1 346 75 ASSESSING FIDELITY OF CORE COMPONENTS IN A MINDFULNESS AND YOGA INTERVENTION FOR URBAN YOUTH: APPLYING THE CORE PROCESS. IN THE PAST YEARS, THE NUMBER OF MINDFULNESS-BASED INTERVENTION AND PREVENTION PROGRAMS HAS INCREASED STEADILY. IN ORDER TO ACHIEVE THE INTENDED PROGRAM OUTCOMES, PROGRAM IMPLEMENTERS NEED TO UNDERSTAND THE ESSENTIAL AND INDISPENSABLE COMPONENTS THAT DEFINE A PROGRAM'S SUCCESS. THIS CHAPTER DESCRIBES THE COMPLEX PROCESS OF IDENTIFYING THE CORE COMPONENTS OF A MINDFULNESS AND YOGA PROGRAM FOR URBAN EARLY ADOLESCENTS THROUGH THE SYSTEMATIC STUDY OF FIDELITY OF IMPLEMENTATION OF THE INTERVENTION. THE AUTHORS ILLUSTRATE THE CORE PROCESS [(C) CONCEPTUALIZE CORE COMPONENTS; (O) OPERATIONALIZE AND MEASURE; (R) RUN ANALYSES AND REVIEW IMPLEMENTATION FINDINGS; AND (E) ENHANCE AND REFINE], BASED ON DATA GAINED FROM A MINDFULNESS AND YOGA INTERVENTION STUDY CONDUCTED AS A COMMUNITY-ACADEMIC PARTNERSHIP IN BALTIMORE CITY. 2014 2 446 18 CHALLENGES OF IMPLEMENTING MULTICENTER STUDIES OF YOGA FOR PEDIATRIC CANCER AND HEMATOPOIETIC STEM CELL TRANSPLANTATION RECIPIENTS. THE PRIMARY OBJECTIVE OF THIS WORK WAS TO DETERMINE THE FEASIBILITY OF A RANDOMIZED TRIAL OF INDIVIDUALIZED YOGA FOR CHILDREN RECEIVING INTENSIVE CHEMOTHERAPY AND FOR HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT) RECIPIENTS OUTSIDE OF THE PRINCIPAL COORDINATING INSTITUTION. WE EVALUATED THE FEASIBILITY OF A RANDOMIZED TRIAL OF INDIVIDUALIZED YOGA VERSUS AN IPAD CONTROL PROGRAM AT A SITE WHERE EXTERNAL YOGA INSTRUCTORS WERE HIRED AND COMPENSATED PER SESSION. SUBJECTS WERE CHILDREN RECEIVING INTENSIVE CHEMOTHERAPY FOR HEMATOLOGICAL MALIGNANCIES AND AUTOLOGOUS OR ALLOGENEIC HSCT RECIPIENTS EXPECTED TO BE HOSPITALIZED FOR 3 WEEKS. YOGA OR IPAD CONTROL CONTACT OCCURRED DAILY FOR 21 DAYS (EXCLUDING WEEKENDS AND HOLIDAYS); FATIGUE AND QUALITY-OF-LIFE OUTCOMES WERE MEASURED AT BASELINE, DAY 10, AND DAY 21. TEN ELIGIBLE SUBJECTS WERE IDENTIFIED; SIX SUBJECTS CONSENTED AND WERE ENROLLED. THREE WERE RANDOMIZED TO THE INDIVIDUALIZED YOGA INTERVENTION AND THREE TO THE IPAD CONTROL PROGRAM. THE MEDIAN AGE OF PARTICIPANTS WAS 12 (RANGE 8-15) YEARS, AND 2 (33%) WERE BOYS. CHALLENGES PRIMARILY RELATED TO THE HIRING OF YOGA INSTRUCTORS WHO WERE NOT TRAINED IN RESEARCH METHODS. WE FOUND ISSUES WITH: (1) LOGISTICS OF HIRING, TRAINING, AND RETAINING INSTRUCTORS; (2) COMMUNICATION BETWEEN TEAMS; (3) FIDELITY TO THE PROTOCOL AND OUTCOME ASSESSMENTS; AND (4) ENSURING SAFETY. WE FOUND THAT A RANDOMIZED TRIAL OF INDIVIDUALIZED YOGA PRESENTED NEW CHALLENGES WHEN RELYING ON EXTERNALLY CONTRACTED YOGA INSTRUCTORS. FUTURE MULTICENTER STUDIES OF YOGA SHOULD SEEK TO BETTER INTEGRATE PRACTITIONERS WITHIN THE RESEARCH TEAM TO IMPROVE PROCESSES, COMMUNICATION, FIDELITY TO THE PROTOCOL, AND SAFETY. 2021 3 1156 22 ENSURING YOGA INTERVENTION FIDELITY IN A RANDOMIZED PREFERENCE TRIAL FOR THE TREATMENT OF WORRY IN OLDER ADULTS. INTRODUCTION: YOGA FOR TREATMENT OF WORRY IN OLDER ADULTS IS AN INTERVENTION THAT IS ESPECIALLY LIKELY TO TRANSLATE INTO REAL-WORLD PRACTICE. ASSESSING TREATMENT FIDELITY IMPROVES CONFIDENCE THAT EFFECTIVE INTERVENTIONS CAN BE CONSISTENTLY APPLIED AND ALLOWS RESEARCHERS TO EXPLORE IF ANY NULL RESULTS FOR EFFECTIVENESS ARE INDEED THE RESULT OF A LACK OF INTERVENTION EFFICACY OR LACK OF PROPER INTERVENTION IMPLEMENTATION. METHODS: THIS STUDY DESCRIBES TREATMENT FIDELITY OF A YOGA INTERVENTION IN A RANDOMIZED PREFERENCE TRIAL THAT COMPARED COGNITIVE-BEHAVIORAL THERAPY (CBT) AND YOGA FOR THE TREATMENT OF WORRY, ANXIETY, AND SLEEP IN WORRIED OLDER (>/=60 YEARS) ADULTS. ESTABLISHED METHODS FOR ASSESSING TREATMENT FIDELITY OF CBT GUIDED THE PROCEDURE FOR ENSURING THAT THE YOGA INTERVENTION WAS DELIVERED AS INTENDED. THE YOGA INTERVENTION CONSISTED OF 20, 75-MIN, IN-PERSON, GROUP, GENTLE YOGA CLASSES HELD TWICE WEEKLY. RESULTS: SIX FEMALE INSTRUCTORS (MEAN AGE = 64 YEARS) TAUGHT 660 YOGA CLASSES THAT WERE VIDEOTAPED. TEN PERCENT OF THESE CLASSES, STRATIFIED BY INSTRUCTOR, WERE RANDOMLY SELECTED FOR REVIEW. THE AVERAGE ADHERENCE SCORE FOR YOGA INSTRUCTORS WAS 6.84 (RANGE 4-8). THE AVERAGE COMPETENCY SCORES WERE