1 1820 187 PROTOCOL FOR A RANDOMIZED CONTROLLED STUDY OF IYENGAR YOGA FOR YOUTH WITH IRRITABLE BOWEL SYNDROME. INTRODUCTION: IRRITABLE BOWEL SYNDROME AFFECTS AS MANY AS 14% OF HIGH SCHOOL-AGED STUDENTS. SYMPTOMS INCLUDE DISCOMFORT IN THE ABDOMEN, ALONG WITH DIARRHEA AND/OR CONSTIPATION AND OTHER GASTROENTEROLOGICAL SYMPTOMS THAT CAN SIGNIFICANTLY IMPACT QUALITY OF LIFE AND DAILY FUNCTIONING. EMOTIONAL STRESS APPEARS TO EXACERBATE IRRITABLE BOWEL SYNDROME SYMPTOMS SUGGESTING THAT MIND-BODY INTERVENTIONS REDUCING AROUSAL MAY PROVE BENEFICIAL. FOR MANY SUFFERERS, SYMPTOMS CAN BE TRACED TO CHILDHOOD AND ADOLESCENCE, MAKING THE EARLY MANIFESTATION OF IRRITABLE BOWEL SYNDROME IMPORTANT TO UNDERSTAND. THE CURRENT STUDY WILL FOCUS ON YOUNG PEOPLE AGED 14-26 YEARS WITH IRRITABLE BOWEL SYNDROME. THE STUDY WILL TEST THE POTENTIAL BENEFITS OF IYENGAR YOGA ON CLINICAL SYMPTOMS, PSYCHOSPIRITUAL FUNCTIONING AND VISCERAL SENSITIVITY. YOGA IS THOUGHT TO BRING PHYSICAL, PSYCHOLOGICAL AND SPIRITUAL BENEFITS TO PRACTITIONERS AND HAS BEEN ASSOCIATED WITH REDUCED STRESS AND PAIN. THROUGH ITS FOCUS ON RESTORATION AND USE OF PROPS, IYENGAR YOGA IS ESPECIALLY DESIGNED TO DECREASE AROUSAL AND PROMOTE PSYCHOSPIRITUAL RESOURCES IN PHYSICALLY COMPROMISED INDIVIDUALS. AN EXTENSIVE AND STANDARDIZED TEACHER-TRAINING PROGRAM SUPPORT IYENGAR YOGA'S RELIABILITY AND SAFETY. IT IS HYPOTHESIZED THAT YOGA WILL BE FEASIBLE WITH LESS THAN 20% ATTRITION; AND THE YOGA GROUP WILL DEMONSTRATE SIGNIFICANTLY IMPROVED OUTCOMES COMPARED TO CONTROLS, WITH PHYSIOLOGICAL AND PSYCHOSPIRITUAL MECHANISMS CONTRIBUTING TO IMPROVEMENTS. METHODS/DESIGN: SIXTY IRRITABLE BOWEL SYNDROME PATIENTS AGED 14-26 WILL BE RANDOMLY ASSIGNED TO A STANDARDIZED 6-WEEK TWICE WEEKLY IYENGAR YOGA GROUP-BASED PROGRAM OR A WAIT-LIST USUAL CARE CONTROL GROUP. THE GROUPS WILL BE COMPARED ON THE PRIMARY CLINICAL OUTCOMES OF IRRITABLE BOWEL SYNDROME SYMPTOMS, QUALITY OF LIFE AND GLOBAL IMPROVEMENT AT POST-TREATMENT AND 2-MONTH FOLLOW-UP. SECONDARY OUTCOMES WILL INCLUDE VISCERAL PAIN SENSITIVITY ASSESSED WITH A STANDARDIZED LABORATORY TASK (WATER LOAD TASK), FUNCTIONAL DISABILITY AND PSYCHOSPIRITUAL VARIABLES INCLUDING CATASTROPHIZING, SELF-EFFICACY, MOOD, ACCEPTANCE AND MINDFULNESS. MECHANISMS OF ACTION INVOLVED IN THE PROPOSED BENEFICIAL EFFECTS OF YOGA UPON CLINICAL OUTCOMES WILL BE EXPLORED, AND INCLUDE THE MEDIATING EFFECTS OF VISCERAL SENSITIVITY, INCREASED PSYCHOSPIRITUAL RESOURCES, REGULATED AUTONOMIC NERVOUS SYSTEM RESPONSES AND REGULATED HORMONAL STRESS RESPONSE ASSESSED VIA SALIVARY CORTISOL. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT01107977. 2011 2 194 44 A RANDOMIZED TRIAL OF YOGA FOR ADOLESCENTS WITH IRRITABLE BOWEL SYNDROME. BACKGROUND: ADOLESCENTS WITH IRRITABLE BOWEL SYNDROME (IBS) FREQUENTLY EXPERIENCE INTERFERENCE WITH EVERYDAY ACTIVITIES. MIND-BODY APPROACHES SUCH AS YOGA HAVE BEEN RECOMMENDED AS INTERVENTIONS FOR PATIENTS WITH IBS. DESPITE PROMISING RESULTS AMONG ADULT SAMPLES, THERE HAVE BEEN LIMITED STUDIES EXPLORING THE EFFICACY OF YOGA WITH PEDIATRIC PATIENTS. OBJECTIVE: TO CONDUCT A PRELIMINARY RANDOMIZED STUDY OF YOGA AS TREATMENT FOR ADOLESCENTS WITH IBS. METHODS: TWENTY-FIVE ADOLESCENTS AGED 11 TO 18 YEARS WITH IBS WERE RANDOMLY ASSIGNED TO EITHER A YOGA OR WAIT LIST CONTROL GROUP. BEFORE THE INTERVENTION, BOTH GROUPS COMPLETED QUESTIONNAIRES ASSESSING GASTROINTESTINAL SYMPTOMS, PAIN, FUNCTIONAL DISABILITY, COPING, ANXIETY AND DEPRESSION. THE YOGA INTERVENTION CONSISTED OF A 1 H INSTRUCTIONAL SESSION, DEMONSTRATION AND PRACTICE, FOLLOWED BY FOUR WEEKS OF DAILY HOME PRACTICE GUIDED BY A VIDEO. AFTER FOUR WEEKS, ADOLESCENTS REPEATED THE BASELINE QUESTIONNAIRES. THE WAIT LIST CONTROL GROUP THEN RECEIVED THE YOGA INTERVENTION AND FOUR WEEKS LATER COMPLETED AN ADDITIONAL SET OF QUESTIONNAIRES. RESULTS: ADOLESCENTS IN THE YOGA GROUP REPORTED LOWER LEVELS OF FUNCTIONAL DISABILITY, LESS USE OF EMOTION-FOCUSED AVOIDANCE AND LOWER ANXIETY FOLLOWING THE INTERVENTION THAN ADOLESCENTS IN THE CONTROL GROUP. WHEN THE PRE- AND POSTINTERVENTION DATA FOR THE TWO