1  945 164 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	
                                                                                                                                                                                                                                                                                                                                                                                                            
2  258  72 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	
                                                                   
3 1118  84 EFFICACY OF AN EIGHT-WEEK YOGA INTERVENTION ON SYMPTOMS OF RESTLESS LEGS SYNDROME (RLS): A PILOT STUDY. BACKGROUND: RESTLESS LEGS SYNDROME (RLS) IS A COMMON AND HIGHLY BURDENSOME SLEEP DISORDER. WHILE RELAXATION THERAPIES, INCLUDING YOGA, ARE OFTEN RECOMMENDED FOR RLS MANAGEMENT, RIGOROUS SUPPORTING RESEARCH IS SPARSE. THE GOAL OF THIS PRELIMINARY STUDY WAS TO ASSESS THE EFFECTS OF YOGA ON RLS SYMPTOMS AND RELATED OUTCOMES IN WOMEN WITH RLS. METHODS: PARTICIPANTS WERE 13 NONSMOKING WOMEN WITH MODERATE TO SEVERE RLS, WHO DID NOT HAVE DIABETES, SLEEP APNEA, OR OTHER SERIOUS CONCOMITANT CHRONIC CONDITIONS, AND WHO WERE NOT PREGNANT. THE INTERVENTION WAS A GENTLE, 8-WEEK IYENGAR YOGA PROGRAM. CORE OUTCOMES ASSESSED PRE- AND POST-TREATMENT WERE RLS SYMPTOMS AND SYMPTOM SEVERITY (INTERNATIONAL RLS SCALE [IRLS] AND RLS ORDINAL SCALE), SLEEP QUALITY (MEDICAL OUTCOMES STUDY SLEEP SCALE), MOOD (PROFILE OF MOOD STATES), AND PERCEIVED STRESS (PERCEIVED STRESS SCALE). PARTICIPANTS ALSO COMPLETED YOGA LOGS AND A BRIEF EXIT QUESTIONNAIRE REGARDING THEIR EXPERIENCE WITH THE STUDY. RESULTS: TEN (10) WOMEN, AGED 32-66 YEARS, COMPLETED THE STUDY. PARTICIPANTS ATTENDED AN AVERAGE 13.4+/-0.5 (OF 16 POSSIBLE) CLASSES, AND COMPLETED A MEAN OF 4.1+/-0.3 (OF 5 POSSIBLE) HOMEWORK SESSIONS/WEEK. AT FOLLOW-UP, PARTICIPANTS DEMONSTRATED STRIKING REDUCTIONS IN RLS SYMPTOMS AND SYMPTOM SEVERITY, WITH SYMPTOMS DECREASING TO MINIMAL/MILD IN ALL BUT 1 WOMAN AND NO PARTICIPANT SCORING IN THE SEVERE RANGE BY WEEK 8. EFFECT SIZES (COHEN'S D) WERE LARGE: 1.6 FOR IRLS TOTAL, AND 2.2 FOR RLS ORDINAL SCALE. IRLS SCORES DECLINED SIGNIFICANTLY WITH INCREASING MINUTES OF HOMEWORK PRACTICE PER SESSION (R=0.70, P=0.025) AND TOTAL HOMEWORK MINUTES (R=0.64, P<0.05), SUGGESTING A POSSIBLE DOSE-RESPONSE RELATION. PARTICIPANTS ALSO SHOWED SIGNIFICANT IMPROVEMENTS IN SLEEP, PERCEIVED STRESS, AND MOOD (ALL P'S</=0.02), WITH EFFECT SIZES RANGING FROM 1.0 TO 1.6. CONCLUSIONS: THESE PRELIMINARY FINDINGS SUGGEST THAT YOGA MAY BE EFFECTIVE IN ATTENUATING RLS SYMPTOMS AND SYMPTOM SEVERITY, REDUCING PERCEIVED STRESS, AND IMPROVING SLEEP AND MOOD IN WOMEN WITH RLS.	2013	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