CONSISTENTLY HIGH, WITH AN AVERAGE SCORE OF 7.24 (RANGE 6-8). TEACHING CONTENT NOT INCLUDED IN THE PROTOCOL OCCURRED IN 26 (38.1%) SESSIONS AND DECREASED OVER TIME. OBSERVED RATINGS OF INSTRUCTOR ADHERENCE WERE SIGNIFICANTLY RELATED TO RATINGS OF COMPETENCY. INSTRUCTOR ADHERENCE WAS ALSO SIGNIFICANTLY ASSOCIATED WITH LOWER PARTICIPANT ATTENDANCE, BUT NOT WITH ANY OF THE OTHER PROCESS OR OUTCOME MEASURES. CONCLUSIONS: THE LARGER RANGE FOUND IN ADHERENCE RELATIVE TO COMPETENCE SCORES DEMONSTRATED THAT TEACHING A YOGA CLASS ACCORDING TO A PROTOCOL REQUIRES DIFFERENT SKILLS THAN COMPETENTLY TEACHING A YOGA CLASS IN THE COMMUNITY, AND THESE SKILLS IMPROVED WITH FEEDBACK. THESE RESULTS MAY FOSTER DIALOG BETWEEN THE YOGA RESEARCH AND PRACTICE COMMUNITIES. CLINICAL TRIAL REGISTRATION NO.: NCT02968238. 2021 4 109 18 A PILOT STUDY ASSESSING ACCEPTABILITY AND FEASIBILITY OF HATHA YOGA FOR CHRONIC PAIN IN PEOPLE RECEIVING OPIOID AGONIST THERAPY FOR OPIOID USE DISORDER. THE PURPOSE OF THIS PROJECT WAS TO ASSESS THE FEASIBILITY AND ACCEPTABILITY OF A HATHA YOGA PROGRAM DESIGNED TO TARGET CHRONIC PAIN IN PEOPLE RECEIVING OPIOID AGONIST THERAPY FOR OPIOID USE DISORDER. WE CONDUCTED A PILOT RANDOMIZED TRIAL IN WHICH PEOPLE WITH CHRONIC PAIN WHO WERE RECEIVING EITHER METHADONE MAINTENANCE THERAPY (N=20) OR BUPRENORPHINE (N=20) WERE RANDOMLY ASSIGNED TO WEEKLY HATHA YOGA OR HEALTH EDUCATION (HE) CLASSES FOR 3MONTHS. WE DEMONSTRATED FEASIBILITY IN MANY DOMAINS, INCLUDING RECRUITMENT OF PARTICIPANTS (58% FEMALE, MEAN AGE 43), RETENTION FOR FOLLOW-UP ASSESSMENTS, AND ABILITY OF TEACHERS TO PROVIDE INTERVENTIONS WITH HIGH FIDELITY TO THE MANUALS. FIFTY PERCENT OF PARTICIPANTS IN YOGA (95% CI: 0.28-0.72) AND 65% OF PARTICIPANTS IN HE (95% CI: 0.44-0.87) ATTENDED AT LEAST 6 OF 12 POSSIBLE CLASSES (P=0.62). SIXTY-ONE PERCENT IN THE YOGA GROUP REPORTED PRACTICING YOGA AT HOME, WITH A MEAN NUMBER OF TIMES PRACTICING PER WEEK OF 2.67 (SD=2.37). PARTICIPANT MOOD IMPROVED PRE-CLASS TO POST-CLASS, WITH GREATER DECREASES IN ANXIETY AND PAIN FOR THOSE IN THE YOGA GROUP (P<0.05). IN CONCLUSION, YOGA CAN BE DELIVERED ON-SITE AT OPIOID AGONIST TREATMENT PROGRAMS WITH HOME PRACTICE TAKEN UP BY THE MAJORITY OF PARTICIPANTS. FUTURE RESEARCH MAY EXPLORE WAYS OF INCREASING THE YOGA "DOSAGE" RECEIVED. THIS MAY INVOLVE TESTING STRATEGIES FOR INCREASING EITHER CLASS ATTENDANCE OR THE AMOUNT OF HOME PRACTICE OR BOTH. 2019 5 1495 15 INTERVENTION PROTOCOL FOR INVESTIGATING YOGA IMPLEMENTED DURING CHEMOTHERAPY. OBJECTIVE: FATIGUE AND OTHER TREATMENT-RELATED SYMPTOMS ARE CRITICAL THERAPEUTIC TARGETS FOR IMPROVING QUALITY OF LIFE IN PATIENTS WITH COLORECTAL CANCER DURING CHEMOTHERAPY. YOGA IS A PROMISING INTERVENTION FOR IMPROVING THESE THERAPEUTIC TARGETS AND HAS BEEN PRIMARILY INVESTIGATED IN THE GROUP-CLASS FORMAT, WHICH IS LESS FEASIBLE FOR CANCER PATIENTS WITH HIGH SYMPTOM BURDEN TO ATTEND. THUS, WE DEVELOPED A PROTOCOL FOR IMPLEMENTING YOGA INDIVIDUALLY IN THE CLINIC AMONG PATIENTS RECEIVING CHEMOTHERAPY. METHODS: WE FOLLOWED RECOMMENDED DOMAINS FOR DEVELOPING A YOGA PROTOCOL TO BE USED IN AN EFFICACY TRIAL. THESE RECOMMENDATIONS INCLUDE CONSIDERATION TO THE STYLE, DELIVERY, COMPONENTS OF THE INTERVENTION, DOSE, SPECIFIC CLASS SEQUENCES, FACILITATION OF HOME PRACTICE, MEASUREMENT OF INTERVENTION FIDELITY, SELECTION OF INSTRUCTORS, AND DEALING WITH MODIFICATIONS. THE INTERVENTION PROTOCOL WAS DEVELOPED BY AN INTERDISCIPLINARY TEAM. PROTOCOL: YOGA SKILLS TRAINING (YST) CONSISTS OF FOUR 30-MINUTE IN-PERSON SESSIONS AND WAS IMPLEMENTED WHILE IN THE CHAIR DURING CHEMOTHERAPY INFUSIONS FOR COLORECTAL CANCER WITH RECOMMENDED DAILY HOME PRACTICE FOR EIGHT WEEKS. THERAPEUTIC GOALS OF THE YST ARE TO REDUCE FATIGUE, CIRCADIAN DISRUPTION, AND PSYCHOLOGICAL DISTRESS. ELEMENTS OF THE YST ARE AWARENESS MEDITATION, GENTLE SEATED MOVEMENT, BREATHING PRACTICE, AND RELAXATION MEDITATION. ATTENTION, COMFORT, AND EASE ARE ALSO HIGHLIGHTED. CONCLUSION: THIS DESCRIPTION OF A PROTOCOL FOR INTEGRATING YOGA WITH CONVENTIONAL CANCER TREATMENT WILL INFORM FUTURE STUDY DESIGNS AND CLINICAL PRACTICE. THE DESIGN OF THE YST IS NOVEL BECAUSE IT IMPLEMENTS