GROUPS WERE COMBINED, ADOLESCENTS HAD SIGNIFICANTLY LOWER SCORES FOR GASTROINTESTINAL SYMPTOMS AND EMOTION-FOCUSED AVOIDANCE FOLLOWING THE YOGA INTERVENTION. ADOLESCENTS FOUND THE YOGA TO BE HELPFUL AND INDICATED THEY WOULD CONTINUE TO USE IT TO MANAGE THEIR IBS. CONCLUSIONS: YOGA HOLDS PROMISE AS AN INTERVENTION FOR ADOLESCENTS WITH IBS. 2006 3 2468 39 YOGA AS A THERAPY FOR IRRITABLE BOWEL SYNDROME. THE AIM OF THIS STATE-OF-THE-ART NARRATIVE REVIEW IS TO EVALUATE THE CURRENT EVIDENCE ABOUT THE EFFECTIVENESS OF YOGA AS THERAPY FOR IBS AND EXPLORE ITS POTENTIAL MECHANISMS OF ACTION. THE CURRENT LITERATURE SUGGESTS YOGA IS EFFECTIVE AND SAFE AND MAY TARGET MULTIPLE MECHANISMS INVOLVED IN TREATMENT OF IBS. EVIDENCE FROM RANDOMIZED CONTROLLED TRIALS IDENTIFIED YOGA AS MORE EFFECTIVE COMPARED TO PHARMACOLOGICAL TREATMENT AND EQUALLY EFFECTIVE AS DIETARY INTERVENTIONS OR MODERATE-INTENSITY WALKING. IMPROVEMENTS WERE SEEN IN BOTH PHYSICAL HEALTH (IBS SYMPTOM SEVERITY, GASTRIC MOTILITY, AUTONOMIC AND SOMATIC SYMPTOM SCORES, AND PHYSICAL FUNCTIONING) AND MENTAL HEALTH OUTCOMES (DEPRESSION, ANXIETY, GASTROINTESTINAL-SPECIFIC ANXIETY, AND QUALITY OF LIFE). GIVEN FAVORABLE CHANGES IN IBS-RELATED PHYSICAL AND MENTAL HEALTH OUTCOMES, PRELIMINARY DATA SUPPORTS YOGA AS BENEFICIAL IN THIS POPULATION. HOWEVER, THE RELATIVELY LOW-QUALITY EVIDENCE RESULTING FROM HETEROGENEITY OF STUDY DESIGNS, INTERVENTIONS, AND OUTCOME MEASURES LIMIT OUR ABILITY TO MAKE SPECIFIC RECOMMENDATIONS ABOUT THE USE OF YOGA AS THERAPY FOR PATIENTS WITH IBS. 2020 4 175 56 A RANDOMIZED CONTROLLED TRIAL EXAMINING IYENGAR YOGA FOR YOUNG ADULTS WITH RHEUMATOID ARTHRITIS: A STUDY PROTOCOL. BACKGROUND: RHEUMATOID ARTHRITIS IS A CHRONIC, DISABLING DISEASE THAT CAN COMPROMISE MOBILITY, DAILY FUNCTIONING, AND HEALTH-RELATED QUALITY OF LIFE, ESPECIALLY IN OLDER ADOLESCENTS AND YOUNG ADULTS. IN THIS PROJECT, WE WILL COMPARE A STANDARDIZED IYENGAR YOGA PROGRAM FOR YOUNG PEOPLE WITH RHEUMATOID ARTHRITIS TO A STANDARD CARE WAIT-LIST CONTROL CONDITION. METHODS/DESIGN: SEVENTY RHEUMATOID ARTHRITIS PATIENTS AGED 16-35 YEARS WILL BE RANDOMIZED INTO EITHER THE 6-WEEK IYENGAR YOGA PROGRAM (12 - 1.5 HOUR SESSIONS TWICE WEEKLY) OR THE 6-WEEK WAIT-LIST CONTROL CONDITION. A 20% ATTRITION RATE IS ANTICIPATED. THE WAIT-LIST GROUP WILL RECEIVE THE YOGA PROGRAM FOLLOWING COMPLETION OF THE FIRST ARM OF THE STUDY. WE WILL COLLECT DATA QUANTITATIVELY, USING QUESTIONNAIRES AND MARKERS OF DISEASE ACTIVITY, AND QUALITATIVELY USING SEMI-STRUCTURED INTERVIEWS. ASSESSMENTS INCLUDE STANDARDIZED MEASURES OF GENERAL AND ARTHRITIS-SPECIFIC FUNCTION, PAIN, MOOD, AND HEALTH-RELATED QUALITY OF LIFE, AS WELL AS QUALITATIVE INTERVIEWS, BLOOD PRESSURE/RESTING HEART RATE MEASUREMENTS, A MEDICAL EXAM AND THE ASSESSMENT OF PRO-INFLAMMATORY CYTOKINES. DATA WILL BE COLLECTED THREE TIMES: BEFORE TREATMENT, POST-TREATMENT, AND TWO MONTHS FOLLOWING THE TREATMENT. DISCUSSION: RESULTS FROM THIS STUDY WILL PROVIDE CRITICAL DATA ON NON-PHARMACOLOGIC METHODS FOR ENHANCING FUNCTION IN RHEUMATOID ARTHRITIS PATIENTS. IN PARTICULAR, RESULTS WILL SHED LIGHT ON THE FEASIBILITY AND POTENTIAL EFFICACY OF A NOVEL INTERVENTION FOR RHEUMATOID ARTHRITIS SYMPTOMS, PAVING THE WAY FOR A LARGER CLINICAL TRIAL. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT01096823. 2011 5 2625 51 YOGA FOR TEENS WITH IRRITABLE BOWEL SYNDROME: RESULTS FROM A MIXED-METHODS PILOT STUDY. IRRITABLE BOWEL SYNDROME (IBS) IS A COMMON CONDITION ASSOCIATED WITH RECURRENT ABDOMINAL PAIN AND ALTERED BOWEL HABITS. IT IS PARTICULARLY PERNICIOUS TO YOUTH, WHO MAY WITHDRAW FROM LIFE TASKS DUE TO PAIN, DIARRHEA, AND/OR FEAR OF SYMPTOMS. EMOTIONAL STRESS EXACERBATES IBS SYMPTOMS, AND MIND-BODY INTERVENTIONS MAY BE BENEFICIAL. IN THIS MIXED-METHODS STUDY OF 18 TEENS AGED 14 TO 17 YEARS UNDERTAKING A 6-WEEK IYENGAR YOGA INTERVENTION, WE AIMED TO IDENTIFY TREATMENT RESPONDERS AND TO EXPLORE DIFFERENCES BETWEEN RESPONDERS AND NONRESPONDERS ON A RANGE OF QUANTITATIVE OUTCOMES AND QUALITATIVE THEMES RELATED TO YOGA IMPACT, GOODNESS OF FIT, AND BARRIERS TO