER SYMPTOMS BUT HAVE RARELY BEEN TESTED IN PATIENTS WITH ADVANCED DISEASE. THIS STUDY EXAMINED THE ACCEPTABILITY OF A COMPREHENSIVE YOGA PROGRAM FOR MBC AND THE FEASIBILITY OF CONDUCTING A RANDOMIZED TRIAL TESTING THE INTERVENTION. METHODS: SIXTY-THREE WOMEN WITH MBC WERE RANDOMIZED WITH A 2:1 ALLOCATION TO YOGA OR A SUPPORT GROUP COMPARISON CONDITION. BOTH INTERVENTIONS INVOLVED EIGHT WEEKLY GROUP SESSIONS. FEASIBILITY WAS QUANTIFIED USING RATES OF ACCRUAL, ATTRITION, AND SESSION ATTENDANCE. ACCEPTABILITY WAS ASSESSED WITH A STANDARDIZED SELF-REPORT MEASURE. PAIN, FATIGUE, SLEEP QUALITY, PSYCHOLOGICAL DISTRESS, MINDFULNESS, AND FUNCTIONAL CAPACITY WERE ASSESSED AT BASELINE, POST-INTERVENTION, AND 3 AND 6 MONTHS POST-INTERVENTION. RESULTS: WE MET GOALS FOR ACCRUAL AND RETENTION, WITH 50% OF ELIGIBLE PATIENTS ENROLLED AND 87% OF RANDOMIZED PARTICIPANTS COMPLETING POST-INTERVENTION SURVEYS. SIXTY-FIVE PERCENT OF WOMEN IN THE YOGA CONDITION AND 90% IN THE SUPPORT GROUP ATTENDED >/= 4 SESSIONS. EIGHTY PERCENT OF PARTICIPANTS IN THE YOGA CONDITION AND 65% IN THE SUPPORT GROUP INDICATED THAT THEY WERE HIGHLY SATISFIED WITH THE INTERVENTION. FOLLOWING TREATMENT, WOMEN IN THE YOGA INTERVENTION HAD MODEST IMPROVEMENTS IN SOME OUTCOMES; HOWEVER, OVERALL SYMPTOM LEVELS WERE LOW FOR WOMEN IN BOTH CONDITIONS. CONCLUSIONS: FINDINGS SUGGEST THAT THE YOGA INTERVENTION CONTENT WAS HIGHLY ACCEPTABLE TO PATIENTS WITH MBC, BUT THAT THERE ARE CHALLENGES TO IMPLEMENTING AN INTERVENTION INVOLVING EIGHT GROUP-BASED IN-PERSON SESSIONS. ALTERNATIVE MODES OF DELIVERY MAY BE NECESSARY TO REACH PATIENTS MOST IN NEED OF INTERVENTION. 2019