4 2325  49 TREATMENT OF MAJOR DEPRESSIVE DISORDER WITH IYENGAR YOGA AND COHERENT BREATHING: A RANDOMIZED CONTROLLED DOSING STUDY. OBJECTIVES: THE AIMS OF THIS STUDY WERE TO ASSESS THE EFFECTS OF AN INTERVENTION OF IYENGAR YOGA AND COHERENT BREATHING AT FIVE BREATHS PER MINUTE ON DEPRESSIVE SYMPTOMS AND TO DETERMINE OPTIMAL INTERVENTION YOGA DOSING FOR FUTURE STUDIES IN INDIVIDUALS WITH MAJOR DEPRESSIVE DISORDER (MDD). METHODS: SUBJECTS WERE RANDOMIZED TO THE HIGH-DOSE GROUP (HDG) OR LOW-DOSE GROUP (LDG) FOR A 12-WEEK INTERVENTION OF THREE OR TWO INTERVENTION CLASSES PER WEEK, RESPECTIVELY. ELIGIBLE SUBJECTS WERE 18-64 YEARS OLD WITH MDD, HAD BASELINE BECK DEPRESSION INVENTORY-II (BDI-II) SCORES >/=14, AND WERE EITHER ON NO ANTIDEPRESSANT MEDICATIONS OR ON A STABLE DOSE OF ANTIDEPRESSANTS FOR >/=3 MONTHS. THE INTERVENTION INCLUDED 90-MIN CLASSES PLUS HOMEWORK. OUTCOME MEASURES WERE BDI-II SCORES AND INTERVENTION COMPLIANCE. RESULTS: FIFTEEN HDG (MAGE = 38.4 +/- 15.1 YEARS) AND 15 LDG (MAGE = 34.7 +/- 10.4 YEARS) SUBJECTS COMPLETED THE INTERVENTION. BDI-II SCORES AT SCREENING AND COMPLIANCE DID NOT DIFFER BETWEEN GROUPS (P = 0.26). BDI-II SCORES DECLINED SIGNIFICANTLY FROM SCREENING (24.6 +/- 1.7) TO WEEK 12 (6.0 +/- 3.8) FOR THE HDG (-18.6 +/- 6.6; P < 0.001), AND FROM SCREENING (27.7 +/- 2.1) TO WEEK 12 (10.1 +/- 7.9) IN THE LDG (-17.7 +/- 9.3; P < 0.001). THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN GROUPS, BASED ON RESPONSE (I.E., >50% DECREASE IN BDI-II SCORES; P = 0.65) FOR THE HDG (13/15 SUBJECTS) AND LDG (11/15 SUBJECTS) OR REMISSION (I.E., NUMBER OF SUBJECTS WITH BDI-II SCORES <14; P = 1.00) FOR THE HDG (14/15 SUBJECTS) AND LDG (13/15 SUBJECTS) AFTER THE 12-WEEK INTERVENTION, ALTHOUGH A GREATER NUMBER OF SUBJECTS IN THE HDG HAD 12-WEEK BDI-II SCORES </=10 (P = 0.04). CONCLUSION: DURING THIS 12-WEEK INTERVENTION OF YOGA PLUS COHERENT BREATHING, DEPRESSIVE SYMPTOMS DECLINED SIGNIFICANTLY IN PATIENTS WITH MDD IN BOTH THE HDG AND LDG. BOTH GROUPS SHOWED COMPARABLE COMPLIANCE AND CLINICAL IMPROVEMENTS, WITH MORE SUBJECTS IN THE HDG EXHIBITING BDI-II SCORES </=10 AT WEEK 12.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
5  312  75 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	
                                                                                                                                                                                                                                                                                                                                                       
6  168  44 A RANDOMIZED CONTROLLED DOSING STUDY OF IYENGAR YOGA AND COHERENT BREATHING FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER: IMPACT ON SUICIDAL IDEATION AND SAFETY FINDINGS. BACKGROUND: YOGA INTERVENTIONS OFFER PROMISE FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD), YET THEIR SAFETY AND POTENTIAL IMPACT ON SUICIDAL IDEATION (SI) HAVE NOT BEEN WELL DOCUMENTED. THIS STUDY EVALUATED THE SAFETY OF A RANDOMIZED CONTROLLED DOSE-FINDING TRIAL OF IYENGAR YOGA PLUS COHERENT BREATHING FOR INDIVIDUALS WITH MDD, AS WELL AS THE POTENTIAL EFFECTS OF THE INTERVENTION ON SI WITHOUT INTENT. METHODS: PARTICIPANTS WITH BECK DEPRESSION INVENTORY-II (BDI-II) SCORES >/=14 AND A DIAGNOSIS OF MDD (USING DSM-IV CRITERIA) WERE RANDOMIZED TO EITHER A LOW DOSE GROUP (LDG) OR HIGH DOSE GROUP (HDG) AND RECEIVED A 12-WEEK MANUALIZED INTERVENTION. THE LDG INCLUDED TWO 90-MIN YOGA CLASSES PLUS THREE 30-MIN HOMEWORK SESSIONS WEEKLY. THE HDG OFFERED THREE 90-MIN CLASSES PLUS FOUR 30-MIN HOMEWORK SESSIONS WEEKLY. RESULTS: THIRTY-TWO INDIVIDUALS WITH MDD WERE RANDOMIZED, OF WHICH 30 COMPLETED THE PROTOCOL. AT