YOGA-MOST COMMONLY STUDIED WHEN TAUGHT TO GROUPS OUTSIDE OF THE CLINICAL SETTING- INDIVIDUALLY DURING CLINICAL CARE. 2016 6 375 22 BARRIERS AND FACILITATORS TO IMPLEMENTING BUNDLED ACUPUNCTURE AND YOGA THERAPY TO TREAT CHRONIC PAIN IN COMMUNITY HEALTHCARE SETTINGS: A FEASIBILITY PILOT. OBJECTIVE: TO IDENTIFY FACTORS ASSOCIATED WITH IMPLEMENTING BUNDLED GROUP ACUPUNCTURE AND YOGA THERAPY (YT) TO TREAT UNDERSERVED PATIENTS WITH CHRONIC PAIN IN COMMUNITY HEALTH CENTER (CHC) SETTINGS. THIS IS NOT AN IMPLEMENTATION SCIENCE STUDY, BUT RATHER AN ORGANIZED APPROACH FOR IDENTIFICATION OF BARRIERS AND FACILITATORS TO IMPLEMENTING THESE THERAPIES AS A PRECURSOR TO A FUTURE IMPLEMENTATION SCIENCE STUDY. DESIGN: THIS STUDY WAS PART OF A SINGLE-ARM FEASIBILITY TRIAL, WHICH AIMED TO TEST THE FEASIBILITY OF BUNDLING GA AND YT FOR CHRONIC PAIN IN CHCS. TREATMENT OUTCOMES WERE MEASURED BEFORE AND AFTER THE 10-WEEK INTERVENTION PERIOD. IMPLEMENTATION FEASIBILITY WAS ASSESSED THROUGH WEEKLY RESEARCH TEAM MEETINGS, WEEKLY YOGA PROVIDER MEETINGS, MONTHLY ACUPUNCTURE PROVIDER MEETINGS, AND WEEKLY PROVIDER SURVEYS. SETTINGS: THE STUDY WAS CONDUCTED IN NEW YORK CITY AT TWO MONTEFIORE MEDICAL GROUP (MMG) SITES IN THE BRONX, AND ONE INSTITUTE FOR FAMILY HEALTH (IFH) SITE IN HARLEM. SUBJECTS: PARTICIPANTS IN THE FEASIBILITY TRIAL WERE RECRUITED FROM IFH AND MMG SITES, AND NEEDED TO HAVE HAD LOWER BACK, NECK, OR OSTEOARTHRITIS PAIN FOR >3 MONTHS. IMPLEMENTATION STAKEHOLDERS INCLUDED THE RESEARCH TEAM, PROVIDERS OF ACUPUNCTURE AND YT, REFERRING PROVIDERS, AND CHC STAFF. RESULTS: IMPLEMENTATION OF THESE THERAPIES WAS ASSESSED USING THE CONSOLIDATED FRAMEWORK FOR IMPLEMENTATION RESEARCH. WE IDENTIFIED ISSUES ASSOCIATED WITH SCHEDULING, TREATMENT FIDELITY, COMMUNICATION, THE THREE-WAY DISCIPLINARY INTERACTION OF ACUPUNCTURE, YOGA, AND BIOMEDICINE, SPACE ADAPTATION, SITE-SPECIFIC LOGISTICAL AND OPERATIONAL REQUIREMENTS, AND PATIENT-PROVIDER LANGUAGE BARRIERS. ISSUES VARIED AS TO THEIR FREQUENCY AND RESOLUTION DIFFICULTY. CONCLUSIONS: THIS FEASIBILITY TRIAL IDENTIFIED IMPLEMENTATION ISSUES AND RESOLUTION STRATEGIES THAT COULD BE FURTHER EXPLORED IN FUTURE IMPLEMENTATION STUDIES. CLINICAL TRIAL REGISTRATION NO.: NCT04296344. 2021 7 148 21 A QUALITATIVE EXPLORATION OF IMPLEMENTATION FACTORS IN A SCHOOL-BASED MINDFULNESS AND YOGA PROGRAM: LESSONS LEARNED FROM STUDENTS AND TEACHERS. IDENTIFYING FACTORS RELEVANT FOR SUCCESSFUL IMPLEMENTATION OF SCHOOL-BASED INTERVENTIONS IS ESSENTIAL TO ENSURE THAT PROGRAMS ARE PROVIDED IN AN EFFECTIVE AND ENGAGING MANNER. THE PERSPECTIVES OF TWO KEY STAKEHOLDERS CRITICAL FOR IDENTIFYING IMPLEMENTATION BARRIERS AND FACILITATORS - STUDENTS AND THEIR CLASSROOM TEACHERS - MERIT ATTENTION IN THIS CONTEXT AND HAVE RARELY BEEN EXPLORED USING QUALITATIVE METHODS. THIS STUDY REPORTS QUALITATIVE PERSPECTIVES OF FIFTH AND SIXTH GRADE PARTICIPANTS AND THEIR TEACHERS OF A 16-WEEK SCHOOL-BASED MINDFULNESS AND YOGA PROGRAM IN THREE PUBLIC SCHOOLS SERVING LOW-INCOME URBAN COMMUNITIES. FOUR THEMES RELATED TO PROGRAM IMPLEMENTATION BARRIERS AND FACILITATORS EMERGED: PROGRAM DELIVERY FACTORS, PROGRAM BUY-IN, IMPLEMENTER COMMUNICATION WITH TEACHERS, AND INSTRUCTOR QUALITIES. FEEDBACK FROM STUDENTS AND TEACHERS IS DISCUSSED IN THE CONTEXT OF INFORMING IMPLEMENTATION, ADAPTATION, AND FUTURE DEVELOPMENT OF SCHOOL-BASED MINDFULNESS AND YOGA PROGRAMMING IN URBAN SETTINGS. 2017 8 2039 21 TESTING THE EFFICACY OF YOGA AS A COMPLEMENTARY THERAPY FOR SMOKING CESSATION: DESIGN AND METHODS OF THE BREATHEASY TRIAL. INTRODUCTION: SMOKERS TRYING TO QUIT ENCOUNTER MANY CHALLENGES INCLUDING NICOTINE WITHDRAWAL SYMPTOMS, CIGARETTE CRAVING, INCREASED STRESS AND NEGATIVE MOOD AND CONCERN REGARDING WEIGHT GAIN. THESE PHENOMENA MAKE IT DIFFICULT TO SUCCESSFULLY QUIT SMOKING. STUDIES IN NON-SMOKING POPULATIONS SHOW THAT YOGA REDUCES STRESS AND NEGATIVE MOOD AND IMPROVES WEIGHT CONTROL. BY INCREASING MINDFULNESS WE ANTICIPATE THAT YOGA MAY ALSO IMPROVE SMOKERS' ABILITY TO COPE WITH THE NEGATIVE SYMPTOMS ASSOCIATED WITH QUITTING. YOGA MAY ALSO IMPROVE COGNITIVE DELIBERATION WHICH IS NEEDED TO MAKE EFFECTIVE CHOICES AND AVOID SMOKING