1 1544 205 KUNDALINI YOGA MEDITATION VERSUS THE RELAXATION RESPONSE MEDITATION FOR TREATING ADULTS WITH OBSESSIVE-COMPULSIVE DISORDER: A RANDOMIZED CLINICAL TRIAL. BACKGROUND: OBSESSIVE-COMPULSIVE DISORDER (OCD) IS OFTEN A LIFE-LONG DISORDER WITH HIGH PSYCHOSOCIAL IMPAIRMENT. SEROTONIN REUPTAKE INHIBITORS (SRIS) ARE THE ONLY FDA APPROVED DRUGS, AND APPROXIMATELY 50% OF PATIENTS ARE NON-RESPONDERS WHEN USING A CRITERION OF 25% TO 35% IMPROVEMENT WITH THE YALE-BROWN OBSESSIVE-COMPULSIVE SCALE (Y-BOCS). ABOUT 30% ARE NON-RESPONDERS TO COMBINED FIRST-LINE THERAPIES (SRIS AND EXPOSURE AND RESPONSE PREVENTION). PREVIOUS RESEARCH (ONE OPEN, ONE RANDOMIZED CLINICAL TRIAL) HAS DEMONSTRATED THAT KUNDALINI YOGA (KY) MEDITATION CAN LEAD TO AN IMPROVEMENT IN SYMPTOMS OF OBSESSIVE-COMPULSIVE SEVERITY. WE EXPAND HERE WITH A LARGER TRIAL. DESIGN: THIS TRIAL COMPARED TWO PARALLEL RUN GROUPS [KY VS. RELAXATION RESPONSE MEDITATION (RR)]. PATIENTS WERE RANDOMLY ALLOCATED BASED ON GENDER AND Y-BOCS SCORES. THEY WERE TOLD TWO DIFFERENT (UNNAMED) TYPES OF MEDITATION WOULD BE COMPARED, AND INFORMED IF ONE SHOWED GREATER BENEFITS, THE GROUPS WOULD MERGE FOR 12 MONTHS USING THE MORE EFFECTIVE INTERVENTION. RATERS WERE BLIND IN PHASE ONE (0-4.5 MONTHS) TO PATIENT ASSIGNMENTS, BUT NOT IN PHASE TWO. MAIN OUTCOME MEASURES: PRIMARY OUTCOME VARIABLE, CLINICIAN-ADMINISTERED Y-BOCS. SECONDARY SCALES: DIMENSIONAL YALE-BROWN OBSESSIVE COMPULSIVE SCALE (CLINICIAN-ADMINISTERED), PROFILE OF MOOD SCALES, BECK ANXIETY INVENTORY, BECK DEPRESSION INVENTORY, CLINICAL GLOBAL IMPRESSION, SHORT FORM 36 HEALTH SURVEY. RESULTS: PHASE ONE: BASELINE Y-BOCS SCORES: KY MEAN = 26.46 (SD 5.124; N = 24), RR MEAN = 26.79 (SD = 4.578; N = 24). AN INTENT-TO-TREAT ANALYSIS WITH THE LAST OBSERVATION CARRIED FORWARD FOR DROPOUTS SHOWED STATISTICALLY GREATER IMPROVEMENT WITH KY COMPARED TO RR ON THE Y-BOCS, AND STATISTICALLY GREATER IMPROVEMENT ON FIVE OF SIX SECONDARY MEASURES. FOR COMPLETERS, THE Y-BOCS SHOWED 40.4% IMPROVEMENT FOR KY (N = 16), 17.9% FOR RR (N = 11); 31.3% IN KY WERE JUDGED TO BE IN REMISSION COMPARED TO 9.1% IN RR. KY COMPLETERS SHOWED GREATER IMPROVEMENT ON FIVE OF SIX SECONDARY MEASURES. AT THE END OF PHASE TWO (12 MONTHS), PATIENTS, DRAWN FROM THE INITIAL GROUPS, WHO ELECTED TO RECEIVE KY CONTINUED TO SHOW IMPROVEMENT IN THEIR Y-BOCS SCORES. CONCLUSION: KY SHOWS PROMISE AS AN ADD-ON OPTION FOR OCD PATIENTS UNRESPONSIVE TO FIRST LINE THERAPIES. FUTURE STUDIES WILL ESTABLISH KY'S RELATIVE EFFICACY COMPARED TO EXPOSURE AND RESPONSE PREVENTION AND/OR MEDICATIONS, AND THE MOST EFFECTIVE TREATMENT SCHEDULE. CLINICAL TRIAL REGISTRATION: WWW.CLINICALTRIALS.GOV, IDENTIFIER NCT01833442.	2019	
                                                   
