1 168 133 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 2 1729 36 PERSONALISED YOGA FOR BURNOUT AND TRAUMATIC STRESS IN JUNIOR DOCTORS. OBJECTIVES: JUNIOR DOCTORS ARE FREQUENTLY EXPOSED TO OCCUPATIONAL AND TRAUMATIC STRESS, SOMETIMES WITH TRAGIC CONSEQUENCES. MINDFULNESS-BASED AND FITNESS INTERVENTIONS ARE INCREASINGLY USED TO MITIGATE THIS, BUT HAVE NOT BEEN COMPARED.WE CONDUCTED A RANDOMISED, CONTROLLED PILOT TRIAL TO ASSESS THE FEASIBILITY, ACCEPTABILITY AND EFFECTIVENESS OF THESE INTERVENTIONS IN JUNIOR DOCTORS. METHODS: WE RANDOMISED PARTICIPANTS (N=21) TO WEEKLY 1-HOUR SESSIONS OF PERSONALISED, TRAUMA-INFORMED YOGA (N=10), WITH A 4-HOUR WORKSHOP, AND EHEALTH HOMEWORK; OR GROUP-FORMAT FITNESS (N=8) IN AN EXISTING WELLNESS PROGRAMME, MDOK. BURNOUT, TRAUMATIC STRESS AND SUICIDALITY WERE MEASURED AT BASELINE AND 8 WEEKS. RESULTS: BOTH INTERVENTIONS REDUCED BURNOUT, AND YOGA INCREASED COMPASSION SATISFACTION WITHIN GROUP ON THE PROFESSIONAL QUALITY OF LIFE SCALE, WITHOUT DIFFERENCE BETWEEN GROUPS ON THIS MEASURE.PERSONALISED YOGA SIGNIFICANTLY REDUCED DEPERSONALISATION (Z=-1.99, P=0.05) COMPARED WITH GROUP FITNESS ON THE MASLACH BURNOUT INVENTORY (MBI-HSS (MP)) AND SHOWED GREATER FLEXIBILITY CHANGES. BOTH INTERVENTIONS INCREASED MBI PERSONAL ACCOMPLISHMENT, WITH NO CHANGES IN OTHER SELF-REPORT PSYCHOLOGICAL OR PHYSIOLOGICAL METRICS, INCLUDING BREATH-COUNTING.PARTICIPANTS DOING ONE-TO-ONE YOGA RATED IT MORE HIGHLY OVERALL (P=0.02) THAN GROUP FITNESS, AND REPORTED IT COMPARATIVELY MORE BENEFICIAL FOR MENTAL (P=0.01) AND PHYSICAL HEALTH (P=0.05). FACE-TO-FACE WEEKLY SESSIONS WERE 100% ATTENDED IN YOGA, BUT ONLY 45% IN FITNESS. CONCLUSION: IN THIS PILOT TRIAL, BOTH YOGA AND FITNESS IMPROVED BURNOUT, BUT TRAUMA-INFORMED YOGA REDUCED DEPERSONALISATION IN JUNIOR DOCTORS MORE THAN GROUP-FORMAT FITNESS. ONE-TO-ONE YOGA WAS BETTER ADHERED THAN FITNESS, BUT WAS MORE RESOURCE INTENSIVE. JUNIOR DOCTORS NEED LARGER-SCALE COMPARATIVE RESEARCH OF THE EFFECTIVENESS AND IMPLEMENTATION OF INDIVIDUAL, ORGANISATIONAL AND SYSTEMIC MENTAL HEALTH INTERVENTIONS. TRIAL REGISTRATION NUMBER: ANZCTR 12618001467224. 