TREATMENT. HALF OF THE TEENS RESPONDED SUCCESSFULLY TO YOGA, DEFINED AS A CLINICALLY MEANINGFUL REDUCTION IN ABDOMINAL PAIN. RESPONDERS DIFFERED FROM NONRESPONDERS ON POSTINTERVENTION QUANTITATIVE OUTCOMES, INCLUDING REDUCED ABDOMINAL PAIN, IMPROVED SLEEP, AND INCREASED VISCERAL SENSITIVITY. QUALITATIVE OUTCOMES REVEALED THAT RESPONDERS REPORTED GENERALIZED BENEFITS EARLY IN TREATMENT AND THAT THEIR PARENTS WERE SUPPORTIVE AND COMMITTED TO THE INTERVENTION. RESPONDERS AND NONRESPONDERS ALIKE NOTED THE IMPORTANCE OF HOME PRACTICE TO ACHIEVE MAXIMAL, SUSTAINED BENEFITS. THIS STUDY REVEALS THE NEED FOR DEVELOPMENTALLY SENSITIVE YOGA PROGRAMS THAT INCREASE ACCESSIBILITY OF YOGA FOR ALL PATIENTS. 2018 6 115 29 A PILOT STUDY OF A YOGA INTERVENTION FOR THE TREATMENT OF ANXIETY IN YOUNG PEOPLE WITH EARLY PSYCHOSIS. BACKGROUND: ANXIETY IS COMMON IN YOUNG PEOPLE WITH EARLY PSYCHOSIS AND TREATMENT OPTIONS FOR THIS CO-MORBIDITY REMAIN LIMITED. YOGA IS A PROMISING ADJUNCT INTERVENTION THAT HAS BEEN SHOWN TO REDUCE ANXIETY FOR ADULTS WITH SCHIZOPHRENIA, THEREFORE THIS PILOT STUDY EVALUATED THE ACCEPTABILITY AND POTENTIAL EFFECTIVENESS OF YOGA FOR ANXIETY IN EARLY PSYCHOSIS. METHODS: A PROSPECTIVE SINGLE ARM PILOT STUDY OF A YOGA INTERVENTION WAS CONDUCTED WITHIN AN EARLY INTERVENTION FOR PSYCHOSIS SERVICE. RATES OF ATTENDANCE, AS WELL AS SYMPTOMS OF ANXIETY PRE AND POST YOGA SESSION WERE MEASURED. RESULTS: A TOTAL OF 14 YOUNG PEOPLE PARTICIPATED IN THE STUDY AND OVER 70% ATTENDED HALF OR MORE OF THE YOGA SESSIONS OFFERED. SIGNIFICANT TRANSIENT REDUCTION IN STATE ANXIETY AFTER A SINGLE SESSION OF YOGA WAS OBSERVED (P < 0.01). CONCLUSIONS: YOGA WAS FOUND TO BE AN ACCEPTABLE AND POTENTIALLY EFFECTIVE ADJUNCTIVE TREATMENT FOR ANXIETY IN EARLY PSYCHOSIS AND THE RESULTS WARRANT FURTHER CLINICAL TRIALS. 2022 7 1770 40 POTENTIAL LONG-TERM EFFECTS OF A MIND-BODY INTERVENTION FOR WOMEN WITH MAJOR DEPRESSIVE DISORDER: SUSTAINED MENTAL HEALTH IMPROVEMENTS WITH A PILOT YOGA INTERVENTION. DESPITE PHARMACOLOGIC AND PSYCHOTHERAPEUTIC ADVANCES OVER THE PAST DECADES, MANY INDIVIDUALS WITH MAJOR DEPRESSIVE DISORDER (MDD) EXPERIENCE RECURRENT DEPRESSIVE EPISODES AND PERSISTENT DEPRESSIVE SYMPTOMS DESPITE TREATMENT WITH THE USUAL CARE. YOGA IS A MIND-BODY THERAPEUTIC MODALITY THAT HAS RECEIVED ATTENTION IN BOTH THE LAY AND RESEARCH LITERATURE AS A POSSIBLE ADJUNCTIVE THERAPY FOR DEPRESSION. ALTHOUGH PROMISING, RECENT FINDINGS ABOUT THE POSITIVE MENTAL HEALTH EFFECTS OF YOGA ARE LIMITED BECAUSE FEW STUDIES HAVE USED STANDARDIZED OUTCOME MEASURES AND NONE OF THEM HAVE INVOLVED LONG-TERM FOLLOW-UP BEYOND A FEW MONTHS AFTER THE INTERVENTION PERIOD. THE GOAL OF OUR RESEARCH STUDY WAS TO EVALUATE THE FEASIBILITY, ACCEPTABILITY, AND EFFECTS OF A YOGA INTERVENTION FOR WOMEN WITH MDD USING STANDARDIZED OUTCOME MEASURES AND A LONG FOLLOW-UP PERIOD (1YEAR AFTER THE INTERVENTION). THE KEY FINDING IS THAT PREVIOUS YOGA PRACTICE HAS LONG-TERM POSITIVE EFFECTS, AS REVEALED IN BOTH QUALITATIVE REPORTS OF PARTICIPANTS' EXPERIENCES AND IN THE QUANTITATIVE DATA ABOUT DEPRESSION AND RUMINATION SCORES OVER TIME. ALTHOUGH GENERALIZABILITY OF THE STUDY FINDINGS IS LIMITED BECAUSE OF A VERY SMALL SAMPLE SIZE AT THE 1-YEAR FOLLOW-UP ASSESSMENT, THE TRENDS IN THE DATA SUGGEST THAT EXPOSURE TO YOGA MAY CONVEY A SUSTAINED POSITIVE EFFECT ON DEPRESSION, RUMINATIONS, STRESS, ANXIETY, AND HEALTH-RELATED QUALITY OF LIFE. WHETHER AN INDIVIDUAL CONTINUES WITH YOGA PRACTICE, SIMPLE EXPOSURE TO A YOGA INTERVENTION APPEARS TO PROVIDE SUSTAINED BENEFITS TO THE INDIVIDUAL. THIS IS IMPORTANT BECAUSE IT IS RARE THAT ANY INTERVENTION, PHARMACOLOGIC OR NON-PHARMACOLOGIC, FOR DEPRESSION CONVEYS SUCH SUSTAINED EFFECTS FOR INDIVIDUALS WITH MDD, PARTICULARLY AFTER THE TREATMENT IS DISCONTINUED. 