2   99  43 A PATIENT WITH ELECTROCONVULSIVE THERAPY-RESISTANT MAJOR DEPRESSIVE DISORDER WITH A FULL RESPONSE TO HEATED YOGA: A CASE REPORT. DEPRESSION REMAINS DIFFICULT TO TREAT AS A RESULT OF LESS THAN OPTIMAL EFFICACY AND TROUBLESOME SIDE EFFECTS OF ANTIDEPRESSANTS. THE AUTHORS PRESENT THE CASE OF A PATIENT WITH TREATMENT-RESISTANT DEPRESSION WITH MELANCHOLIC FEATURES WHO HAD PREVIOUSLY BEEN UNRESPONSIVE TO ELECTROCONVULSIVE THERAPY (ECT) PLUS AN ANTIDEPRESSANT REGIMEN BUT WHOSE CONDITION FULLY REMITTED WITH THE ADDITION OF A STANDARDIZED FORM OF HEATED HATHA YOGA (HY; BIKRAM YOGA) PRACTICED IN A ROOM HEATED TO 105 DEGREES F. THE PATIENT WAS A 28-YEAR-OLD WOMAN WHO UNDERWENT 8 WEEKS OF HY AS PART OF A RANDOMIZED CONTROLLED TRIAL OF HY FOR DEPRESSION WHILE CONTINUING HER ANTIDEPRESSANT TREATMENT. THE PATIENT WAS ASKED TO ATTEND A MINIMUM OF 2 WEEKLY, 90-MINUTE HY CLASSES. AFTER 8 WEEKS (12 CLASSES IN TOTAL), THE PATIENT NO LONGER MET THE CRITERIA FOR A MAJOR DEPRESSIVE EPISODE WITH MELANCHOLIC FEATURES, PER MINI-INTERNATIONAL NEUROPSYCHIATRIC INTERVIEW (MINI) CRITERIA. HER DEPRESSIVE SYMPTOMS HAD IMPROVED DRAMATICALLY, WITH INVENTORY OF DEPRESSIVE SYMPTOMATOLOGY, CLINICIAN-RATED (IDS-C30), AND HAMILTON DEPRESSION RATING SCALE (HAM-D28) SCORES DECREASING FROM 28 AT BASELINE TO 3, AND FROM 28 AT BASELINE TO 4, RESPECTIVELY, INDICATING REMISSION. THIS PATIENT'S ECT-RESISTANT DEPRESSION REMITTED WITH THE ADDITION OF HY TO HER ANTIDEPRESSANT REGIMEN. BECAUSE OF HER YOUTH AND ATHLETICISM, THIS PATIENT WAS LIKELY WELL SUITED TO THIS RIGOROUS FORM OF YOGA. FURTHER RESEARCH IS NEEDED TO EXPLORE HY AS A POTENTIAL INTERVENTION FOR TREATMENT-RESISTANT DEPRESSION.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
3  327  49 ANTIDEPRESSANT EFFICACY OF SUDARSHAN KRIYA YOGA (SKY) IN MELANCHOLIA: A RANDOMIZED COMPARISON WITH ELECTROCONVULSIVE THERAPY (ECT) AND IMIPRAMINE. BACKGROUND: SUDARSHAN KRIYA YOGA (SKY) IS A PROCEDURE THAT INVOLVES ESSENTIALLY RHYTHMIC HYPERVENTILATION AT DIFFERENT RATES OF BREATHING. THE ANTIDEPRESSANT EFFICACY OF SKY WAS DEMONSTRATED IN DYSTHYMIA IN A PROSPECTIVE, OPEN CLINICAL TRIAL. THIS STUDY COMPARED THE RELATIVE ANTIDEPRESSANT EFFICACY OF SKY IN MELANCHOLIA WITH TWO OF THE CURRENT STANDARD TREATMENTS, ELECTROCONVULSIVE THERAPY (ECT) AND IMIPRAMINE (IMN). METHODS: CONSENTING, UNTREATED MELANCHOLIC DEPRESSIVES (N=45) WERE HOSPITALIZED AND RANDOMIZED EQUALLY INTO THREE TREATMENT GROUPS. THEY WERE ASSESSED AT RECRUITMENT AND WEEKLY THEREAFTER FOR FOUR WEEKS. RESULTS: SIGNIFICANT REDUCTIONS IN THE TOTAL SCORES ON BECK DEPRESSION INVENTORY (BDI) AND HAMILTON RATING SCALE FOR DEPRESSION (HRSD) OCCURRED ON SUCCESSIVE OCCASIONS IN ALL THREE GROUPS. THE GROUPS, HOWEVER, DID NOT DIFFER. SIGNIFICANT INTERACTION BETWEEN THE GROUPS AND OCCASION OF ASSESSMENT OCCURRED. AT WEEK THREE, THE SKY GROUP HAD HIGHER SCORES THAN THE ECT GROUP BUT WAS NOT DIFFERENT FROM THE IMN GROUP. REMISSION (TOTAL HRSD SCORE OF SEVEN OR LESS) RATES AT THE END OF THE TRIAL WERE 93, 73 AND 67% IN THE ECT, IMN AND SKY GROUPS, RESPECTIVELY. NO CLINICALLY SIGNIFICANT SIDE EFFECTS WERE OBSERVED. DISCUSSION: WITHIN THE LIMITATIONS OF THE DESIGN (LACK OF DOUBLE BLIND CONDITIONS), IT CAN BE CONCLUDED THAT, ALTHOUGH INFERIOR TO ECT, SKY CAN BE A POTENTIAL ALTERNATIVE TO DRUGS IN MELANCHOLIA AS A FIRST LINE TREATMENT.	2000	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