IN TEMPTING SITUATIONS. METHODS/DESIGN: THE BREATHEASY STUDY IS A RIGOROUS, RANDOMIZED CONTROLLED CLINICAL TRIAL EXAMINING THE EFFICACY OF IYENGAR YOGA AS A COMPLEMENTARY THERAPY TO COGNITIVE-BEHAVIORAL THERAPY FOR SMOKING CESSATION. ALL PARTICIPANTS ARE GIVEN AN 8-WEEK PROGRAM OF SMOKING CESSATION CLASSES, AND ARE RANDOMIZED TO EITHER TWICE WEEKLY YOGA (YOGA) OR TWICE-WEEKLY HEALTH AND WELLNESS CLASSES WHICH SERVE AS A CONTROL FOR CONTACT AND PARTICIPANT BURDEN (CTL). ASSESSMENTS ARE CONDUCTED AT BASELINE, 8 WEEKS, 3, 6, AND 12 MONTHS OF FOLLOW-UP. THE PRIMARY OUTCOME IS PROLONGED ABSTINENCE USING AN INTENTION-TO-TREAT APPROACH. MULTIPLE INTERNAL AND EXTERNAL AUDITS USING BLIND DATA COLLECTION ARE EMPLOYED TO ENSURE TREATMENT FIDELITY AND RELIABILITY OF STUDY RESULTS. TO UNDERSTAND WHY YOGA MAY BE MORE EFFECTIVE THAN CTL, WE WILL EXAMINE THE MECHANISMS OF ACTION (I.E., MEDIATORS) UNDERLYING INTERVENTION EFFICACY. WE WILL EXAMINE THE MAINTENANCE OF YOGA PRACTICE AND SMOKING STATUS AT EACH FOLLOW-UP. FOCUS GROUPS AND INTERVIEWS WILL BE USED TO ENRICH OUR UNDERSTANDING OF THE RELATIONSHIP OF YOGA PRACTICE AND SMOKING ABSTINENCE. CONCLUSIONS: THIS STUDY WILL PROVIDE A STRINGENT TEST OF THE RELATIVE EFFICACY OF YOGA COMPARED TO A CONDITION THAT CONTROLS FOR CONTACT TIME AND ATTENTION. THE USE OF MIXED METHODOLOGY ALSO PROVIDES THE OPPORTUNITY TO VALIDATE EXISTING KNOWLEDGE ABOUT YOGA AND HELPS TO EXPLORE NEW THEMES FOR FUTURE MINDFULNESS AND YOGA RESEARCH. 2014 9 491 21 CO-DESIGNING A NEW YOGA-BASED MINDFULNESS INTERVENTION FOR SURVIVORS OF STROKE: A FORMATIVE EVALUATION. MOVEMENT-BASED MINDFULNESS INTERVENTIONS (MBI) ARE COMPLEX, MULTI-COMPONENT INTERVENTIONS FOR WHICH THE DESIGN PROCESS IS RARELY REPORTED. FOR PEOPLE WITH STROKE, EMERGING EVIDENCE SUGGESTS BENEFITS, BUT MAINSTREAM PROGRAMS ARE GENERALLY UNSUITABLE. WE AIMED TO DESCRIBE THE PROCESSES INVOLVED AND TO CONDUCT A FORMATIVE EVALUATION OF THE DEVELOPMENT OF A NOVEL YOGA-BASED MBI DESIGNED FOR SURVIVORS OF STROKE. WE USED THE MEDICAL RESEARCH COUNCIL COMPLEX INTERVENTIONS FRAMEWORK AND PRINCIPLES OF CO-DESIGN. WE PURPOSEFULLY APPROACHED HEALTH PROFESSIONALS AND CONSUMERS TO ESTABLISH AN ADVISORY COMMITTEE FOR DEVELOPING THE INTERVENTION. MEMBERS COLLABORATED AND ITERATIVELY REVIEWED THE DESIGN AND CONTENT OF THE PROGRAM, FORMATTED INTO A TRAINING MANUAL. FOUR EXTERNAL YOGA TEACHERS INDEPENDENTLY REVIEWED THE PROGRAM. FORMATIVE EVALUATION INCLUDED REVIEW OF MULTIPLE DATA SOURCES AND DOCUMENTATION (E.G., FORMAL MEETING MINUTES, FOCUS GROUP DISCUSSIONS, RESEARCHER OBSERVATIONS). THE DATA WERE SYNTHESIZED USING INDUCTIVE THEMATIC ANALYSIS. THREE BROAD THEMES EMERGED: (A) MBI CONTENT AND TERMINOLOGY; (B) MANUAL DESIGN AND READABILITY; AND (C) BARRIERS AND ENABLERS TO DELIVER THE INTERVENTION. VARIOUS PERSPECTIVES AND FEEDBACK ON ESSENTIAL COMPONENTS GUIDED FINALIZING THE PROGRAM. THE DESIGN PHASE OF A NOVEL YOGA-BASED MBI WAS STRENGTHENED BY INTERDISCIPLINARY, CONSUMER CONTRIBUTIONS AND PEER REVIEW. THE 12-WEEK INTERVENTION IS READY FOR TESTING AMONG SURVIVORS OF STROKE. 2021 10 347 31 ASSESSING FIDELITY OF IMPLEMENTATION (FOI) FOR SCHOOL-BASED MINDFULNESS AND YOGA INTERVENTIONS: A SYSTEMATIC REVIEW. AS SCHOOL-BASED MINDFULNESS AND YOGA PROGRAMS GAIN POPULARITY, THE SYSTEMATIC STUDY OF FIDELITY OF PROGRAM IMPLEMENTATION (FOI) IS CRITICAL TO PROVIDE A MORE ROBUST UNDERSTANDING OF THE CORE COMPONENTS OF MINDFULNESS AND YOGA INTERVENTIONS, THEIR POTENTIAL TO IMPROVE SPECIFIED TEACHER AND STUDENT OUTCOMES, AND OUR ABILITY TO IMPLEMENT THESE PROGRAMS CONSISTENTLY AND EFFECTIVELY. THIS PAPER REVIEWS THE CURRENT STATE OF THE SCIENCE WITH RESPECT TO INCLUSION AND REPORTING OF FOI IN PEER-REVIEWED STUDIES EXAMINING THE EFFECTS OF SCHOOL-BASED MINDFULNESS AND/OR YOGA PROGRAMS TARGETING STUDENTS AND/OR TEACHERS IMPLEMENTED IN GRADES KINDERGARTEN THROUGH TWELVE (K-12) IN NORTH AMERICA. ELECTRONIC SEARCHES IN PSYCHINFO AND WEB OF SCIENCE FROM THEIR INCEPTION THROUGH MAY 2014, IN ADDITION TO HAND SEARCHES OF RELEVANT REVIEW ARTICLES, IDENTIFIED 312 PUBLICATIONS, 48 OF WHICH MET INCLUSION CRITERIA. FINDINGS INDICATED A RELATIVE PAUCITY OF