2020 3 2032 30 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 4 555 38 CORTISOL AND ANTIDEPRESSANT EFFECTS OF YOGA. CONTEXT: HYPERCORTISOLEMIA IS WELL-KNOWN IN DEPRESSION AND YOGA HAS BEEN DEMONSTRATED EARLIER TO REDUCE THE PARAMETERS OF STRESS, INCLUDING CORTISOL LEVELS. AIM: WE AIMED TO FIND THE ROLE OF YOGA AS AN ANTIDEPRESSANT AS WELL AS ITS ACTION ON LOWERING THE SERUM CORTISOL LEVELS. SETTINGS AND DESIGN: AN OPEN-LABELED STUDY CONSISTING OF THREE GROUPS (YOGA ALONE, YOGA ALONG WITH ANTIDEPRESSANT MEDICATION AND ANTIDEPRESSANT MEDICATION ALONE) WAS CONDUCTED AT A TERTIARY CARE PSYCHIATRY HOSPITAL. METHODOLOGY: OUT-PATIENT DEPRESSIVES WHO WERE NOT SUICIDAL WERE OFFERED YOGA AS A POSSIBLE ANTIDEPRESSANT THERAPY. A VALIDATED YOGA MODULE WAS USED AS THERAPY TAUGHT OVER A MONTH AND TO BE PRACTICED AT HOME DAILY. PATIENTS WERE FREE TO CHOOSE THE DRUGS IF THEIR PSYCHIATRIST ADVISED. PATIENTS (N=54) WERE RATED ON HAMILTON DEPRESSION RATING SCALE (HDRS) WITH SERUM CORTISOL MEASUREMENTS AT BASELINE AND AFTER 3 MONTHS. IN 54 PATIENTS, ASSESSMENTS AND BLOOD TEST RESULTS WERE BOTH AVAILABLE. 19 EACH RECEIVED YOGA ALONE OR WITH DRUGS AND 16 RECEIVED DRUGS ONLY. HEALTHY COMPARISON SUBJECTS (N=18) TOO UNDERWENT MORNING CORTISOL MEASUREMENTS ONCE. RESULTS: SERUM CORTISOL WAS HIGHER IN DEPRESSIVES COMPARED WITH CONTROLS. IN THE TOTAL SAMPLE, THE CORTISOL LEVEL DROPPED SIGNIFICANTLY AT THE END OF TREATMENT. MORE PATIENTS IN THE YOGA GROUPS HAD A DROP IN CORTISOL LEVELS AS COMPARED TO DRUG-ONLY GROUP. IN THE YOGA-ONLY GROUP, THE CORTISOL DROP CORRELATED WITH THE DROP IN HDRS SCORE (ANTIDEPRESSANT EFFECT). CONCLUSION: THE FINDINGS SUPPORT THAT YOGA MAY ACT AT THE LEVEL OF THE HYPOTHALAMUS BY ITS 'ANTI-STRESS' EFFECTS (REDUCING THE CORTISOL), TO BRING ABOUT RELIEF IN DEPRESSION. 2013 5 2325 56 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 /= 4 SESSIONS. EIGHTY PERCENT OF PARTICIPANTS IN THE YOGA CONDITION AND 65% IN THE SUPPORT GROUP INDICATED THAT THEY WERE HIGHLY SATISFIED WITH THE INTERVENTION. FOLLOWING TREATMENT, WOMEN IN THE YOGA INTERVENTION HAD MODEST IMPROVEMENTS IN SOME OUTCOMES; HOWEVER, OVERALL SYMPTOM LEVELS WERE LOW FOR WOMEN IN BOTH CONDITIONS. CONCLUSIONS: FINDINGS SUGGEST THAT THE YOGA INTERVENTION CONTENT WAS HIGHLY ACCEPTABLE TO PATIENTS WITH MBC, BUT THAT THERE ARE CHALLENGES TO IMPLEMENTING AN INTERVENTION INVOLVING EIGHT GROUP-BASED IN-PERSON SESSIONS. ALTERNATIVE MODES OF DELIVERY MAY BE NECESSARY TO REACH PATIENTS MOST IN NEED OF INTERVENTION. 