2014 8 1239 36 FEASIBILITY OF A MANUALIZED MINDFUL YOGA INTERVENTION FOR PATIENTS WITH CHRONIC MOOD DISORDERS. CHRONIC MOOD DISORDERS POSE AN IMPORTANT MENTAL HEALTH PROBLEM. INDIVIDUALS WITH THESE DISORDERS EXPERIENCE A SIGNIFICANT IMPAIRMENT, OFTEN FAIL TO SEEK HELP, AND THEIR ILLNESSES FREQUENTLY DO NOT RESPOND TO TREATMENT. IT IS THEREFORE IMPORTANT TO DEVELOP INNOVATIVE AND ATTRACTIVE TREATMENTS FOR THESE DISORDERS. MINDFUL YOGA REPRESENTS A PROMISING TREATMENT APPROACH. THIS PILOT STUDY TESTED THE FEASIBILITY OF A 9-WEEK MANUALIZED MINDFUL YOGA INTERVENTION FOR PATIENTS WITH CHRONIC MOOD DISORDERS. ELEVEN PATIENTS RECEIVING STANDARD TREATMENT WERE RECRUITED TO COMPLETE A 9-WEEK MINDFUL YOGA INTERVENTION. QUALITATIVE METHODS WERE USED TO ASSESS PATIENTS' EXPERIENCES OF THE INTERVENTION AND QUANTITATIVE METHODS WERE USED TO ASSESS PSYCHOLOGICAL DISTRESS AND MECHANISMS THAT PLAY A ROLE IN CHRONIC MOOD DISORDERS. EIGHT PATIENTS COMPLETED THE INTERVENTION AND RATED THE OVERALL QUALITY OF THE INTERVENTION WITH A MEAN SCORE OF 8.8 (RANGE OF 8 TO 9, USING A SCALE OF 1 TO 10). ALL PARTICIPANTS REPORTED A REDUCTION IN PSYCHOLOGICAL DISTRESS AND NO ADVERSE EVENTS. AMONG THE MECHANISMS THAT PLAY A ROLE IN CHRONIC MOOD DISORDERS, THE MOST POTENTIALLY PROMISING EFFECTS FROM THE INTERVENTION WERE FOUND FOR WORRY, FEAR OF DEPRESSION AND ANXIETY, RUMINATION, AND AREAS RELATED TO BODY AWARENESS, SUCH AS TRUSTING BODILY EXPERIENCES AND NOT DISTRACTING FROM SENSATIONS OF DISCOMFORT. A 9-WEEK MINDFUL YOGA INTERVENTION APPEARS TO BE A FEASIBLE AND ATTRACTIVE TREATMENT WHEN ADDED TO TREATMENT AS USUAL FOR A GROUP OF PATIENTS WITH CHRONIC MOOD DISORDERS. A RANDOMIZED CONTROLLED TRIAL TO STUDY THE EFFECTS OF MINDFUL YOGA IS RECOMMENDED. 2021 9 1373 40 IMPACT OF A YOGA INTERVENTION ON PHYSICAL ACTIVITY, SELF-EFFICACY, AND MOTIVATION IN WOMEN WITH PTSD SYMPTOMS. BACKGROUND: STUDIES USING YOGA HAVE DEMONSTRATED INITIAL EFFICACY FOR TREATING SYMPTOMS ACROSS ANXIETY DISORDERS, INCLUDING POSTTRAUMATIC STRESS DISORDER. OBJECTIVE: UNDERSTANDING HOW INTERVENTIONS INFLUENCE PARTICIPANTS' PHYSICAL ACTIVITY AND WHAT DETERMINANTS AFFECT CONTINUED PHYSICAL ACTIVITY BEHAVIOR CHANGE IS IMPORTANT BECAUSE MAINTENANCE OF THE BEHAVIOR MAY BE CRITICAL TO CONTINUED MENTAL HEALTH GAINS AND SYMPTOM REDUCTION. METHODS: THIS STUDY INVESTIGATED CHANGE IN PHYSICAL ACTIVITY AND POSSIBLE PSYCHOLOGICAL MECHANISMS OF PHYSICAL ACTIVITY BEHAVIOR CHANGE, INCLUDING SELF-EFFICACY AND REGULATORY MOTIVATION, IN A RANDOMIZED CONTROLLED TRIAL OF YOGA FOR WOMEN WITH POST-TRAUMATIC STRESS DISORDER SYMPTOMS (N=38). RESULTS: GROWTH CURVE MODELING RESULTS SHOWED NO SIGNIFICANT CHANGES IN PHYSICAL ACTIVITY OR SELF-EFFICACY FOR EITHER GROUP, WHEREAS EXTERNAL MOTIVATION DECREASED SIGNIFICANTLY IN THE YOGA GROUP BUT NOT IN THE CONTROL GROUP. CONCLUSIONS: INVESTIGATORS OF FUTURE YOGA INTERVENTIONS MAY WANT TO FOCUS ON INCREASING SELF-EFFICACY AND INTERNAL REGULATORY MOTIVATION, SO THAT PHYSICAL ACTIVITY AND RESULTANT SYMPTOM RELIEF CAN BE MAINTAINED. 2015 10 2170 38 THE EFFECTS OF YOGA ON ANXIETY AND STRESS. STRESS AND ANXIETY HAVE BEEN IMPLICATED AS CONTRIBUTORS TO MANY CHRONIC DISEASES AND TO DECREASED QUALITY OF LIFE, EVEN WITH PHARMACOLOGIC TREATMENT. EFFORTS ARE UNDERWAY TO FIND NON-PHARMACOLOGIC THERAPIES TO RELIEVE STRESS AND ANXIETY, AND YOGA IS ONE OPTION FOR WHICH RESULTS ARE PROMISING. THE FOCUS OF THIS REVIEW IS ON THE RESULTS OF HUMAN TRIALS ASSESSING THE ROLE OF YOGA IN IMPROVING THE SIGNS AND SYMPTOMS OF STRESS AND ANXIETY. OF 35 TRIALS ADDRESSING THE EFFECTS OF YOGA ON ANXIETY AND STRESS, 25 NOTED A SIGNIFICANT DECREASE IN STRESS AND/OR ANXIETY SYMPTOMS WHEN A YOGA REGIMEN WAS IMPLEMENTED; HOWEVER, MANY OF THE STUDIES WERE ALSO HINDERED BY LIMITATIONS, SUCH AS SMALL STUDY POPULATIONS, LACK OF RANDOMIZATION, AND LACK OF A CONTROL GROUP. FOURTEEN OF THE 35 STUDIES REPORTED BIOCHEMICAL AND PHYSIOLOGICAL MARKERS OF STRESS AND ANXIETY, BUT YIELDED INCONSISTENT SUPPORT OF YOGA FOR RELIEF OF STRESS AND ANXIETY. EVALUATION OF THE CURRENT PRIMARY LITERATURE IS SUGGESTIVE OF BENEFITS OF YOGA IN RELIEVING STRESS AND ANXIETY, BUT FURTHER INVESTIGATION INTO THIS RELATIONSHIP USING LARGE, WELL-DEFINED POPULATIONS, ADEQUATE CONTROLS, RANDOMIZATION AND LONG DURATION SHOULD BE EXPLORED BEFORE RECOMMENDING YOGA AS A TREATMENT OPTION. 