RIGOROUS FOI. FEWER THAN 10% OF STUDIES OUTLINED POTENTIAL CORE PROGRAM COMPONENTS OR REFERENCED A FORMAL THEORY OF ACTION, AND FEWER THAN 20% ASSESSED ANY ASPECT OF FOI BEYOND PARTICIPANT DOSAGE. THE EMERGING NATURE OF THE EVIDENCE BASE PROVIDES A CRITICAL WINDOW OF OPPORTUNITY TO GRAPPLE WITH KEY ISSUES RELEVANT TO FOI OF MINDFULNESS-BASED AND YOGA PROGRAMS, INCLUDING IDENTIFYING ESSENTIAL ELEMENTS OF THESE PROGRAMS THAT SHOULD BE FAITHFULLY IMPLEMENTED AND HOW WE MIGHT DEVELOP RIGOROUS MEASURES TO ACCURATELY CAPTURE THEM. CONSIDERATION OF THESE QUESTIONS AND SUGGESTED NEXT STEPS ARE INTENDED TO HELP ADVANCE THE EMERGING FIELD OF SCHOOL-BASED MINDFULNESS AND YOGA INTERVENTIONS. 2016 11 1294 19 GUIDELINES FOR DEVELOPING YOGA INTERVENTIONS FOR RANDOMIZED TRIALS. LITTLE GUIDANCE IS AVAILABLE TO ASSIST RESEARCHERS IN DEVELOPING TREATMENT PROTOCOLS FOR RESEARCH ON YOGA FOR HEALTH CONCERNS. BECAUSE YOGA IS A COMPLEX MULTIFACTORIAL MIND-BODY DISCIPLINE HISTORICALLY DEVELOPED FOR NONMEDICAL PURPOSES, NUMEROUS DECISIONS MUST BE MADE IN ORDER TO THOUGHTFULLY DEVELOP SUCH PROTOCOLS. IN THIS PAPER, A SYSTEMATIC APPROACH IS PROPOSED TO ASSIST RESEARCHERS IN SELECTING AN INTERVENTION THAT IS APPROPRIATE FOR THE CONDITION UNDER CONSIDERATION AND EXPLICITLY DEVELOPED. RESEARCHERS NEED TO CONSIDER THE TYPE OR "STYLE" OF YOGA, THE COMPONENTS TO INCLUDE (E.G., BREATHING EXERCISES, POSTURES) AS WELL AS THE SPECIFIC PROTOCOL FOR EACH COMPONENT, THE DOSE TO BE DELIVERED (FREQUENCY, DURATION OF PRACTICE, AND THE TOTAL DURATION OF PRACTICE), AND ISSUES RELATED TO SELECTION OF INSTRUCTORS AND MONITORING THE FIDELITY TO THE INTERVENTION. EACH OF THESE DOMAINS AND THE KEY ISSUES FOR THE DEVELOPMENT OF PROTOCOLS IS DISCUSSED. FINALLY, SOME AREAS FOR FURTHER RESEARCH RELATED TO PROTOCOL DEVELOPMENT ARE RECOMMENDED. 2012 12 2032 20 TAILORING TRAUMA-SENSITIVE YOGA FOR HIGH-RISK POPULATIONS IN PUBLIC-SECTOR SETTINGS. LOW-INCOME, RACIAL-MINORITY, HIGH-RISK POPULATIONS HAVE LIMITED ACCESS TO EVIDENCE-BASED TREATMENTS FOR POSTTRAUMATIC STRESS DISORDER (PTSD), AND THEIR ACCEPTANCE OF COMPLEMENTARY INTERVENTIONS IS UNKNOWN. TRAUMA CENTER TRAUMA-SENSITIVE YOGA (TC-TSY), WHICH HAS DEMONSTRATED EFFICACY IN COMMUNITY SAMPLES, HAS NOT YET BEEN WIDELY USED WITH ETHNIC MINORITY LOW-INCOME INDIVIDUALS. THIS ARTICLE PRESENTS A CULTURALLY TAILORED VERSION OF A TC-TSY INTERVENTION DELIVERED AS A DROP-IN SERVICE IN A PUBLIC HOSPITAL-BASED CLINIC TO PATIENTS WITH HISTORIES OF INTERPERSONAL VIOLENCE AND SUICIDE ATTEMPTS. TC-TSY WAS ITERATIVELY TAILORED TO MEET THE UNIQUE CLINICAL NEEDS OF INDIVIDUALS WITHIN THIS SETTING. GROUP FACILITATOR OBSERVATIONS ARE SUMMARIZED; THEY DESCRIBE A SUCCESSFUL INITIAL IMPLEMENTATION AND CULTURALLY INFORMED ADAPTATION OF THE GROUP INTERVENTION. THE FACILITATORS' OBSERVATIONS ILLUSTRATED THAT GROUP MEMBERS ACCEPTED THE INTEGRATION OF THIS STRUCTURED, GENTLE YOGA PRACTICE INTO OUTPATIENT BEHAVIORAL HEALTH PROGRAMMING AND IDENTIFIED SITE-SPECIFIC MODIFICATIONS TO INFORM FORMAL STUDY. THE PROCESS BY WHICH TC-TSY WAS ADAPTED AND IMPLEMENTED FOR BLACK INDIVIDUALS WITH A HISTORY OF INTERPERSONAL TRAUMA AT RISK FOR SUICIDAL BEHAVIOR CAN SERVE AS A GUIDE FOR TAILORING OTHER COMPLEMENTARY, INTEGRATIVE INTERVENTIONS TO MEET THE NEEDS OF UNIQUE CLINICAL SETTINGS. THIS PROCESS IS OFFERED AS A FOUNDATION FOR FUTURE SYSTEMATIC TESTING OF THIS COMPLEMENTARY, INTEGRATED, CULTURALLY ADAPTED TRAUMA THERAPY IN HIGH-RISK CLINICAL POPULATIONS. 2021 13 1908 30 REVIEW: YOGA AND MINDFULNESS FOR YOUTH WITH AUTISM SPECTRUM DISORDER: REVIEW OF THE CURRENT EVIDENCE. BACKGROUND: YOGA AND MINDFULNESS-BASED PROGRAMS ARE BECOMING INCREASINGLY POPULAR AS A SUPPLEMENTAL INTERVENTION FOR CHILDREN AND ADOLESCENTS WITH AUTISM SPECTRUM DISORDERS (ASD). INCREASING NUMBERS OF CHILDREN, PARENTS, AND SCHOOLS ARE PARTICIPATING IN PROGRAMS AROUND THE COUNTRY WITH AN ENTHUSIASM THAT FAR EXCEEDS THE RESEARCH SUPPORT FOR THEIR EFFICACY. THERAPIES THAT ARE SAFE BUT NOT EFFECTIVE MAY NOT CAUSE IMMEDIATE HARM. NEVERTHELESS, THE MISAPPROPRIATION OF LIMITED TIME AND FINANCIAL RESOURCES MAY RESULT IN MISSED OPPORTUNITIES. THE NEED FOR CLEARLY