4 2796  39 YOGA THERAPY FOR OBSESSIVE COMPULSIVE DISORDER (OCD): A CASE SERIES FROM INDIA. YOGA IS AN ANCIENT SCIENCE WHICH HAS BEEN FOUND TO BE HELPFUL IN THE MANAGEMENT OF SEVERAL PSYCHIATRIC DISORDERS INCLUDING OBSESSIVE COMPULSIVE DISORDER (OCD). YOGA AS ADD-ON TREATMENT IN OCD MAY HELP ADDRESS ISSUES LIKE PARTIAL RESPONSE AND ADVERSE EFFECTS OF MEDICATIONS. HOWEVER, RESEARCH IN THIS AREA IS SPARSE, WHICH LED US TO EXPLORE IT THROUGH THIS CASE SERIES. IN THIS CASE SERIES WE HAVE DESCRIBED THE BENEFITS OF 1 MONTH OF YOGA AS ADD-ON TREATMENT IN PATIENTS WITH OCD. ALL PATIENTS WERE ON STABLE DOSES OF MEDICATIONS PRIOR TO AND DURING YOGA PRACTICE. PRE-POST ASSESSMENTS FOR THE CORE SYMPTOMS OF OBSESSION/COMPULSIONS AS WELL AS DEPRESSIVE AND ANXIETY SYMPTOMS WERE DONE. THE ASSESSMENTS SHOWED SIGNIFICANT IMPROVEMENT IN Y-BOCS AND HAM-D SCORES AFTER 1 MONTH OF YOGA. YOGA THERAPY COULD BE AN EFFECTIVE ADD-ON THERAPY FOR THE TREATMENT OF OCD.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
5 2325  50 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
6  176  47 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
7  168  38 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
8  580  35 DESIGNING AND VALIDATION OF A YOGA-BASED INTERVENTION FOR OBSESSIVE COMPULSIVE DISORDER. SOME YOGA-BASED PRACTICES HAVE BEEN FOUND TO BE USEFUL FOR PATIENTS WITH OBSESSIVE COMPULSIVE DISORDER (OCD). THE AUTHORS COULD NOT FIND A VALIDATED YOGA THERAPY MODULE AVAILABLE FOR OCD. THIS STUDY ATTEMPTED TO FORMULATE A GENERIC YOGA-BASED INTERVENTION MODULE FOR OCD. A YOGA MODULE WAS DESIGNED BASED ON TRADITIONAL AND CONTEMPORARY YOGA LITERATURE. THE MODULE WAS SENT TO 10 YOGA EXPERTS FOR CONTENT VALIDATION. THE EXPERTS RATED THE USEFULNESS OF THE PRACTICES ON A SCALE OF 1-5 (5 = EXTREMELY USEFUL). THE FINAL VERSION OF THE MODULE WAS PILOT-TESTED ON PATIENTS WITH OCD (N = 17) FOR BOTH FEASIBILITY AND EFFECT ON SYMPTOMS. EIGHTY-EIGHT PER CENT (22 OUT OF 25) OF THE ITEMS IN THE INITIAL MODULE WERE RETAINED, WITH MODIFICATIONS IN THE MODULE AS SUGGESTED BY THE EXPERTS ALONG WITH PATIENTS' INPUTS AND AUTHORS' EXPERIENCE. THE MODULE WAS FOUND TO BE FEASIBLE AND SHOWED AN IMPROVEMENT IN SYMPTOMS OF OCD ON TOTAL YALE-BROWN OBSESSIVE-COMPULSIVE SCALE (YBOCS) SCORE (P = 0.001). A GENERIC YOGA THERAPY MODULE FOR OCD WAS VALIDATED BY EXPERTS IN THE FIELD AND FOUND FEASIBLE TO PRACTICE IN PATIENTS. A DECREASE IN THE SYMPTOM SCORES WAS ALSO FOUND FOLLOWING YOGA PRACTICE OF 2 WEEKS. FURTHER CLINICAL VALIDATION IS WARRANTED TO CONFIRM EFFICACY.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
9  258  45 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	
                                                                    
10   91  46 A MULTICOMPONENT YOGA-BASED, BREATH INTERVENTION PROGRAM AS AN ADJUNCTIVE TREATMENT IN PATIENTS SUFFERING FROM GENERALIZED ANXIETY DISORDER WITH OR WITHOUT COMORBIDITIES. OBJECTIVES: THE AIM OF THIS STUDY IS TO EVALUATE THE EFFICACY AND TOLERABILITY OF SUDARSHAN KRIYA YOGA (SKY) COURSE IN GENERALIZED ANXIETY DISORDER (GAD) OUTPATIENTS, WHO AFTER EIGHT WEEKS OF AN APPROPRIATE DOSE OF TRADITIONAL THERAPY HAD NOT YET ACHIEVED REMISSION. SUBJECTS: THE ADULT PARTICIPANTS (18-65 YEARS) WERE OUTPATIENTS WITH A PRIMARY DIAGNOSIS OF GAD WITH OR WITHOUT COMORBIDITIES ON THE MINI-INTERNATIONAL NEUROPSYCHIATRIC INTERVIEW (MINI). PARTICIPANTS HAD A MINIMUM OF EIGHT WEEKS STANDARD TREATMENT WITH AN APPROPRIATE DOSE OF A STANDARD PRESCRIPTION ANXIOLYTIC, A