2012 11 2458 42 YOGA AS A COMPLEMENTARY TREATMENT OF DEPRESSION: EFFECTS OF TRAITS AND MOODS ON TREATMENT OUTCOME. PRELIMINARY FINDINGS SUPPORT THE POTENTIAL OF YOGA AS A COMPLEMENTARY TREATMENT OF DEPRESSED PATIENTS WHO ARE TAKING ANTI-DEPRESSANT MEDICATIONS BUT WHO ARE ONLY IN PARTIAL REMISSION. THE PURPOSE OF THIS ARTICLE IS TO PRESENT FURTHER DATA ON THE INTERVENTION, FOCUSING ON INDIVIDUAL DIFFERENCES IN PSYCHOLOGICAL, EMOTIONAL AND BIOLOGICAL PROCESSES AFFECTING TREATMENT OUTCOME. TWENTY-SEVEN WOMEN AND 10 MEN WERE ENROLLED IN THE STUDY, OF WHOM 17 COMPLETED THE INTERVENTION AND PRE- AND POST-INTERVENTION ASSESSMENT DATA. THE INTERVENTION CONSISTED OF 20 CLASSES LED BY SENIOR IYENGAR YOGA TEACHERS, IN THREE COURSES OF 20 YOGA CLASSES EACH. ALL PARTICIPANTS WERE DIAGNOSED WITH UNIPOLAR MAJOR DEPRESSION IN PARTIAL REMISSION. PSYCHOLOGICAL AND BIOLOGICAL CHARACTERISTICS WERE ASSESSED PRE- AND POST-INTERVENTION, AND PARTICIPANTS RATED THEIR MOOD STATES BEFORE AND AFTER EACH CLASS. SIGNIFICANT REDUCTIONS WERE SHOWN FOR DEPRESSION, ANGER, ANXIETY, NEUROTIC SYMPTOMS AND LOW FREQUENCY HEART RATE VARIABILITY IN THE 17 COMPLETERS. ELEVEN OUT OF THESE COMPLETERS ACHIEVED REMISSION LEVELS POST-INTERVENTION. PARTICIPANTS WHO REMITTED DIFFERED FROM THE NON-REMITTERS AT INTAKE ON SEVERAL TRAITS AND ON PHYSIOLOGICAL MEASURES INDICATIVE OF A GREATER CAPACITY FOR EMOTIONAL REGULATION. MOODS IMPROVED FROM BEFORE TO AFTER THE YOGA CLASSES. YOGA APPEARS TO BE A PROMISING INTERVENTION FOR DEPRESSION; IT IS COST-EFFECTIVE AND EASY TO IMPLEMENT. IT PRODUCES MANY BENEFICIAL EMOTIONAL, PSYCHOLOGICAL AND BIOLOGICAL EFFECTS, AS SUPPORTED BY OBSERVATIONS IN THIS STUDY. THE PHYSIOLOGICAL METHODS ARE ESPECIALLY USEFUL AS THEY PROVIDE OBJECTIVE MARKERS OF THE PROCESSES AND EFFECTIVENESS OF TREATMENT. THESE OBSERVATIONS MAY HELP GUIDE FURTHER CLINICAL APPLICATION OF YOGA IN DEPRESSION AND OTHER MENTAL HEALTH DISORDERS, AND FUTURE RESEARCH ON THE PROCESSES AND MECHANISMS. 2007 12 142 29 A PROTOCOL AND PILOT STUDY FOR MANAGING FIBROMYALGIA WITH YOGA AND MEDITATION. FIBROMYALGIA IS A CHRONIC SYNDROME CHARACTERIZED BY WIDESPREAD PAIN, SLEEP DISTURBANCE, STIFFNESS, FATIGUE, HEADACHE, AND MOOD DISORDERS. RECENT RESEARCH HAS RESULTED IN AN IMPROVED UNDERSTANDING OF FIBROMYALGIA AND ITS POSSIBLE CAUSES. THIS ARTICLE HIGHLIGHTS SOME OF THE CURRENT RESEARCH, DISCUSSES A STRATEGY FOR USING YOGA AND MEDITATION AS A THERAPY FOR FIBROMYALGIA SUFFERERS, AND PRESENTS THE RESULTS OF A PRELIMINARY 8-WEEK STUDY USING YOGA AND MEDITATION TO HELP MANAGE FIBROMYALGIA SYMPTOMS. THE STUDY OF 11 PARTICIPANTS FOUND SIGNIFICANT IMPROVEMENT IN THE OVERALL HEALTH STATUS OF THE PARTICIPANTS AND IN SYMPTOMS OF STIFFNESS, ANXIETY, AND DEPRESSION. SIGNIFICANT IMPROVEMENTS WERE ALSO SEEN IN THE REPORTED NUMBER OF DAYS "FELT GOOD" AND NUMBER OF DAYS "MISSED WORK" BECAUSE OF FIBROMYALGIA. NONSIGNIFICANT IMPROVEMENTS WERE SEEN IN MEASURES OF PAIN, FATIGUE, AND HOW ONE FELT IN THE MORNING. EFFECT SIZES WERE MEDIUM TO LARGE FOR MOST TESTED AREAS. THIS STUDY SUPPORTS THE BENEFITS OF YOGA AND MEDITATION FOR INDIVIDUALS WITH FIBROMYALGIA AND ENCOURAGES FURTHER RESEARCH TO EXPLORE THEIR USE AS STANDARD THERAPIES FOR FIBROMYALGIA. 2011 13 108 42 A PILOT RANDOMIZED CONTROLLED TRIAL OF THE YOGA OF AWARENESS PROGRAM IN THE MANAGEMENT OF FIBROMYALGIA. A MOUNTING BODY OF LITERATURE RECOMMENDS THAT TREATMENT FOR FIBROMYALGIA (FM) ENCOMPASS MEDICATIONS, EXERCISE AND IMPROVEMENT OF COPING SKILLS. HOWEVER, THERE IS A SIGNIFICANT GAP IN DETERMINING AN EFFECTIVE COUNTERPART TO PHARMACOTHERAPY THAT INCORPORATES BOTH EXERCISE AND COPING. THE AIM OF THIS RANDOMIZED CONTROLLED TRIAL WAS TO EVALUATE THE EFFECTS OF A COMPREHENSIVE YOGA INTERVENTION ON FM SYMPTOMS AND COPING. A SAMPLE OF 53 FEMALE FM PATIENTS WERE RANDOMIZED TO THE 8-WEEK YOGA OF AWARENESS PROGRAM (GENTLE POSES, MEDITATION, BREATHING EXERCISES, YOGA-BASED COPING INSTRUCTIONS, GROUP DISCUSSIONS) OR TO WAIT-LISTED STANDARD CARE. DATA WERE ANALYZED BY INTENTION TO TREAT. AT POST-TREATMENT, WOMEN ASSIGNED TO THE YOGA PROGRAM SHOWED SIGNIFICANTLY GREATER IMPROVEMENTS ON