SCREENING, SI WITHOUT INTENT WAS ENDORSED ON THE BDI-II BY 9 PARTICIPANTS; AFTER COMPLETING THE INTERVENTION, 8 OUT OF 9 REPORTED RESOLUTION OF SI. THERE WERE 17 ADVERSE EVENTS POSSIBLY-RELATED AND 15 DEFINITELY-RELATED TO THE INTERVENTION. THE MOST COMMON PROTOCOL-RELATED ADVERSE EVENT WAS MUSCULOSKELETAL PAIN, WHICH RESOLVED OVER THE COURSE OF THE STUDY. CONCLUSIONS: THE IYENGAR YOGA PLUS COHERENT BREATHING INTERVENTION WAS ASSOCIATED WITH THE RESOLUTION OF SI IN 8 OUT OF 9 PARTICIPANTS, WITH MILD SIDE EFFECTS THAT WERE PRIMARILY MUSCULOSKELETAL IN NATURE. THIS PRELIMINARY EVIDENCE SUGGESTS THAT THIS INTERVENTION MAY REDUCE SI WITHOUT INTENT AND BE SAFE FOR USE IN THOSE WITH MDD.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
7 1831  53 PSYCHOLOGICAL FUNCTION, IYENGAR YOGA, AND COHERENT BREATHING: A RANDOMIZED CONTROLLED DOSING STUDY. BACKGROUND: EVIDENCE SUGGESTS THAT YOGA MAY BE AN EFFECTIVE TREATMENT FOR MAJOR DEPRESSIVE DISORDER (MDD). STUDIES EVALUATING THE "DOSING" OF YOGA TREATMENT AND EFFICACY FOR MDD ARE NEEDED. THE GOAL OF THIS STUDY WAS TO ASSESS THE EFFECTS OF AN INTERVENTION COMBINING IYENGAR YOGA AND COHERENT BREATHING IN PARTICIPANTS WITH MDD AND DETERMINE THE OPTIMAL INTERVENTION DOSE. METHODS: THIRTY-TWO PARTICIPANTS (18 TO 65 Y OF AGE) DIAGNOSED WITH MDD WERE RANDOMIZED TO A HIGH-DOSE GROUP (HDG) OR A LOW-DOSE GROUP (LDG) OF YOGA AND COHERENT BREATHING FOR 12 WEEKS. THE HDG (N=15) INVOLVED THREE 90-MINUTE YOGA CLASSES AND FOUR 30-MINUTE HOMEWORK SESSIONS PER WEEK. THE LDG (N=15) INVOLVED TWO 90-MINUTE YOGA CLASSES AND THREE 30-MINUTE HOMEWORK SESSIONS PER WEEK. PARTICIPANTS WERE EVALUATED AT BASELINE, WEEK 4, WEEK 8, AND WEEK 12 WITH THE FOLLOWING INSTRUMENTS: POSITIVITY SELF-TEST, SPIELBERGER STATE ANXIETY INVENTORY, PATIENT HEALTH QUESTIONNAIRE-9, PITTSBURGH SLEEP QUALITY INDEX, AND EXERCISE-INDUCED FEELING INVENTORY. DATA WERE ANALYZED USING INTENT-TO-TREAT METHODS. RESULTS: SIGNIFICANT IMPROVEMENTS IN ALL OUTCOME MEASURES WERE FOUND FOR BOTH GROUPS, WITH ACUTE AND CUMULATIVE BENEFITS. ALTHOUGH THE HDG SHOWED GREATER IMPROVEMENTS ON ALL SCALES, BETWEEN-GROUP DIFFERENCES DID NOT REACH SIGNIFICANCE, POSSIBLY DUE TO LACK OF POWER BECAUSE OF THE SMALL SAMPLE SIZE. CUMULATIVE YOGA MINUTES WERE CORRELATED WITH IMPROVEMENT IN OUTCOME MEASURES. LIMITATION: THIS DOSING STUDY DID NOT INCLUDE A NON-YOGA CONTROL. CONCLUSIONS: IMPROVEMENT IN PSYCHOLOGICAL SYMPTOMS CORRELATED WITH CUMULATIVE YOGA PRACTICE. BOTH INTERVENTIONS REDUCED SYMPTOMS OF DEPRESSION AND ANXIETY AND INCREASED FEELINGS OF POSITIVITY. THE TIME COMMITMENT FOR YOGA PRACTICE NEEDS TO BE WEIGHED AGAINST BENEFITS WHEN DESIGNING YOGA INTERVENTIONS.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
8 2132  54 THE EFFECTS OF A GENTLE YOGA PROGRAM ON SLEEP, MOOD, AND BLOOD PRESSURE IN OLDER WOMEN WITH RESTLESS LEGS SYNDROME (RLS): A PRELIMINARY RANDOMIZED CONTROLLED TRIAL. OBJECTIVE. TO EXAMINE THE EFFECTS OF YOGA VERSUS AN EDUCATIONAL FILM PROGRAM ON SLEEP, MOOD, PERCEIVED STRESS, AND SYMPATHETIC ACTIVATION IN OLDER WOMEN WITH RLS. METHODS. PARTICIPANTS WERE DRAWN FROM A LARGER TRIAL REGARDING THE EFFECTS OF YOGA ON CARDIOVASCULAR DISEASE RISK PROFILES IN OVERWEIGHT, SEDENTARY POSTMENOPAUSAL WOMEN. SEVENTY-FIVE WOMEN WERE