CLINICIAN GLOBAL IMPRESSION-SEVERITY (CGI-S) SCORE OF 5-7, A HAMILTON ANXIETY SCALE (HAM-A) TOTAL SCORE >/=20 INCLUDING A SCORE OF >2 ON THE ANXIOUS MOOD AND TENSION ITEMS. MATERIALS AND METHODS: FORTY-ONE PATIENTS WERE ENROLLED IN AN OPEN-LABEL TRIAL OF THE SKY COURSE AS AN ADJUNCT TO STANDARD TREATMENT OF GAD AT THE START CLINIC FOR MOOD AND ANXIETY DISORDERS, A TERTIARY CARE MOOD AND ANXIETY DISORDER CLINIC IN TORONTO. THE SKY COURSE WAS ADMINISTERED OVER FIVE DAYS (22 H TOTAL). SUBJECTS WERE ENCOURAGED TO PRACTICE THE YOGA BREATHING TECHNIQUES AT HOME FOR 20 MIN PER DAY AFTER THE COURSE AND WERE OFFERED GROUP PRACTICE SESSIONS FOR 2 H ONCE A WEEK LED BY CERTIFIED YOGA INSTRUCTORS. THE PRIMARY OUTCOME MEASURE WAS THE MEAN CHANGE FROM PRE-TREATMENT ON THE HAM-A SCALE. PSYCHOLOGICAL MEASURES WERE OBTAINED AT BASELINE AND FOUR WEEKS AFTER COMPLETING THE INTERVENTION. RESULTS: THIRTY-ONE PATIENTS COMPLETED THE PROGRAM (MEAN AGE 42.6 +/- 13.3 YEARS). AMONG COMPLETERS, SIGNIFICANT REDUCTIONS OCCURRED IN THE PRE- AND POST-INTERVENTION MEAN HAM-A TOTAL SCORE (T=4.59; P<0.01) AND PSYCHIC SUBSCALE (T=5.00; P</=0.01). THE RESPONSE RATE WAS 73% AND THE REMISSION RATE 41% AS MEASURED ON THE HAM-A. CONCLUSION: THE RESULTS OF THIS SMALL PILOT TRIAL SUGGEST THAT THE SKY COURSE REPRESENTS A POTENTIALLY VALUABLE ADJUNCT TO STANDARD PHARMACOTHERAPY IN PATIENTS WITH GAD OR TREATMENT-RESISTANT GAD, AND WARRANTS FURTHER INVESTIGATION. IN PARTICULAR, CHANGES IN WORRY AND BODY SYMPTOMS SHOWED SIGNIFICANT IMPROVEMENTS THAT MAY FURTHER OUR UNDERSTANDING OF THE MECHANISM OF CHANGE IN THE TOLERANCE OF ANXIETY AND WORRY.	2012	
                                                                                                                                                                                                                                                                                                                                                              
11 1831  49 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
12 2577  44 YOGA FOR GENERALIZED ANXIETY DISORDER: DESIGN OF A RANDOMIZED CONTROLLED CLINICAL TRIAL. GENERALIZED ANXIETY DISORDER (GAD) IS A COMMON DISORDER ASSOCIATED WITH SIGNIFICANT DISTRESS AND INTERFERENCE. ALTHOUGH COGNITIVE BEHAVIORAL THERAPY (CBT) HAS BEEN SHOWN TO BE THE MOST EFFECTIVE FORM OF PSYCHOTHERAPY, FEW PATIENTS RECEIVE OR HAVE ACCESS TO THIS INTERVENTION. YOGA THERAPY OFFERS ANOTHER PROMISING, YET UNDER-RESEARCHED, INTERVENTION THAT IS GAINING INCREASING POPULARITY IN THE GENERAL PUBLIC, AS AN ANXIETY REDUCTION INTERVENTION. THE PURPOSE OF THIS INNOVATIVE CLINICAL TRIAL PROTOCOL IS TO INVESTIGATE THE EFFICACY OF A KUNDALINI YOGA INTERVENTION, RELATIVE TO CBT AND A CONTROL CONDITION. KUNDALINI YOGA AND CBT ARE COMPARED WITH EACH OTHER IN A NONINFERIORITY TEST AND BOTH TREATMENTS ARE COMPARED TO STRESS EDUCATION TRAINING, AN ATTENTION CONTROL INTERVENTION, IN SUPERIORITY TESTS. THE SAMPLE WILL CONSIST OF 230 INDIVIDUALS WITH A PRIMARY DSM-5 DIAGNOSIS OF GAD. THIS RANDOMIZED CONTROLLED TRIAL WILL COMPARE YOGA (N=95) TO BOTH CBT FOR GAD (N=95) AND STRESS EDUCATION (N=40), A COMMONLY USED CONTROL CONDITION. ALL THREE TREATMENTS WILL BE ADMINISTERED