STANDARDIZED MEASURES OF FM SYMPTOMS AND FUNCTIONING, INCLUDING PAIN, FATIGUE, AND MOOD, AND IN PAIN CATASTROPHIZING, ACCEPTANCE, AND OTHER COPING STRATEGIES. THIS PILOT STUDY PROVIDES PROMISING SUPPORT FOR THE POTENTIAL BENEFITS OF A YOGA PROGRAM FOR WOMEN WITH FM. 2010 14 112 40 A PILOT STUDY OF A MINDFULNESS INFORMED YOGA INTERVENTION IN YOUNG PEOPLE WITH PSYCHOSIS. AIM: TO DETERMINE THE ACCEPTABILITY AND SAFETY OF A MINDFULNESS INFORMED YOGA INTERVENTION AS ADJUNCT TO USUAL CARE FOR YOUNG PEOPLE WITH EARLY PSYCHOSIS. METHODS: PEOPLE AGED 16-25 YEARS ATTENDING A COMMUNITY-BASED SPECIALIST EARLY PSYCHOSIS CLINIC WERE INVITED TO PARTICIPATE IN A 12-WEEK YOGA INTERVENTION. THE INTERVENTION CONSISTED OF 1-H WEEKLY CLASSES OF MINDFULNESS INFORMED YOGA. ACCEPTABILITY WAS MEASURED BY UPTAKE, ATTENDANCE AND PARTICIPANTS' SATISFACTION. SAFETY WAS MEASURED BY INCIDENCE OF PHYSICAL INJURY, PARTICIPANTS' LEVEL OF COMFORT, DISTRESS AND ANXIETY DURING THE SESSIONS, AND THE FOLLOWING MENTAL HEALTH OUTCOMES: POSITIVE AND NEGATIVE PSYCHOTIC, DEPRESSION, ANXIETY AND STRESS SYMPTOMS, SLEEP QUALITY AND FUNCTIONING. RESULTS: OF THOSE WHO CONSENTED TO THE STUDY, 80% (12) PARTICIPATED AND ON AVERAGE ATTENDED 4.4 YOGA CLASSES. THERE WERE NO PHYSICAL INJURIES AND PARTICIPANTS REPORTED MINIMAL DISTRESS AND ANXIETY. POST-INTERVENTION, THERE WAS A SIGNIFICANT REDUCTION IN ANXIETY SYMPTOMS AND AN IMPROVEMENT IN FUNCTION. CONCLUSIONS: MINDFULNESS-BASED YOGA INTERVENTIONS ARE BOTH ACCEPTABLE AND SAFE AS AN INTERVENTION FOR YOUTH WITH EARLY PSYCHOSIS. THOUGH NUMBERS WERE SMALL, THE STUDY SHOWS PROMISE FOR YOGA AS A POTENTIALLY USEFUL INTERVENTION. IMPORTANTLY, THERE WAS NO DETERIORATION IN MENTAL HEALTH OUTCOMES. A LARGER TRIAL EVALUATING CLINICAL EFFECTIVENESS IS NOW TIMELY. 2022 15 87 39 A MIXED METHODS EVALUATION OF AN INDIVIDUALISED YOGA THERAPY INTERVENTION FOR RHEUMATOID ARTHRITIS: PILOT STUDY. OBJECTIVES: TO EXPLORE PATIENTS' EXPERIENCES OF AN INDIVIDUALISED YOGA THERAPY INTERVENTION FOR RHEUMATOID ARTHRITIS (RA), SPECIFICALLY IN TERMS OF ITS ACCEPTABILITY AND IMPACT ON PATIENT-REPORTED OUTCOMES. DESIGN: TEN PATIENTS TOOK PART IN A 16 WEEK YOGA THERAPY INTERVENTION IN A HOSPITAL SETTING, CONSISTING OF 10 ONE-TO-ONE CONSULTATIONS WITH A YOGA THERAPIST FOLLOWED BY TWO GROUP REVIEW SESSIONS. CHANGES IN HEALTH (EQ-5D, HADS) WERE ASSESSED PRE- AND POST-INTERVENTION AND AT 12-MONTH FOLLOW-UP. IN-DEPTH INTERVIEWS WERE CONDUCTED POST-INTERVENTION AND ANALYSED USING THEMATIC ANALYSIS. RESULTS: ATTENDANCE OF THE 1-TO-1 SESSIONS WAS HIGH (98 %) AND ALL PARTICIPANTS REPORTED STRONG COMMITMENT TO THEIR PERSONALISED HOME PRACTICE. THERE WERE SIGNIFICANT IMPROVEMENTS IN MEASURES OF DEPRESSION, ANXIETY, PAIN, QUALITY OF LIFE AND GENERAL HEALTH AT POST-INTERVENTION AND 12-MONTHS (P < 0.05). IN INTERVIEWS, ALL BUT ONE PARTICIPANT REPORTED POSITIVE CHANGES TO THEIR SYMPTOMS AND SEVERAL REPORTED REDUCTIONS IN THEIR MEDICATION AND BROADER BENEFITS SUCH AS IMPROVED SLEEP, MOOD AND ENERGY, ENABLING RE-ENGAGEMENT WITH LIFE. THE PERSONALLY TAILORED NATURE OF THE PRACTICE AND PERCEIVED BENEFITS WERE KEY MOTIVATIONAL FACTORS. PARTICULAR VALUE WAS PLACED ON THE THERAPEUTIC FUNCTION OF THE CONSULTATION AND PROVISION OF TOOLS TO MANAGE STRESS AND BUILD RESILIENCE. CONCLUSION: THIS YOGA THERAPY INTERVENTION WAS POSITIVELY RECEIVED BY PATIENTS WITH RA, WITH HIGH LEVELS OF ADHERENCE TO BOTH THE TREATMENTS AND TAILORED HOME PRACTICE. THE FINDINGS SUGGEST THAT YOGA THERAPY HAS POTENTIAL AS AN ADJUNCT THERAPY TO IMPROVE RA SYMPTOMS, INCREASE SELF-CARE BEHAVIOURS AND MANAGE STRESS AND NEGATIVE AFFECT SUCH AS ANXIETY. A LARGER MULTI-CENTRE STUDY IS THEREFORE WARRANTED. 