RANDOMIZED TO RECEIVE EITHER AN 8-WEEK YOGA (N = 38) OR EDUCATIONAL FILM (N = 37) PROGRAM. ALL 75 PARTICIPANTS COMPLETED AN RLS SCREENING QUESTIONNAIRE. THE 20 WOMEN WHO MET ALL FOUR DIAGNOSTIC CRITERIA FOR RLS (N = 10 YOGA, 10 FILM GROUP) COMPRISED THE POPULATION FOR THIS NESTED STUDY. MAIN OUTCOMES ASSESSED PRE- AND POST-TREATMENT INCLUDED: SLEEP (PITTSBURGH SLEEP QUALITY INDEX), STRESS (PERCEIVED STRESS SCALE), MOOD (PROFILE OF MOOD STATES, STATE-TRAIT ANXIETY INVENTORY), BLOOD PRESSURE, AND HEART RATE. RESULTS. THE YOGA GROUP DEMONSTRATED SIGNIFICANTLY GREATER IMPROVEMENTS THAN CONTROLS IN MULTIPLE DOMAINS OF SLEEP QUALITY AND MOOD, AND SIGNIFICANTLY GREATER REDUCTIONS IN INSOMNIA PREVALENCE, ANXIETY, PERCEIVED STRESS, AND BLOOD PRESSURE (ALL P'S</=0.05). ADJUSTED INTERGROUP EFFECT SIZES FOR PSYCHOSOCIAL VARIABLES WERE LARGE, RANGING FROM 1.9 FOR STATE ANXIETY TO 2.6 FOR SLEEP QUALITY. CONCLUSIONS. THESE PRELIMINARY FINDINGS SUGGEST YOGA MAY OFFER AN EFFECTIVE INTERVENTION FOR IMPROVING SLEEP, MOOD, PERCEIVED STRESS, AND BLOOD PRESSURE IN OLDER WOMEN WITH RLS.	2012	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
9 1140  54 EFFICACY OF YOGA VS COGNITIVE BEHAVIORAL THERAPY VS STRESS EDUCATION FOR THE TREATMENT OF GENERALIZED ANXIETY DISORDER: A RANDOMIZED CLINICAL TRIAL. IMPORTANCE: GENERALIZED ANXIETY DISORDER (GAD) IS COMMON, IMPAIRING, AND UNDERTREATED. ALTHOUGH MANY PATIENTS WITH GAD SEEK COMPLEMENTARY AND ALTERNATIVE INTERVENTIONS, INCLUDING YOGA, DATA SUPPORTING YOGA'S EFFICACY OR HOW IT COMPARES TO FIRST-LINE TREATMENTS ARE LACKING. OBJECTIVES: TO ASSESS WHETHER YOGA (KUNDALINI YOGA) AND COGNITIVE BEHAVIORAL THERAPY (CBT) FOR GAD ARE EACH MORE EFFECTIVE THAN A CONTROL CONDITION (STRESS EDUCATION) AND WHETHER YOGA IS NONINFERIOR TO CBT FOR THE TREATMENT OF GAD. DESIGN, SETTING, AND PARTICIPANTS: FOR THIS RANDOMIZED, 3-ARM, CONTROLLED, SINGLE-BLIND (MASKED INDEPENDENT RATERS) CLINICAL TRIAL, PARTICIPANTS WERE RECRUITED FROM 2 SPECIALTY ACADEMIC CENTERS STARTING DECEMBER 1, 2013, WITH ASSESSMENT ENDING OCTOBER 25, 2019. PRIMARY ANALYSES, COMPLETED BY FEBRUARY 12, 2020, INCLUDED SUPERIORITY TESTING OF KUNDALINI YOGA AND CBT VS STRESS EDUCATION AND NONINFERIORITY TESTING OF KUNDALINI YOGA VS CBT. INTERVENTIONS: PARTICIPANTS WERE RANDOMIZED TO KUNDALINI YOGA (N = 93), CBT FOR GAD (N = 90), OR STRESS EDUCATION (N = 43), WHICH WERE EACH DELIVERED TO GROUPS OF 4 TO 6 PARTICIPANTS BY 2 INSTRUCTORS DURING TWELVE 120-MINUTE SESSIONS WITH 20 MINUTES OF DAILY HOMEWORK. MAIN OUTCOMES AND MEASURES: THE PRIMARY INTENTION-TO-TREAT OUTCOME WAS ACUTE GAD RESPONSE (CLINICAL GLOBAL IMPRESSION-IMPROVEMENT SCALE SCORE OF MUCH OR VERY MUCH IMPROVED) AFTER 12 WEEKS AS ASSESSED BY TRAINED INDEPENDENT RATERS. RESULTS: OF 538 PARTICIPANTS WHO PROVIDED CONSENT AND WERE EVALUATED, 226 (MEAN [SD] AGE, 33.4 [13.5] YEARS; 158 [69.9%] FEMALE) WITH A PRIMARY DIAGNOSIS OF GAD WERE INCLUDED IN THE TRIAL. A TOTAL OF 155 PARTICIPANTS (68.6%) COMPLETED THE POSTTREATMENT ASSESSMENT. COMPLETION RATES DID NOT DIFFER (KUNDALINI YOGA, 60 [64.5%]; CBT, 67 [74.4%]; AND STRESS EDUCATION, 28 [65.1%]: CHI2 = 2.39, DF = 2, P = .30). RESPONSE RATES WERE HIGHER IN THE KUNDALINI YOGA GROUP (54.2%) THAN IN THE STRESS EDUCATION GROUP (33.