BY TWO INSTRUCTORS IN A GROUP FORMAT OVER 12 WEEKLY SESSIONS WITH FOUR TO SIX PATIENTS PER GROUP. GROUPS WILL BE RANDOMIZED USING PERMUTED BLOCK RANDOMIZATION, WHICH WILL BE STRATIFIED BY SITE. TREATMENT OUTCOME WILL BE EVALUATED BI-WEEKLY AND AT 6MONTH FOLLOW-UP. FURTHERMORE, POTENTIAL MEDIATORS OF TREATMENT OUTCOME WILL BE INVESTIGATED. GIVEN THE INDIVIDUAL AND ECONOMIC BURDEN ASSOCIATED WITH GAD, IDENTIFYING ACCESSIBLE ALTERNATIVE BEHAVIORAL TREATMENTS WILL HAVE SUBSTANTIVE PUBLIC HEALTH IMPLICATIONS.	2015	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
13 2318  57 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	
                                                                                                                                                                                                                                                                                                                                                                                            
14 2831  45 YOGA VS. PHYSICAL THERAPY VS. EDUCATION FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY MINORITY POPULATIONS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN CAUSES SUBSTANTIAL MORBIDITY AND COST TO SOCIETY WHILE DISPROPORTIONATELY IMPACTING LOW-INCOME AND MINORITY ADULTS. SEVERAL RANDOMIZED CONTROLLED TRIALS SHOW YOGA IS AN EFFECTIVE TREATMENT. HOWEVER, THE COMPARATIVE EFFECTIVENESS OF YOGA AND PHYSICAL THERAPY, A COMMON MAINSTREAM TREATMENT FOR CHRONIC LOW BACK PAIN, IS UNKNOWN. METHODS/DESIGN: THIS IS A RANDOMIZED CONTROLLED TRIAL FOR 320 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN, COMPARING YOGA, PHYSICAL THERAPY, AND EDUCATION. INCLUSION CRITERIA ARE ADULTS 18-64 YEARS OLD WITH NON-SPECIFIC LOW BACK PAIN LASTING >/= 12 WEEKS AND A SELF-REPORTED AVERAGE PAIN INTENSITY OF >/= 4 ON A 0-10 SCALE. RECRUITMENT TAKES PLACE AT BOSTON MEDICAL CENTER, AN URBAN ACADEMIC SAFETY-NET HOSPITAL AND SEVEN FEDERALLY QUALIFIED COMMUNITY HEALTH CENTERS LOCATED IN DIVERSE NEIGHBORHOODS. THE 52-WEEK STUDY HAS AN INITIAL 12-WEEK TREATMENT PHASE WHERE PARTICIPANTS ARE RANDOMIZED IN A 2:2:1 RATIO INTO I) A STANDARDIZED WEEKLY HATHA YOGA CLASS SUPPLEMENTED BY HOME PRACTICE; II) A STANDARDIZED EVIDENCE-BASED EXERCISE THERAPY PROTOCOL ADAPTED FROM THE TREATMENT BASED CLASSIFICATION METHOD, INDIVIDUALLY DELIVERED BY A PHYSICAL THERAPIST AND SUPPLEMENTED BY HOME PRACTICE; AND III) EDUCATION DELIVERED THROUGH A SELF-CARE BOOK. CO-PRIMARY OUTCOME MEASURES ARE 12-WEEK PAIN INTENSITY MEASURED ON AN 11-POINT NUMERICAL RATING SCALE AND BACK-SPECIFIC FUNCTION MEASURED USING THE MODIFIED ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 40-WEEK MAINTENANCE PHASE, YOGA PARTICIPANTS ARE RE-RANDOMIZED IN A 1:1 RATIO TO EITHER STRUCTURED MAINTENANCE YOGA CLASSES OR HOME PRACTICE ONLY. PHYSICAL THERAPY PARTICIPANTS ARE SIMILARLY RE-RANDOMIZED TO EITHER FIVE BOOSTER SESSIONS OR HOME PRACTICE ONLY. EDUCATION PARTICIPANTS CONTINUE TO FOLLOW RECOMMENDATIONS OF EDUCATIONAL MATERIALS. WE WILL ALSO ASSESS COST EFFECTIVENESS FROM THE PERSPECTIVES OF THE INDIVIDUAL, INSURERS, AND SOCIETY USING CLAIMS DATABASES, ELECTRONIC MEDICAL RECORDS, SELF-REPORT COST DATA, AND STUDY RECORDS. QUALITATIVE DATA FROM INTERVIEWS WILL ADD SUBJECTIVE DETAIL TO COMPLEMENT QUANTITATIVE DATA. TRIAL REGISTRATION: THIS TRIAL IS REGISTERED IN CLINICALTRIALS.GOV, WITH THE ID NUMBER: NCT01343927.	