DEFINED, EVIDENCE-BASED THERAPIES FOR YOUTH WITH ASD IS ESSENTIAL. METHOD: ELECTRONIC DATABASES WERE SEARCHED FOR PEER-REVIEWED INTERVENTION RESEARCH STUDIES USING THE KEY WORDS AUTISTIC OR AUTISM IN COMBINATION WITH YOGA, MINDFULNESS, OR MEDITATION. EIGHT STUDIES MET INCLUSION CRITERIA. RESULTS: THE FINDINGS ARE DESCRIBED IN THIS CRITICAL REVIEW OF EIGHT EMPIRICAL RESEARCH STUDIES THAT IMPLEMENTED YOGA AND MINDFULNESS-BASED INTERVENTIONS FOR CHILDREN WITH ASD. ALTHOUGH FEW STUDIES REPORTED IMPROVEMENTS IN CORE SYMPTOMS OF ASD, PRELIMINARY FINDINGS SUGGEST THAT YOGA AND MINDFULNESS-BASED INTERVENTIONS ARE FEASIBLE AND MAY IMPROVE A VARIETY OF PROSOCIAL BEHAVIORS, INCLUDING COMMUNICATION AND IMITATIVE BEHAVIORS; INCREASED TOLERANCE OF SITTING AND OF ADULT PROXIMITY; SELF-CONTROL; QUALITY OF LIFE; AND SOCIAL RESPONSIVENESS, SOCIAL COMMUNICATION, SOCIAL COGNITION, PREOCCUPATIONS, AND SOCIAL MOTIVATION. REDUCTIONS IN AGGRESSIVE BEHAVIORS, IRRITABILITY, LETHARGY, SOCIAL WITHDRAWAL, AND NONCOMPLIANCE WERE ALSO REPORTED. CONCLUSIONS: BASED ON THE AVAILABLE LITERATURE, THE EMPIRICAL EVIDENCE TO SUPPORT THE EFFICACY OF YOGA AND MINDFULNESS-BASED INTERVENTIONS FOR CHILDREN AND ADOLESCENTS WITH ASD IS INCONCLUSIVE. THE CURRENT BODY OF RESEARCH HAS SIGNIFICANT LIMITATIONS, INCLUDING SMALL SAMPLE SIZES, NO FIDELITY MEASURES, AND NO CONTROL GROUPS. EACH OF THE EIGHT STUDIES, HOWEVER, REPORTED SOME POSITIVE EFFECTS ON SOCIAL, EMOTIONAL, OR BEHAVIORAL METRICS. THESE EARLY RESULTS ARE PROMISING AND SUFFICIENT TO WARRANT SUPPORT FOR FURTHER RESEARCH. 2019 14 2035 15 TELE-YOGA FOR CHRONIC PAIN: CURRENT STATUS AND FUTURE DIRECTIONS. PAIN IS A PERVASIVE, DEBILITATING DISORDER THAT IS RESISTANT TO LONG-TERM PHARMACOLOGICAL INTERVENTIONS. ALTHOUGH PSYCHOLOGICAL THERAPIES SUCH AS COGNITIVE BEHAVIOR THERAPY DEMONSTRATE MODERATE EFFICACY, MANY INDIVIDUALS CONTINUE TO HAVE ONGOING DIFFICULTIES FOLLOWING TREATMENT. THERE IS A CURRENT TREND TO ESTABLISH COMPLEMENTARY AND INTEGRATIVE HEALTH INTERVENTIONS FOR CHRONIC PAIN, FOR WHICH YOGA HAS BEEN FOUND TO HAVE EXCITING POTENTIAL. NEVERTHELESS, AN IMPORTANT CONSIDERATION WITHIN THE FIELD IS ACCESSIBILITY TO ADEQUATE CARE. TELEHEALTH CAN BE USED TO PROVIDE REAL-TIME INTERACTIVE VIDEO CONFERENCING LEADING TO INCREASED ACCESS TO HEALTH CARE FOR INDIVIDUALS LOCATED REMOTELY OR WHO OTHERWISE HAVE DIFFICULTY ACCESSING SERVICES, PERHAPS THROUGH ISSUES OF MOBILITY OR PROXIMITY OF ADEQUATE SERVICES. THIS ARTICLE ASSESSES THE CURRENT STATUS AND FEASIBILITY OF IMPLEMENTING TELE-YOGA FOR CHRONIC PAIN. METHODOLOGICAL LIMITATIONS AND RECOMMENDATIONS FOR FUTURE RESEARCH ARE DISCUSSED. 2018 15 249 17 A YOGA INTERVENTION FOR YOUNG CHILDREN: SELF-REGULATION AND EMOTION REGULATION. YOGA-BASED INTERVENTIONS HAVE BEEN IMPLEMENTED IN SCHOOLS AND DEMONSTRATED PROMISING RESULTS ON STUDENTS' SELF-REGULATION OUTCOMES. NEVERTHELESS, THERE IS LIMITED LITERATURE ON THE EFFECTS THAT YOGA MAY HAVE FOR CHILDREN IN THE EARLY PRIMARY GRADES, DESPITE THE EVIDENCE DEMONSTRATING THAT THIS IS AN OPPORTUNE PERIOD IN DEVELOPMENT FOR EARLY SELF-REGULATION. FEW STUDIES HAVE FOCUSED ON YOUNG CHILDREN LIVING IN THE CONTEXT OF ECONOMIC DIFFICULTY, WHICH CAN HINDER CHILDREN'S DEVELOPMENT OF SELF-REGULATORY SKILLS AND EDUCATIONAL TRAJECTORIES. THE EFFECTS OF AN EIGHT-WEEK YOGA INTERVENTION ON ECONOMICALLY DISADVANTAGED PRE-KINDERGARTEN AND KINDERGARTEN CHILDREN'S SELF-REGULATION AND EMOTION REGULATION WERE EXAMINED VIA A PAIRED WITHIN-SUBJECTS COMPARISON STUDY. NINE CLASSROOMS WERE ASSIGNED TO THE YOGA INTERVENTION (TREATMENT FIRST, TXFIRST; N = 90) OR A WAIT-LIST CONTROL GROUP (TREATMENT SECOND, TXSECOND; N = 64). ALL CHILDREN WERE ASSESSED AT PRE-INTERVENTION (TIME 1), POST-INTERVENTION ASSESSMENT FOR TXFIRST (TIME 2), AND POST-INTERVENTION ASSESSMENT FOR TXSECOND (TIME 3). CHILDREN DEMONSTRATED SIGNIFICANT PREDICTED GAINS ON A BEHAVIORAL TASK OF SELF-REGULATION AND DECLINES IN TEACHER-RATED SUBMISSIVE VENTING AND TOTAL BEHAVIOR PROBLEMS. IMPLICATIONS FOR FUTURE RESEARCH ARE DISCUSSED, WITH A FOCUS ON INCLUDING FOLLOW-UP ASSESSMENTS AND MULTIPLE DIMENSIONS OF FIDELITY OF IMPLEMENTATION. 