%) (ODDS RATIO [OR], 2.46 [95% CI, 1.12-5.42]; P = .03; NUMBER NEEDED TO TREAT, 4.59 [95% CI, 2.52-46.19]) AND IN THE CBT GROUP (70.8%) COMPARED WITH THE STRESS EDUCATION GROUP (33.0%) (OR, 5.00 [95% CI, 2.12-11.82]; P < .001; NUMBER NEEDED TO TREAT, 2.62 [95% CI, 1.91-5.68]). HOWEVER, THE NONINFERIORITY TEST DID NOT FIND KUNDALINI YOGA TO BE AS EFFECTIVE AS CBT (DIFFERENCE, 16.6%; P = .42 FOR NONINFERIORITY). CONCLUSIONS AND RELEVANCE: IN THIS TRIAL, KUNDALINI YOGA WAS EFFICACIOUS FOR GAD, BUT THE RESULTS SUPPORT CBT REMAINING FIRST-LINE TREATMENT. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT01912287.	2021	

10  518  48 COMPARING ONCE- VERSUS TWICE-WEEKLY YOGA CLASSES FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY LOW INCOME MINORITIES: A RANDOMIZED DOSING TRIAL. BACKGROUND. PREVIOUS STUDIES HAVE DEMONSTRATED THAT ONCE-WEEKLY YOGA CLASSES ARE EFFECTIVE FOR CHRONIC LOW BACK PAIN (CLBP) IN WHITE ADULTS WITH HIGH SOCIOECONOMIC STATUS. THE COMPARATIVE EFFECTIVENESS OF TWICE-WEEKLY CLASSES AND GENERALIZABILITY TO RACIALLY DIVERSE LOW INCOME POPULATIONS ARE UNKNOWN. METHODS. WE CONDUCTED A 12-WEEK RANDOMIZED, PARALLEL-GROUP, DOSING TRIAL FOR 95 ADULTS RECRUITED FROM AN URBAN SAFETY-NET HOSPITAL AND FIVE COMMUNITY HEALTH CENTERS COMPARING ONCE-WEEKLY (N = 49) VERSUS TWICE-WEEKLY (N = 46) STANDARDIZED YOGA CLASSES SUPPLEMENTED BY HOME PRACTICE. PRIMARY OUTCOMES WERE CHANGE FROM BASELINE TO 12 WEEKS IN PAIN (11-POINT SCALE) AND BACK-RELATED FUNCTION (23-POINT MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE). RESULTS. 82% OF PARTICIPANTS WERE NONWHITE; 77% HAD ANNUAL HOUSEHOLD INCOMES <$40,000. THE SAMPLE'S BASELINE MEAN PAIN INTENSITY [6.9 (SD 1.6)] AND FUNCTION [13.7 (SD 5.0)] REFLECTED MODERATE TO SEVERE BACK PAIN AND IMPAIRMENT. PAIN AND BACK-RELATED FUNCTION IMPROVED WITHIN BOTH GROUPS (P < 0.001). HOWEVER, THERE WERE NO DIFFERENCES BETWEEN ONCE-WEEKLY AND TWICE-WEEKLY GROUPS FOR PAIN REDUCTION [-2.1 (95% CI -2.9, -1.3) VERSUS -2.4 (95% CI -3.1, -1.8), P = 0.62] OR BACK-RELATED FUNCTION [-5.1 (95% CI -7.0, -3.2) VERSUS -4.9 (95% CI -6.5, -3.3), P = 0.83]. CONCLUSIONS. TWELVE WEEKS OF ONCE-WEEKLY OR TWICE-WEEKLY YOGA CLASSES WERE SIMILARLY EFFECTIVE FOR PREDOMINANTLY LOW INCOME MINORITY ADULTS WITH MODERATE TO SEVERE CHRONIC LOW BACK PAIN. THIS TRIAL IS REGISTERED WITH CLINICALTRIALS.GOV NCT01761617.	2013	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
11   70  42 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
12  767  51 EFFECT OF TRADITIONAL YOGA, MINDFULNESS-BASED COGNITIVE THERAPY, AND COGNITIVE BEHAVIORAL THERAPY, ON HEALTH RELATED QUALITY OF LIFE: A RANDOMIZED CONTROLLED TRIAL ON PATIENTS ON SICK LEAVE BECAUSE OF BURNOUT. BACKGROUND: TO EXPLORE IF HEALTH RELATED QUALITY OF LIFE(HRQOL) INCREASED AFTER TRADITIONAL YOGA(TY), MINDFULNESS BASED COGNITIVE THERAPY(MBCT), OR COGNITIVE BEHAVIORAL THERAPY(CBT), IN PATIENTS ON SICK LEAVE BECAUSE OF BURNOUT. METHODS: RANDOMIZED CONTROLLED TRIAL, BLINDED, IN NINETY-FOUR PRIMARY HEALTH CARE PATIENTS, BLOCK RANDOMIZED TO TY, MBCT OR CBT (ACTIVE CONTROL) BETWEEN SEPTEMBER 2007 AND NOVEMBER 2009. PATIENTS WERE LIVING IN THE STOCKHOLM METROPOLITAN AREA, SWEDEN, WERE AGED 18-65 YEARS AND WERE ON 50%-100% SICK LEAVE. A GROUP TREATMENT FOR 