2014	
                                                                                                                                                                                                                                                                                                       
15  232  43 A SYSTEMATIC REVIEW OF YOGA FOR MAJOR DEPRESSIVE DISORDER. BACKGROUND: THE PURPOSE OF THIS REVIEW WAS TO INVESTIGATE THE EFFICACY AND SAFETY OF YOGA INTERVENTIONS IN TREATING PATIENTS WITH MAJOR DEPRESSIVE DISORDER. METHODS: MEDLINE, SCOPUS, AND THE COCHRANE LIBRARY WERE SCREENED THROUGH DECEMBER 2016. RANDOMIZED CONTROLLED TRIALS (RCTS) COMPARING YOGA TO INACTIVE OR ACTIVE COMPARATORS IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER WERE ELIGIBLE. PRIMARY OUTCOMES INCLUDED REMISSION RATES AND SEVERITY OF DEPRESSION. ANXIETY AND ADVERSE EVENTS WERE SECONDARY OUTCOMES. RISK OF BIAS WAS ASSESSED USING THE COCHRANE TOOL. RESULTS: SEVEN RCTS WITH 240 PARTICIPANTS WERE INCLUDED. RISK OF BIAS WAS UNCLEAR FOR MOST RCTS. COMPARED TO AEROBIC EXERCISE, NO SHORT- OR MEDIUM-TERM GROUP DIFFERENCES IN DEPRESSION SEVERITY WAS FOUND. HIGHER SHORT-TERM DEPRESSION SEVERITY WAS FOUND FOR YOGA COMPARED TO ELECTRO-CONVULSIVE THERAPY; REMISSION RATES DID NOT DIFFER BETWEEN GROUPS. NO SHORT-TERM GROUP DIFFERENCES OCCURRED WHEN YOGA WAS COMPARED TO ANTIDEPRESSANT MEDICATION. CONFLICTING EVIDENCE WAS FOUND WHEN YOGA WAS COMPARED TO ATTENTION-CONTROL INTERVENTIONS, OR WHEN YOGA AS AN ADD-ON TO ANTIDEPRESSANT MEDICATION WAS COMPARED TO MEDICATION ALONE. ONLY TWO RCTS ASSESSED ADVERSE EVENTS AND REPORTED THAT NO TREATMENT-RELATED ADVERSE EVENTS WERE REPORTED. LIMITATIONS: FEW RCTS WITH LOW SAMPLE SIZE. CONCLUSIONS: THIS REVIEW FOUND SOME EVIDENCE FOR POSITIVE EFFECTS BEYOND PLACEBO AND COMPARABLE EFFECTS COMPARED TO EVIDENCE-BASED INTERVENTIONS. HOWEVER, METHODOLOGICAL PROBLEMS AND THE UNCLEAR RISK-BENEFIT RATIO PRECLUDE DEFINITIVE RECOMMENDATIONS FOR OR AGAINST YOGA AS AN ADJUNCT TREATMENT FOR MAJOR DEPRESSIVE DISORDER. LARGER AND ADEQUATELY POWERED RCTS USING NON-INFERIORITY DESIGNS ARE NEEDED.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
16 1130  39 EFFICACY OF YOGA FOR DEPRESSED POSTPARTUM WOMEN: A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: UP TO 20% OF WOMEN EXPERIENCE POSTPARTUM DEPRESSION (PPD). PPD IS ASSOCIATED WITH ANXIETY AND POOR HEALTH-RELATED QUALITY OF LIFE (HRQOL). EFFICACIOUS TREATMENTS ARE CRITICAL; MANY WOMEN WITH PPD PREFER COMPLEMENTARY THERAPIES. THUS, THE CURRENT STUDY EXAMINED YOGA AS A COMPLEMENTARY THERAPY FOR PPD. METHODS: FIFTY-SEVEN POSTPARTUM WOMEN WITH SCORES >/=12 ON THE HAMILTON DEPRESSION RATING SCALE WERE RANDOMLY ASSIGNED TO A YOGA (N = 28) OR WAIT-LIST CONTROL (N = 29) GROUP. THE YOGA INTERVENTION CONSISTED OF 16 CLASSES OVER 8 WEEKS. OUTCOMES WERE DEPRESSION, ANXIETY, AND HRQOL. RESULTS: THE YOGA GROUP EXPERIENCED SIGNIFICANTLY GREATER RATE OF IMPROVEMENT IN DEPRESSION, ANXIETY, AND HRQOL, RELATIVE TO THE CONTROL GROUP WITH MODERATE TO LARGE EFFECTS. RELIABLE CHANGE INDEX ANALYSES REVEALED THAT 78% OF WOMEN IN THE YOGA GROUP EXPERIENCED CLINICALLY SIGNIFICANT CHANGE. CONCLUSION: THESE FINDINGS SUPPORT YOGA AS A PROMISING COMPLEMENTARY THERAPY FOR PPD, AND WARRANT LARGE-SCALE REPLICATION STUDIES. TRIAL REGISTRATION: HTTP://CLINICALTRIALS.GOV/NCT02213601.	2015	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