2021 16 551 18 CONVENIENT AND LIVE MOVEMENT (CALM) FOR WOMEN UNDERGOING BREAST CANCER TREATMENT: CHALLENGES AND RECOMMENDATIONS FOR INTERNET-BASED YOGA RESEARCH. OBJECTIVE: TO CONDUCT A PILOT TRIAL OF INTERNET-BASED, CANCER-ADAPTED YOGA FOR WOMEN RECEIVING BREAST CANCER TREATMENT. DESIGN: WOMEN UNDERGOING RADIATION OR CHEMOTHERAPY FOR BREAST CANCER WERE RECRUITED FOR 12, 75-MIN, BIWEEKLY, CANCER-ADAPTED YOGA CLASSES DELIVERED VIA INTERNET-BASED, MULTIPOINT VIDEOCONFERENCING. DATA WERE COLLECTED ON FEASIBILITY AND ACCEPTABILITY, INCLUDING QUALITATIVE FEEDBACK FROM PARTICIPANTS AND THE YOGA INSTRUCTOR. RESULTS: AMONG 42 WOMEN APPROACHED, 13 DECLINED ELIGIBILITY SCREENING, AND 23 WERE INELIGIBLE. ALL 6 WOMEN WHO WERE ELIGIBLE PROVIDED CONSENT, BUT 2 WITHDREW PRIOR TO BEGINNING YOGA CLASSES. THE REMAINING 4 PARTICIPANTS ATTENDED 1-11 OF 12 ONLINE YOGA CLASSES. IN POST-INTERVENTION INTERVIEWS, PARTICIPANTS AND THE INSTRUCTOR AGREED THAT INTERNET-BASED YOGA CLASSES HOLD GREAT POTENTIAL FOR INCREASING ACCESS AND IMPROVING PSYCHOLOGICAL OUTCOMES IN ADULTS WITH CANCER. QUALITATIVE FEEDBACK FROM PARTICIPANTS REVEALED SUGGESTIONS FOR FUTURE TRIALS OF INTERNET-BASED, CANCER-ADAPTED YOGA CLASSES, INCLUDING: CONTINUED USE OF GROUP FORMAT; OFFERING MORE VARIED CLASS TIMES TO ACCOMMODATE PATIENTS' DEMANDING SCHEDULES AND FLUCTUATING SYMPTOMS; ENROLLING PATIENTS AFTER THEY HAVE ACCLIMATED TO OR COMPLETED CANCER TREATMENT; STREAMLINING THE TECHNOLOGY INTERFACE; AND CAREFUL ATTENTION TO PARTICIPANT BURDEN WHEN DESIGNING SURVEYS/FORMS. THE INSTRUCTOR RECOMMENDED CLOSED SESSION COURSES, AS OPPOSED TO ROLLING ENROLLMENT; TEACHING THE SAME MODIFIED POSES FOR ALL PARTICIPANTS, RATHER THAN INDIVIDUAL TAILORING; AND USING A LARGE SCREEN TO ALLOW CLOSER MONITORING OF STUDENTS' CLASS EXPERIENCE. CONCLUSIONS: INTERNET DELIVERY MAY INCREASE PATIENTS' ACCESS TO CANCER-ADAPTED YOGA CLASSES, BUT CANCER-RELATED AND TECHNOLOGICAL BARRIERS REMAIN. THIS STUDY INFORMS HOW TO OPTIMALLY DESIGN YOGA CLASSES, TECHNOLOGY, AND RESEARCH PROCEDURES TO MAXIMIZE FEASIBILITY AND ACCEPTABILITY IN FUTURE TRIALS. 2018 17 1872 14 RAPID CONVERSION OF A GROUP-BASED YOGA TRIAL FOR DIVERSE OLDER WOMEN TO HOME-BASED TELEHEALTH: LESSONS LEARNED USING ZOOM TO DELIVER MOVEMENT-BASED INTERVENTIONS. THIS BRIEF REPORT DESCRIBES THE RAPID CONVERSION OF A RANDOMIZED TRIAL OF A HATHA-BASED YOGA PROGRAM FOR OLDER WOMEN WITH URINARY INCONTINENCE TO A TELEHEALTH VIDEOCONFERENCE PLATFORM DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PANDEMIC. INTERIM RESULTS DEMONSTRATE THE FEASIBILITY OF RECRUITING AND RETAINING PARTICIPANTS ACROSS A WIDE RANGE OF AGES AND ETHNIC BACKGROUNDS, BUT ALSO POINT TO POTENTIAL OBSTACLES AND SAFETY CONCERNS ARISING FROM TELEHEALTH-BASED INSTRUCTION. THE INVESTIGATORS PRESENT LESSONS LEARNED ABOUT THE BENEFITS AND CHALLENGES OF USING TELEHEALTH PLATFORMS TO DELIVER MOVEMENT-BASED INTERVENTIONS AND CONSIDER STRATEGIES TO PROMOTE ACCESSIBLE AND WELL-TOLERATED TELEHEALTH-BASED YOGA PROGRAMS FOR OLDER AND DIVERSE POPULATIONS. CLINICAL TRIAL REGISTRATION NUMBER: NCT03672461. 2022 18 2036 20 TELE-YOGA IN LONG TERM ILLNESS-PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL INCLUDING A PROCESS EVALUATION AND RESULTS FROM A PILOT STUDY. BACKGROUND: FOR PEOPLE WITH LONG-TERM ILLNESS, DEBILITATED BY SEVERE SYMPTOMS, IT CAN BE DIFFICULT TO ATTEND REGULAR YOGA CLASSES. WE HAVE THEREFORE DEVELOPED A TELE-HEALTH FORMAT OF YOGA THAT CAN BE DELIVERED IN THE HOME. THE TELE-YOGA WAS CO-DESIGNED WITH MEMBERS OF A PATIENT-ORGANISATION, YOGA-INSTRUCTOR, AND IT-TECHNICIAN. IT INCLUDES LIVE-STREAMED GROUP-YOGA SESSIONS TWICE A WEEK AND AN APP WITH INSTRUCTIONS ON HOW TO SELF-PERFORM YOGA. AIM: TO DESCRIBE A STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL (RCT) INCLUDING A PROCESS EVALUATION AND REPORT ON A PILOT STUDY EVALUATING METHOD- AND INTERVENTION-RELATED COMPONENTS INCLUDING FEASIBILITY, SAFETY, AND EFFICACY. METHODS: TEN PARTICIPANTS WITH HEART FAILURE AGED BETWEEN 41-76 YEARS WERE RANDOMISED TO TELE-YOGA (N = 5) OR TO THE CONTROL GROUP (N = 5). IN THE PILOT STUDY RECRUITMENT, ENROLMENT, RANDOMISATION, AND DATA COLLECTION OF ALL OUTCOMES