20 WEEKS, THREE HOURS PER WEEK, WITH HOMEWORK FOUR HOURS PER WEEK. HRQOL WAS MEASURED BY THE SWED-QUAL QUESTIONNAIRE, COMPRISING 67 ITEMS GROUPED INTO 13 SUBSCALES, EACH WITH A SEPARATE INDEX, AND SCORES FROM 0 (WORSE) TO 100 (BEST). SWED-QUAL COVERS ASPECTS OF PHYSICAL AND EMOTIONAL WELL-BEING, COGNITIVE FUNCTION, SLEEP, GENERAL HEALTH AND SOCIAL AND SEXUAL FUNCTIONING. STATISTICS: WILCOXON'S RANK SUM AND WILCOXON'S SIGN RANK TESTS, BONETT-PRICE FOR MEDIANS AND CONFIDENCE INTERVALS, AND COHEN'S D. RESULTS: TWENTY-SIX PATIENTS IN THE TY (21 WOMEN), AND 27 PATIENTS IN BOTH THE MBCT (24 WOMEN) AND IN THE CBT (25 WOMEN), WERE ANALYZED. TEN SUBSCALES IN TY AND SEVEN SUBSCALES IN MBCT AND CBT SHOWED IMPROVEMENTS, P < 0.05, IN SEVERAL OF THE MAIN DOMAINS AFFECTED IN BURNOUT, E.G. EMOTIONAL WELL-BEING, PHYSICAL WELL-BEING, COGNITIVE FUNCTION AND SLEEP. THE MEDIAN IMPROVEMENT RANGED FROM 0 TO 27 POINTS IN TY, FROM 4 TO 25 POINTS IN CBT AND FROM 0 TO 25 POINTS IN MBCT. THE EFFECT SIZE WAS MAINLY MEDIUM OR LARGE. COMPARISON OF TREATMENTS SHOWED NO STATISTICAL DIFFERENCES, BUT BETTER EFFECT (SMALL) OF BOTH TY AND MBCT COMPARED TO CBT. WHEN COMPARING THE EFFECT OF TY AND MBCT, BOTH SHOWED A BETTER EFFECT (SMALL) IN TWO SUBSCALES EACH. CONCLUSIONS: A 20 WEEK GROUP TREATMENT WITH TY, CBT OR MBCT HAD EQUAL EFFECTS ON HRQOL, AND PARTICULARLY ON MAIN DOMAINS AFFECTED IN BURNOUT. THIS INDICATES THAT TY, MBCT AND CBT CAN BE USED AS BOTH TREATMENT AND PREVENTION, TO IMPROVE HRQOL IN PATIENTS ON SICK LEAVE BECAUSE OF BURNOUT, REDUCING THE RISK OF FUTURE MORBIDITY. TRIAL REGISTRATION: JULY 22, 2012, RETROSPECTIVELY REGISTERED. CLINICALTRAILS.GOV NCT01168661 . FUNDING: STOCKHOLM COUNTY COUNCIL, GRANT 2003-5.	2018	
                                                                                                                                                                                                                                                 
13  172  48 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
14 2323  57 TREATMENT OF CHRONIC PRIMARY SLEEP ONSET INSOMNIA WITH KUNDALINI YOGA: A RANDOMIZED CONTROLLED TRIAL WITH ACTIVE SLEEP HYGIENE COMPARISON. STUDY OBJECTIVES: PRIOR STUDIES HAVE SUGGESTED A BENEFIT OF YOGA FOR ALLEVIATING SLEEP DISTURBANCE; HOWEVER, MANY STUDIES HAVE HAD METHODOLOGICAL LIMITATIONS. THIS TRIAL STUDY AIMED TO EXTEND THAT LITERATURE BY INCLUDING AN ACTIVE SLEEP HYGIENE COMPARISON. METHODS: PARTICIPANTS AGED 25-59 YEARS WITH A PRIMARY COMPLAINT OF SLEEP ONSET INSOMNIA LASTING AT LEAST 6 MONTHS WERE BLOCK RANDOMIZED TO AN 8-WEEK KUNDALINI YOGA OR SLEEP HYGIENE INTERVENTION, BOTH CONSISTING OF INITIAL 60-MINUTE INSTRUCTION AND WEEKLY CHECK-INS. DAILY SLEEP DIARIES AND QUESTIONNAIRES WERE COLLECTED AT BASELINE, THROUGHOUT THE INTERVENTION, AND AT 6-MONTH FOLLOW-UP. DATA WERE ANALYZED USING LINEAR MIXED MODELS (N = 20 IN EACH GROUP). RESULTS: PARTICIPANT RATINGS OF THE INTERVENTIONS DID NOT SIGNIFICANTLY DIFFER. SLEEP HYGIENE IMPROVED SEVERAL DIARY AND QUESTIONNAIRE OUTCOMES, HOWEVER, YOGA RESULTED IN EVEN GREATER IMPROVEMENTS CORRESPONDING TO MEDIUM-TO-LARGE BETWEEN-GROUP EFFECT SIZES. TOTAL SLEEP TIME INCREASED PROGRESSIVELY ACROSS YOGA TREATMENT (D = 0.95, P = .002), CONCURRENT WITH INCREASED