17  217  46 A STUDY PROTOCOL OF A THREE-GROUP RANDOMIZED FEASIBILITY TRIAL OF AN ONLINE YOGA INTERVENTION FOR MOTHERS AFTER STILLBIRTH (THE MINDFUL HEALTH STUDY). BACKGROUND: IN THE USA, STILLBIRTH (IN UTERO FETAL DEATH >/=20 WEEKS GESTATION) IS A MAJOR PUBLIC HEALTH ISSUE. WOMEN WHO EXPERIENCE STILLBIRTH, COMPARED TO WOMEN WITH LIVE BIRTH, HAVE A NEARLY SEVENFOLD INCREASED RISK OF A POSITIVE SCREEN FOR POST-TRAUMATIC STRESS DISORDER (PTSD) AND A FOURFOLD INCREASED RISK OF DEPRESSIVE SYMPTOMS. BECAUSE THE MAJORITY OF WOMEN WHO HAVE EXPERIENCED THE DEATH OF THEIR BABY BECOME PREGNANT WITHIN 12-18 MONTHS AND THE LACK OF INTERVENTION STUDIES CONDUCTED WITHIN THIS POPULATION, NOVEL APPROACHES TARGETING PHYSICAL AND MENTAL HEALTH, SPECIFIC TO THE NEEDS OF THIS POPULATION, ARE CRITICAL. EVIDENCE SUGGESTS THAT YOGA IS EFFICACIOUS, SAFE, ACCEPTABLE, AND COST-EFFECTIVE FOR IMPROVING MENTAL HEALTH IN A VARIETY OF POPULATIONS, INCLUDING PREGNANT AND POSTPARTUM WOMEN. TO DATE, THERE ARE NO KNOWN STUDIES EXAMINING ONLINE-STREAMING YOGA AS A STRATEGY TO HELP MOTHERS COPE WITH PTSD SYMPTOMS AFTER STILLBIRTH. METHODS: THE PRESENT STUDY IS A TWO-PHASE RANDOMIZED CONTROLLED TRIAL. PHASE 1 WILL INVOLVE (1) AN ITERATIVE DESIGN PROCESS TO DEVELOP THE ONLINE YOGA PRESCRIPTION FOR PHASE 2 AND (2) QUALITATIVE INTERVIEWS TO IDENTIFY CULTURAL BARRIERS TO RECRUITMENT IN NON-CAUCASIAN WOMEN (I.E., PREDOMINATELY HISPANIC AND/OR AFRICAN AMERICAN) WHO HAVE EXPERIENCED STILLBIRTH (N = 5). PHASE 2 IS A THREE-GROUP RANDOMIZED FEASIBILITY TRIAL WITH ASSESSMENTS AT BASELINE, AND AT 12 AND 20 WEEKS POST-INTERVENTION. NINETY WOMEN WHO HAVE EXPERIENCED A STILLBIRTH WITHIN 6 WEEKS TO 24 MONTHS WILL BE RANDOMIZED INTO ONE OF THE FOLLOWING THREE ARMS FOR 12 WEEKS: (1) INTERVENTION LOW DOSE (LD) = 60 MIN/WEEK ONLINE-STREAMING YOGA (N = 30), (2) INTERVENTION MODERATE DOSE (MD) = 150 MIN/WEEK ONLINE-STREAMING YOGA (N = 30), OR (3) STRETCH AND TONE CONTROL (STC) GROUP = 60 MIN/WEEK OF STRETCHING/TONING EXERCISES (N = 30). DISCUSSION: THIS STUDY WILL EXPLORE THE FEASIBILITY AND ACCEPTABILITY OF A 12-WEEK, HOME-BASED, ONLINE-STREAMED YOGA INTERVENTION, WITH VARYING DOSES AMONG MOTHERS AFTER A STILLBIRTH. IF FEASIBLE, THE FINDINGS FROM THIS STUDY WILL INFORM A FULL-SCALE TRIAL TO DETERMINE THE EFFECTIVENESS OF HOME-BASED ONLINE-STREAMED YOGA TO IMPROVE PTSD. LONG-TERM, HEALTH CARE PROVIDERS COULD USE ONLINE YOGA AS A NON-PHARMACEUTICAL, INEXPENSIVE RESOURCE FOR STILLBIRTH AFTERCARE. TRIAL REGISTRATION: NCT02925481.	2018	
                                                                                                                                                                                                                                 