INCLUDING PRIMARY, SECONDARY AND PROCESS EVALUATION MEASURES WERE TESTED ACCORDING TO THE STUDY PROTOCOL. FIDELITY, ADHERENCE AND ACCEPTABILITY TO THE TELE-YOGA GROUP TRAINING AND APP USE WAS DETERMINED. SAFETY WAS ASSESSED BY ADVERSE EVENTS. RESULTS: THE PILOT REVEALED THAT THE METHODOLOGICAL ASPECT OF THE PROTOCOL WORKED SUFFICIENTLY IN ALL ASPECTS EXCEPT FOR MISSING DATA IN THE PHYSICAL TEST OF TWO PARTICIPANTS AND ONE PARTICIPANT IN THE CONTROL-GROUP THAT DROPPED OUT OF THE STUDY AT THREE MONTHS FOLLOW-UP. THE TELE-YOGA TRAINING DID NOT LEAD TO ANY ADVERSE EVENTS OR INJURIES, ADHERENCE OF TELE-YOGA WAS SUFFICIENT ACCORDING TO PRESET LIMITS. THE TELE-YOGA INTERVENTION ALSO SHOWED SOME FAVOURABLE TRENDS OF IMPROVEMENTS IN THE COMPOSITE-END POINT COMPARED TO THE ACTIVE CONTROL GROUP. HOWEVER, SINCE DATA ONLY WAS PRESENTED DESCRIPTIVELY DUE TO THE SMALL SAMPLE SIZE, THE IMPACT OF THESE TRENDS SHOULD BE INTERPRETED CAREFULLY. CONCLUSION: OUR PILOT STUDY SHOWED PROMISING RESULTS IN FEASIBILITY, SAFETY, AND ACCEPTABILITY OF THE TELE-YOGA INTERVENTION. SOME CHANGES IN THE PROTOCOL HAVE BEEN MADE TO DECREASE THE RISK OF MISSING DATA IN THE MEASURES OF PHYSICAL FUNCTION AND IN THE FULL-SCALE RCT NOW ONGOING THE RESULTS OF THE SAMPLE SIZE CALCULATION FOR 300 PARTICIPANTS HAVE INCLUDED THE ESTIMATED LEVEL OF DROP OUTS AND MISSING DATA. 2021 19 124 18 A PILOT STUDY OF YOGA FOR CHRONIC HEADACHES IN YOUTH: PROMISE AMIDST CHALLENGES. THE PRIMARY AIM OF THE CURRENT STUDY WAS TO PROVIDE PRELIMINARY DATA ON THE FEASIBILITY, ACCEPTABILITY, AND SAFETY OF ALIGNMENT-BASED YOGA FOR YOUTHS WITH CHRONIC HEADACHES. A SECONDARY AIM WAS TO PROVIDE PRELIMINARY ESTIMATES OF YOGA'S ABILITY TO IMPROVE HEADACHE PAIN, DAILY FUNCTIONING, QUALITY OF LIFE, AND ANXIETY LEVEL IN THIS POPULATION. THE YOGA INTERVENTION CONSISTED OF 8 WEEKLY, 75-MINUTE CLASSES. PARTICIPANT FLOW DATA REVEALED CHALLENGES TO FEASIBILITY PRIMARILY DUE TO RECRUITMENT AND RETENTION. SCORES ON MOST OUTCOME MEASURES CHANGED IN THE PREDICTED DIRECTION WITH MEDIUM EFFECT SIZES FOUND FOR THE FUNCTIONAL OUTCOMES. PAIN MEASURES DID NOT CHANGE SIGNIFICANTLY. THIS PILOT SUGGESTS THAT YOGA FOR PEDIATRIC HEADACHES MAY BE ACCEPTABLE, AS INDICATED BY POSITIVE PARENT AND PARTICIPANT RATINGS OF THE YOGA EXPERIENCE. THESE PRELIMINARY FINDINGS SUGGEST THAT YOGA TRIALS FOR PEDIATRIC HEADACHES INCLUDE BOTH CHALLENGES AND PROMISE. RECOMMENDATIONS FOR OVERCOMING CHALLENGES INCLUDE DESIGNS THAT OPTIMIZE FAMILY CONVENIENCE. 2014 20 1233 19 FEASIBILITY AND PRELIMINARY EFFICACY OF TAILORED YOGA IN SURVIVORS OF HEAD AND NECK CANCER: A PILOT STUDY. PURPOSE: TREATMENT FOR HEAD AND NECK CANCER (HNC) RESULTS IN LONG-TERM TOXICITIES AND INCREASED PHYSICAL AND PSYCHOSOCIAL SURVIVOR BURDEN. THERE ARE A LIMITED NUMBER OF TREATMENTS FOR THESE LATE EFFECTS. YOGA POSTURES, BREATH WORK, RELAXATION, AND MEDITATION, MAY IMPROVE THESE LATE EFFECTS. THE PURPOSE OF THIS STUDY WAS TO EXAMINE THE FEASIBILITY OF A TAILORED YOGA PROGRAM IN HNC SURVIVORS AND OBTAIN PRELIMINARY EFFICACY DATA. METHODS: THIS WAS A RANDOMIZED WAIT-LIST CONTROL STUDY OF YOGA-NAIVE HNC SURVIVORS WHO WERE >3 MONTHS POST-CANCER TREATMENT. BASELINE DATA WERE COLLECTED. PARTICIPANTS WERE RANDOMIZED TO EITHER AN 8-WEEK HATHA YOGA INTERVENTION GROUP OR A WAIT-LIST GROUP. FEASIBILITY AND EFFICACY DATA WERE COLLECTED. AT 4 AND 8 WEEKS, PATIENTS UNDERWENT A REPEAT ASSESSMENT OF HEALTH. WAIT-LIST CONTROL GROUP PARTICIPANTS WERE OFFERED THE YOGA PROGRAM AFTER DATA COLLECTION. DESCRIPTIVE STATISTICS EVALUATED FEASIBILITY. MIXED EFFECTS GENERAL LINEAR MODELS WERE USED TO GENERATE ESTIMATES OF THE EFFICACY OUTCOMES. RESULTS: SEVENTY-THREE INDIVIDUALS WERE SCREENED AND 40 WERE ELIGIBLE. ALL ELIGIBLE INDIVIDUALS CONSENTED AND ENROLLED. FIVE OF THE INTERVENTION GROUP DISCONTINUED EARLY AND NONE IN THE WAIT-LIST CONTROL GROUP. FEASIBILITY WAS AFFIRMED AS PARTICIPANTS WERE RECRUITED AND RETAINED IN THE STUDY, THERE WERE NO ADVERSE EVENTS, FIDELITY TO PROTOCOL WAS DEMONSTRATED, AND SATISFACTION RATES WERE HIGH. EFFICACY MEASURES INDICATED POTENTIAL BENEFIT FOR SHOULDER RANGE OF MOTION ( D = 0.57-0.86, P < .05), PAIN ( D = 0.67-0.90, P