SLEEP EFFICIENCY (D = 1.36, P < .001) AND DECREASED SLEEP ONSET LATENCY (D = -1.16, P < .001), BUT WITHOUT CHANGES IN PRE-SLEEP AROUSAL (D =-0.30, P = .59). REMISSION RATES WERE ALSO HIGHER FOR YOGA COMPARED TO SLEEP HYGIENE, WITH >/= 80% OF YOGA PARTICIPANTS REPORTING AVERAGE SLEEP ONSET LATENCY < 30 MINUTES AND SLEEP EFFICIENCY > 80% AT 6-MONTH FOLLOW-UP. FOR OVER 50% OF YOGA PARTICIPANTS, THE INSOMNIA SEVERITY INDEX DECREASED BY AT LEAST 8 POINTS AT END OF TREATMENT AND FOLLOW-UP. CONCLUSIONS: YOGA, TAUGHT IN A SELF-CARE FRAMEWORK WITH MINIMAL INSTRUCTOR BURDEN, WAS ASSOCIATED WITH SELF-REPORTED IMPROVEMENTS ABOVE AND BEYOND AN ACTIVE SLEEP HYGIENE COMPARISON, SUSTAINED AT 6-MONTH FOLLOW-UP. FOLLOW-UP STUDIES ARE NEEDED TO ASSESS ACTIGRAPHY AND POLYSOMNOGRAPHY OUTCOMES, AS WELL AS POSSIBLE MECHANISMS OF CHANGE. CLINICAL TRIAL REGISTRATION: REGISTRY: CLINICALTRIALS.GOV; NAME: YOGA AS A TREATMENT FOR INSOMNIA; URL: HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT00033865; IDENTIFIER: NCT00033865. CITATION: KHALSA SBS, GOLDSTEIN MR. TREATMENT OF CHRONIC PRIMARY SLEEP ONSET INSOMNIA WITH KUNDALINI YOGA: A RANDOMIZED CONTROLLED TRIAL WITH ACTIVE SLEEP HYGIENE COMPARISON. J CLIN SLEEP MED. 2021;17(9):1841-1852.	2021	
                                                                                                                                                                                                                                                                                           
15 2318  52 TREATING MAJOR DEPRESSION WITH YOGA: A PROSPECTIVE, RANDOMIZED, CONTROLLED PILOT TRIAL. BACKGROUND: CONVENTIONAL PHARMACOTHERAPIES AND PSYCHOTHERAPIES FOR MAJOR DEPRESSION ARE ASSOCIATED WITH LIMITED ADHERENCE TO CARE AND RELATIVELY LOW REMISSION RATES. YOGA MAY OFFER AN ALTERNATIVE TREATMENT OPTION, BUT RIGOROUS STUDIES ARE FEW. THIS RANDOMIZED CONTROLLED TRIAL WITH BLINDED OUTCOME ASSESSORS EXAMINED AN 8-WEEK HATHA YOGA INTERVENTION AS MONO-THERAPY FOR MILD-TO-MODERATE MAJOR DEPRESSION. METHODS: INVESTIGATORS RECRUITED 38 ADULTS IN SAN FRANCISCO MEETING CRITERIA FOR MAJOR DEPRESSION OF MILD-TO-MODERATE SEVERITY, PER STRUCTURED PSYCHIATRIC INTERVIEW AND SCORES OF 14-28 ON BECK DEPRESSION INVENTORY-II (BDI). AT SCREENING, INDIVIDUALS ENGAGED IN PSYCHOTHERAPY, ANTIDEPRESSANT PHARMACOTHERAPY, HERBAL OR NUTRACEUTICAL MOOD THERAPIES, OR MIND-BODY PRACTICES WERE EXCLUDED. PARTICIPANTS WERE 68% FEMALE, WITH MEAN AGE 43.4 YEARS (SD = 14.8, RANGE = 22-72), AND MEAN BDI SCORE 22.4 (SD = 4.5). TWENTY PARTICIPANTS WERE RANDOMIZED TO 90-MINUTE HATHA YOGA PRACTICE GROUPS TWICE WEEKLY FOR 8 WEEKS. EIGHTEEN PARTICIPANTS WERE RANDOMIZED TO 90-MINUTE ATTENTION CONTROL EDUCATION GROUPS TWICE WEEKLY FOR 8 WEEKS. CERTIFIED YOGA INSTRUCTORS DELIVERED BOTH INTERVENTIONS AT A UNIVERSITY CLINIC. PRIMARY OUTCOME WAS DEPRESSION SEVERITY, MEASURED BY BDI SCORES EVERY 2 WEEKS FROM BASELINE TO 8 WEEKS. SECONDARY OUTCOMES WERE SELF-EFFICACY AND SELF-ESTEEM, MEASURED BY SCORES ON THE GENERAL SELF-EFFICACY SCALE (GSES) AND ROSENBERG SELF-ESTEEM SCALE (RSES) AT BASELINE AND AT 8 WEEKS. RESULTS: IN INTENT-TO-TREAT ANALYSIS, YOGA PARTICIPANTS EXHIBITED SIGNIFICANTLY GREATER 8-WEEK DECLINE IN BDI SCORES THAN CONTROLS (P-VALUE = 0.034). IN SUB-ANALYSES OF PARTICIPANTS COMPLETING FINAL 8-WEEK MEASURES, YOGA PARTICIPANTS WERE MORE LIKELY TO ACHIEVE REMISSION, DEFINED PER FINAL BDI SCORE </= 9 (P-VALUE = 0.018). EFFECT SIZE OF YOGA IN REDUCING BDI SCORES WAS LARGE, PER COHEN'S D = -0.96 [95%CI, -1.81 TO -0.12]. INTERVENTION GROUPS DID NOT DIFFER SIGNIFICANTLY IN 8-WEEK CHANGE SCORES FOR EITHER THE GSES OR RSES. CONCLUSION: IN ADULTS WITH MILD-TO-MODERATE MAJOR DEPRESSION, AN 8-WEEK HATHA YOGA INTERVENTION RESULTED IN STATISTICALLY AND CLINICALLY SIGNIFICANT REDUCTIONS IN DEPRESSION SEVERITY. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT01210651.	2017	
                                                                                                                                                                                                                                                                                                                                                                                           
16  176  43 A RANDOMIZED CONTROLLED TRIAL OF KUNDALINI YOGA IN MILD COGNITIVE IMPAIRMENT. BACKGROUND: GLOBAL POPULATION AGING WILL RESULT IN INCREASING RATES OF COGNITIVE DECLINE AND DEMENTIA. THUS, EFFECTIVE, LOW-COST, AND LOW SIDE-EFFECT INTERVENTIONS FOR THE TREATMENT AND PREVENTION OF COGNITIVE DECLINE ARE URGENTLY NEEDED. OUR STUDY IS THE FIRST TO INVESTIGATE THE EFFECTS OF KUNDALINI YOGA (KY) TRAINING ON MILD COGNITIVE IMPAIRMENT (MCI). METHODS: OLDER PARTICIPANTS (>/=55 YEARS OF AGE) WITH MCI WERE RANDOMIZED TO EITHER A 12-WEEK KY INTERVENTION OR MEMORY ENHANCEMENT TRAINING (MET; GOLD-STANDARD, ACTIVE CONTROL). COGNITIVE (I.E. MEMORY AND EXECUTIVE FUNCTIONING) AND MOOD (I.E. DEPRESSION, APATHY, AND RESILIENCE) ASSESSMENTS WERE ADMINISTERED AT BASELINE, 12 WEEKS AND 24 WEEKS. RESULTS: AT BASELINE, 81 PARTICIPANTS HAD NO SIGNIFICANT BASELINE GROUP DIFFERENCES IN CLINICAL OR DEMOGRAPHIC CHARACTERISTICS. AT 12 WEEKS AND 24 WEEKS, BOTH KY AND MET GROUPS SHOWED SIGNIFICANT IMPROVEMENT IN MEMORY; HOWEVER, ONLY KY SHOWED SIGNIFICANT IMPROVEMENT IN EXECUTIVE FUNCTIONING. ONLY THE KY GROUP SHOWED SIGNIFICANT IMPROVEMENT IN DEPRESSIVE SYMPTOMS AND RESILIENCE AT WEEK 12. CONCLUSION: KY GROUP SHOWED SHORT- AND LONG-TERM IMPROVEMENTS IN EXECUTIVE FUNCTIONING AS COMPARED TO MET, AND BROADER EFFECTS ON DEPRESSED MOOD AND RESILIENCE. THIS OBSERVATION SHOULD BE CONFIRMED IN FUTURE CLINICAL TRIALS OF YOGA INTERVENTION FOR TREATMENT AND PREVENTION OF COGNITIVE DECLINE (NCT01983930).	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
17 1787  42 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	
                                                    
18 2852  49 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	
                                                                                                                                                                                                                                                                                                                                                                                    
19   41  47 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  345  43 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