2020 16 14 48 "NOW I SEE A BRIGHTER DAY": EXPECTATIONS AND PERCEIVED BENEFITS OF AN IYENGAR YOGA INTERVENTION FOR YOUNG PATIENTS WITH RHEUMATOID ARTHRITIS. RHEUMATOID ARTHRITIS (RA) IS A CHRONIC DISEASE CHARACTERIZED BY INFLAMMATION OF JOINTS AND ASSOCIATED FATIGUE, DETERIORATED RANGE OF MOTION, AND IMPAIRED PSYCHOSOCIAL FUNCTIONING. YOUNG ADULTS WITH RA ARE AT A PARTICULAR RISK FOR COMPROMISED HEALTH-RELATED QUALITY OF LIFE, AND THERE IS A NEED FOR SAFE, EFFECTIVE COMPLEMENTARY TREATMENT IN ADDITION TO TRADITIONAL MEDICAL APPROACHES. THE AIM OF THE PRESENT STUDY WAS TO USE FACE-TO-FACE PARTICIPANT INTERVIEWS, CONDUCTED BEFORE AND AFTER AN IYENGAR YOGA (IY) PROGRAM, TO EXAMINE MECHANISMS THROUGH WHICH YOGA MAY BE BENEFICIAL TO YOUNG ADULTS WITH RA.THIS PILOT STUDY UTILIZED A SINGLE-ARM DESIGN WHERE ALL PARTICIPANTS RECEIVED THE INTERVENTION. CLASSES WERE TAUGHT TWICE PER WEEK (1.5 HOURS EACH) FOR 6 WEEKS BY AN IY TEACHER QUALIFIED IN THERAPEUTICS. INTERVIEW THEMES INCLUDED PARTICIPANTS' BASELINE EXPECTATIONS ABOUT YOGA AND VIEWPOINTS AS TO HOW THEIR FUNCTIONING HAD BEEN IMPACTED BY THE IY INTERVENTION WERE EXAMINED. FIVE YOUNG ADULTS WITH RA AGED 24-31 YEARS (MEAN = 28; 80% FEMALE) COMPLETED THE YOGA INTERVENTION. PARTICIPANTS CONSISTENTLY REPORTED THAT YOGA HELPED WITH ENERGY, RELAXATION AND MOOD AND THEY DISCUSSED PERCEIVED MECHANISMS FOR HOW YOGA IMPACTED WELL-BEING. MECHANISMS INCLUDED PHYSICAL CHANGES SUCH AS RANGE OF MOTION AND PHYSIOLOGICAL AWARENESS, AND PSYCHOSPIRITUAL DEVELOPMENTS SUCH AS ACCEPTANCE, COPING, SELF-EFFICACY AND MINDFULNESS. THOUGH THE STUDY IS LIMITED, PARTICIPANTS' RESPONSES PROVIDE COMPELLING EVIDENCE THAT IY FOR RA PATIENTS IS AN INTERVENTION WORTHY OF FURTHER EXPLORATION. THE MECHANISMS AND OUTCOMES REPORTED BY PARTICIPANTS SUPPORT A BIOPSYCHOSOCIAL MODEL, WHICH PROPOSES THAT YOGA BENEFITS PATIENTS THROUGH BOTH PHYSIOLOGICAL AND PSYCHOSPIRITUAL CHANGES. 2011 17 2383 30 YOGA & CANCER INTERVENTIONS: A REVIEW OF THE CLINICAL SIGNIFICANCE OF PATIENT REPORTED OUTCOMES FOR CANCER SURVIVORS. LIMITED RESEARCH SUGGESTS YOGA MAY BE A VIABLE GENTLE PHYSICAL ACTIVITY OPTION WITH A VARIETY OF HEALTH-RELATED QUALITY OF LIFE, PSYCHOSOCIAL AND SYMPTOM MANAGEMENT BENEFITS. THE PURPOSE OF THIS REVIEW WAS TO DETERMINE THE CLINICAL SIGNIFICANCE OF PATIENT-REPORTED OUTCOMES FROM YOGA INTERVENTIONS CONDUCTED WITH CANCER SURVIVORS. A TOTAL OF 25 PUBLISHED YOGA INTERVENTION STUDIES FOR CANCER SURVIVORS FROM 2004-2011 HAD PATIENT-REPORTED OUTCOMES, INCLUDING QUALITY OF LIFE, PSYCHOSOCIAL OR SYMPTOM MEASURES. THIRTEEN OF THESE STUDIES MET THE NECESSARY CRITERIA TO ASSESS CLINICAL SIGNIFICANCE. CLINICAL SIGNIFICANCE FOR EACH OF THE OUTCOMES OF INTEREST WAS EXAMINED BASED ON 1 STANDARD ERROR OF THE MEASUREMENT, 0.5 STANDARD DEVIATION, AND RELATIVE COMPARATIVE EFFECT SIZES AND THEIR RESPECTIVE CONFIDENCE INTERVALS. THIS REVIEW DESCRIBES IN DETAIL THESE PATIENT-REPORTED OUTCOMES, HOW THEY WERE OBTAINED, THEIR RELATIVE CLINICAL SIGNIFICANCE AND IMPLICATIONS FOR BOTH CLINICAL AND RESEARCH SETTINGS. OVERALL, CLINICALLY SIGNIFICANT CHANGES IN PATIENT-REPORTED OUTCOMES SUGGEST THAT YOGA INTERVENTIONS HOLD PROMISE FOR IMPROVING CANCER SURVIVORS' WELL-BEING. THIS RESEARCH OVERVIEW PROVIDES NEW DIRECTIONS FOR EXAMINING HOW CLINICAL SIGNIFICANCE CAN PROVIDE A UNIQUE CONTEXT FOR DESCRIBING CHANGES IN PATIENT-REPORTED OUTCOMES FROM YOGA INTERVENTIONS. RESEARCHERS ARE ENCOURAGED TO EMPLOY INDICES OF CLINICAL SIGNIFICANCE IN THE INTERPRETATION AND DISCUSSION OF RESULTS FROM YOGA STUDIES. 2012 18 2284 32 THE USE OF YOGA AS A GROUP INTERVENTION FOR PEDIATRIC CHRONIC PAIN REHABILITATION: EXPLORING QUALITATIVE AND QUANTITATIVE OUTCOMES. PURPOSE: WITH THE INCREASE IN OPIOID USE OVER THE LAST DECADE, MIND-BODY APPROACHES TO PEDIATRIC PAIN MANAGEMENT HAVE BEEN TRENDING. TO DATE, THERE IS LIMITED RESEARCH REGARDING THE USE OF YOGA WITH PEDIATRIC CHRONIC PAIN. THIS STUDY AIMS TO GAUGE THE EFFECTIVENESS OF GROUP YOGA AS PART OF CHRONIC PAIN REHABILITATION AND ONE'S ABILITY TO CONTINUE PRACTICING INDEPENDENTLY BY EXPLORING QUALITATIVE AND QUANTITATIVE INFORMATION. METHODS: A SINGLE THERAPIST USED YOGA AS A GROUP PHYSICAL THERAPY INTERVENTION ONCE A WEEK FOR 60 MINUTES. YOGA EDUCATION, IYENGAR YOGA COMPONENTS, RELAXATION, AND STRETCHING WERE INCORPORATED INTO THE THERAPEUTIC YOGA SESSION. QUALITATIVE AND QUANTITATIVE INFORMATION WAS COLLECTED. RESULTS: QUALITATIVE OUTCOMES PROVIDED VALUABLE DATA ABOUT DISTRACTIONS AND BENEFITS. QUANTITATIVE OUTCOMES SHOWED THAT THERE WERE SIGNIFICANT IMPROVEMENTS IN AREAS SUCH AS MENTAL TENSION, EMOTIONAL TENSION, MUSCLE TENSION, AND PAIN (ALL P < 0.001 SIGNIFICANT). CONCLUSION: PEDIATRIC CHRONIC PAIN PATIENTS CAN IDENTIFY MANY BENEFITS AFTER A SINGLE GROUP YOGA SESSION. IT COMBINES THE PHYSICAL AND COGNITIVE ASPECTS OF INTERDISCIPLINARY PAIN REHABILITATION FOR CONTINUED USE AFTER DISCHARGE. THE USE OF YOGA IS AN ECONOMICAL MEANS OF PHYSICAL ACTIVITY AFTER DISCHARGE TO PROMOTE LONG-TERM BENEFITS. 