18 2857  46 YOGA-BASED CARDIAC REHABILITATION AFTER ACUTE MYOCARDIAL INFARCTION: A RANDOMIZED TRIAL. BACKGROUND: GIVEN THE SHORTAGE OF CARDIAC REHABILITATION (CR) PROGRAMS IN INDIA AND POOR UPTAKE WORLDWIDE, THERE IS AN URGENT NEED TO FIND ALTERNATIVE MODELS OF CR THAT ARE INEXPENSIVE AND MAY OFFER CHOICE TO SUBGROUPS WITH POOR UPTAKE (E.G., WOMEN AND ELDERLY). OBJECTIVES: THIS STUDY SOUGHT TO EVALUATE THE EFFECTS OF YOGA-BASED CR (YOGA-CARE) ON MAJOR CARDIOVASCULAR EVENTS AND SELF-RATED HEALTH IN A MULTICENTER RANDOMIZED CONTROLLED TRIAL. METHODS: THE TRIAL WAS CONDUCTED IN 24 MEDICAL CENTERS ACROSS INDIA. THIS STUDY RECRUITED 3,959 PATIENTS WITH ACUTE MYOCARDIAL INFARCTION WITH A MEDIAN AND MINIMUM FOLLOW-UP OF 22 AND 6 MONTHS. PATIENTS WERE INDIVIDUALLY RANDOMIZED TO RECEIVE EITHER A YOGA-CARE PROGRAM (N = 1,970) OR ENHANCED STANDARD CARE INVOLVING EDUCATIONAL ADVICE (N = 1,989). THE CO-PRIMARY OUTCOMES WERE: 1) FIRST OCCURRENCE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) (COMPOSITE OF ALL-CAUSE MORTALITY, MYOCARDIAL INFARCTION, STROKE, OR EMERGENCY CARDIOVASCULAR HOSPITALIZATION); AND 2) SELF-RATED HEALTH ON THE EUROPEAN QUALITY OF LIFE-5 DIMENSIONS-5 LEVEL VISUAL ANALOGUE SCALE AT 12 WEEKS. RESULTS: MACE OCCURRED IN 131 (6.7%) PATIENTS IN THE YOGA-CARE GROUP AND 146 (7.4%) PATIENTS IN THE ENHANCED STANDARD CARE GROUP (HAZARD RATIO WITH YOGA-CARE: 0.90; 95% CONFIDENCE INTERVAL [CI]: 0.71 TO 1.15; P = 0.41). SELF-RATED HEALTH WAS 77 IN YOGA-CARE AND 75.7 IN THE ENHANCED STANDARD CARE GROUP (BASELINE-ADJUSTED MEAN DIFFERENCE IN FAVOR OF YOGA-CARE: 1.5; 95% CI: 0.5 TO 2.5; P = 0.002). THE YOGA-CARE GROUP HAD GREATER RETURN TO PRE-INFARCT ACTIVITIES, BUT THERE WAS NO DIFFERENCE IN TOBACCO CESSATION OR MEDICATION ADHERENCE BETWEEN THE TREATMENT GROUPS (SECONDARY OUTCOMES). CONCLUSIONS: YOGA-CARE IMPROVED SELF-RATED HEALTH AND RETURN TO PRE-INFARCT ACTIVITIES AFTER ACUTE MYOCARDIAL INFARCTION, BUT THE TRIAL LACKED STATISTICAL POWER TO SHOW A DIFFERENCE IN MACE. YOGA-CARE MAY BE AN OPTION WHEN CONVENTIONAL CR IS UNAVAILABLE OR UNACCEPTABLE TO INDIVIDUALS. (A STUDY ON EFFECTIVENESS OF YOGA BASED CARDIAC REHABILITATION PROGRAMME IN INDIA AND UNITED KINGDOM; CTRI/2012/02/002408).	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
19 1543  30 KUNDALINI YOGA FOR GENERALIZED ANXIETY DISORDER: AN EXPLORATION OF TREATMENT EFFICACY AND POSSIBLE MECHANISMS. THE AIM OF THIS STUDY WAS TO EXAMINE THE EFFICACY OF KUNDALINI YOGA IN REDUCING SYMPTOMS OF GENERALIZED ANXIETY DISORDER (GAD) COMPARED TO A COMMON TREATMENT-AS-USUAL CONDITION USING COGNITIVE TECHNIQUES. A SECONDARY OBJECTIVE WAS TO EXPLORE POTENTIAL TREATMENT MECHANISMS. FEMALES AGED 24 TO 75 YEARS WITH GAD ( N = 49) RECEIVED EITHER AN 8-WEEK KUNDALINI YOGA INTERVENTION ( N = 34) OR AN 8-WEEK TREATMENT-AS-USUAL CONDITION ( N = 15). THE YOGA CONDITION RESULTED IN LOWER LEVELS OF ANXIETY RELATIVE TO THE TREATMENT-AS-USUAL CONDITION. FURTHERMORE, CHANGES IN SOMATIC SYMPTOMS MEDIATED TREATMENT OUTCOME FOR KUNDALINI YOGA. KUNDALINI YOGA MAY SHOW PROMISE AS A TREATMENT FOR GAD, AND THIS TREATMENT MIGHT CONVEY ITS EFFECT ON SYMPTOM SEVERITY BY REDUCING SOMATIC SYMPTOMS.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
20 1140  58 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