2020 19 1684 30 OPEN TRIAL OF VINYASA YOGA FOR PERSISTENTLY DEPRESSED INDIVIDUALS: EVIDENCE OF FEASIBILITY AND ACCEPTABILITY. THE AIM OF THIS STUDY WAS TO ASSESS THE ACCEPTABILITY AND FEASIBILITY OF VINYASA YOGA AS AN ADJUNCTIVE TREATMENT FOR DEPRESSED PATIENTS WHO WERE NOT RESPONDING ADEQUATELY TO ANTIDEPRESSANT MEDICATION. THE AUTHORS ALSO PLANNED TO ASK PARTICIPANTS FOR QUALITATIVE FEEDBACK ON THEIR EXPERIENCE OF THE CLASS AND TO ASSESS CHANGE OVER TIME IN DEPRESSION AND IN POSSIBLE MEDIATING VARIABLES. THE AUTHORS RECRUITED 11 PARTICIPANTS IN 1 MONTH FOR AN 8-WEEK OPEN TRIAL OF YOGA CLASSES. THEY FOUND THAT 10 PARTICIPANTS COMPLETED FOLLOW-UP ASSESSMENTS, 9 OF 10 WERE POSITIVE ABOUT THEIR EXPERIENCE, AND ALL PROVIDED FEEDBACK ABOUT WHAT WAS AND WAS NOT HELPFUL ABOUT YOGA, AS WELL AS BARRIERS TO CLASS ATTENDANCE. OVER THE 2-MONTH PERIOD, PARTICIPANTS EXHIBITED SIGNIFICANT DECREASES IN DEPRESSION SYMPTOMS AND SIGNIFICANT INCREASES IN AN ASPECT OF MINDFULNESS AND IN BEHAVIOR ACTIVATION. THIS PILOT STUDY PROVIDED SUPPORT FOR CONTINUING TO INVESTIGATE VINYASA YOGA AS AN ADJUNCT TREATMENT FOR DEPRESSION. THE NEXT STEP REQUIRED IS A RIGOROUS RANDOMIZED CLINICAL TRIAL. 2010 20 1617 56 MINDFUL YOGA FOR WOMEN WITH METASTATIC BREAST CANCER: DESIGN OF A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: WOMEN WITH METASTATIC BREAST CANCER (MBC) HAVE AVERAGE LIFE EXPECTANCIES OF ABOUT 2 YEARS, AND REPORT HIGH LEVELS OF DISEASE-RELATED SYMPTOMS INCLUDING PAIN, FATIGUE, SLEEP DISTURBANCE, PSYCHOLOGICAL DISTRESS, AND FUNCTIONAL IMPAIRMENT. THERE IS GROWING RECOGNITION OF THE LIMITATIONS OF MEDICAL APPROACHES TO MANAGING SUCH SYMPTOMS. YOGA IS A MIND-BODY DISCIPLINE THAT HAS DEMONSTRATED A POSITIVE IMPACT ON PSYCHOLOGICAL AND FUNCTIONAL HEALTH IN EARLY STAGE BREAST CANCER PATIENTS AND SURVIVORS, BUT HAS NOT BEEN RIGOROUSLY STUDIED IN ADVANCED CANCER SAMPLES. METHODS: THIS RANDOMIZED CONTROLLED TRIAL EXAMINES THE FEASIBILITY AND INITIAL EFFICACY OF A MINDFUL YOGA PROGRAM, COMPARED WITH A SOCIAL SUPPORT CONDITION THAT CONTROLS FOR ATTENTION, ON MEASURES OF DISEASE-RELATED SYMPTOMS SUCH AS PAIN AND FATIGUE. THE STUDY WILL BE COMPLETED BY DECEMBER 2017. SIXTY-FIVE WOMEN WITH MBC AGE >/= 18 ARE BEING IDENTIFIED AND RANDOMIZED WITH A 2:1 ALLOCATION TO MINDFUL YOGA OR A SUPPORT GROUP CONTROL INTERVENTION. THE 120-MIN INTERVENTION SESSIONS TAKE PLACE WEEKLY FOR 8 WEEKS. THE STUDY IS CONDUCTED AT AN URBAN TERTIARY CARE ACADEMIC MEDICAL CENTER LOCATED IN DURHAM, NORTH CAROLINA. THE PRIMARY FEASIBILITY OUTCOME IS ATTENDANCE AT INTERVENTION SESSIONS. EFFICACY OUTCOMES INCLUDE PAIN, FATIGUE, SLEEP QUALITY, PSYCHOLOGICAL DISTRESS, MINDFULNESS AND FUNCTIONAL CAPACITY AT POST-INTERVENTION, 3-MONTH FOLLOW-UP, AND 6-MONTH FOLLOW-UP. DISCUSSION: IN THIS ARTICLE, WE PRESENT THE CHALLENGES OF DESIGNING A RANDOMIZED CONTROLLED TRIAL WITH LONG-TERM FOLLOW-UP AMONG WOMEN WITH MBC. THESE CHALLENGES INCLUDE ENSURING ADEQUATE RECRUITMENT INCLUDING OF MINORITIES, LIMITING AND CONTROLLING FOR SELECTION BIAS, TAILORING OF THE YOGA INTERVENTION TO ADDRESS SPECIAL NEEDS, AND MAXIMIZING ADHERENCE AND RETENTION. THIS PROJECT WILL PROVIDE IMPORTANT INFORMATION REGARDING YOGA AS AN INTERVENTION FOR WOMEN WITH ADVANCED CANCER, INCLUDING PRELIMINARY DATA ON THE PSYCHOLOGICAL AND FUNCTIONAL EFFECTS OF YOGA FOR MBC PATIENTS. THIS INVESTIGATION WILL ALSO ESTABLISH RIGOROUS METHODS FOR FUTURE RESEARCH INTO YOGA AS AN INTERVENTION FOR THIS POPULATION. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFER: NCT01927081 , REGISTERED AUGUST 16, 2013. 2017