2019 17 1341 26 HOW JUNIOR DOCTORS PERCEIVE PERSONALISED YOGA AND GROUP EXERCISE IN THE MANAGEMENT OF OCCUPATIONAL AND TRAUMATIC STRESSORS. OBJECTIVES: JUNIOR DOCTORS ARE EXPOSED TO OCCUPATIONAL AND TRAUMATIC STRESSORS, SOME OF WHICH ARE INHERENT TO MEDICINE. THIS CAN RESULT IN BURNOUT, MENTAL ILL-HEALTH AND SUICIDE. WITHIN A CROSSOVER PILOT STUDY COMPARING PERSONALISED, TRAUMA-INFORMED YOGA TO GROUP-FORMAT EXERCISE, QUALITATIVE INTERVIEWS WERE CONDUCTED TO UNDERSTAND THE EXPERIENCE OF JUNIOR DOCTORS AND WHETHER SUCH INTERVENTIONS WERE PERCEIVED TO HELP MANAGE THESE STRESSORS. METHODS: TWENTY-ONE DOCTORS, 76% FEMALE, WERE ORDER-RANDOMISED TO CONSECUTIVE 8-WEEK YOGA AND EXERCISE PROGRAMMES. FIFTY-TWO INTERVIEWS WERE RECORDED BEFORE AND AFTER EACH PROGRAMME. RESULTS: MANY PARTICIPANTS REPORTED BEING TIME POOR, SLEEP-AFFECTED, FREQUENTLY STRESSED AND OCCASIONALLY IN PHYSICAL PAIN/DISTRESS. MAJOR STRESSOR THEMES WERE WORKPLACE INCIVILITY, DEATH/HUMAN SUFFERING AND SHIFT WORK WITH MINIMAL SUPPORT. BOTH INTERVENTIONS WERE ACCEPTABLE FOR DIFFERENT REASONS. PERSONALISED YOGA OFFERED A THERAPEUTIC ALLIANCE, TIME TO CHECK-IN AND REDUCED ANXIETY/RUMINATION. GROUP EXERCISE PROVIDED ENERGY AND SOCIAL CONNECTION. ONE PARTICIPANT FOUND YOGA BENEFICIAL FOLLOWING AN ACUTE WORKPLACE TRAUMA: 'IT WAS REALLY EYE OPENING HOW MUCH I FELT MY BODY JUST NEEDED TO DETOX ... I WOULDN'T HAVE GONE TO A GROUP FITNESS THE NEXT DAY ... I JUST WANTED TO RELAX AND BREATHE ...WE STILL HAD A BIG DEBRIEF WHICH WAS GREAT ... (BUT) I ALMOST FELT LIKE ... I DEALT WITH IT PHYSICALLY AND EMOTIONALLY BEFORE GOING INTO IT (P20).' CONCLUSION: JUNIOR DOCTORS FOUND BOTH INTERVENTIONS USEFUL FOR STRESS MANAGEMENT ADJUNCTIVE TO OTHER ORGANISATIONAL PROGRAMMES THOUGH FOR DIFFERENT AND COMPLEMENTARY REASONS, POSSIBLY RELATED TO DELIVERY MODE. PERSONALISED, TRAUMA-INFORMED YOGA PROVIDED A CONFIDENTIAL THERAPEUTIC ALLIANCE WHEREAS GROUP EXERCISE OFFERED SOCIAL CONNECTION. 2021 18 199 33 A RESEARCH PROTOCOL FOR A PILOT, RANDOMIZED CONTROLLED TRIAL DESIGNED TO EXAMINE THE FEASIBILITY OF A DYADIC VERSUS INDIVIDUAL YOGA PROGRAM FOR FAMILY CAREGIVERS OF GLIOMA PATIENTS UNDERGOING RADIOTHERAPY. BACKGROUND: ALTHOUGH THE DIAGNOSIS AND TREATMENT OF A PRIMARY BRAIN TUMOR PRESENT UNIQUE CHALLENGES TO PATIENTS AND THEIR FAMILY CAREGIVERS, EVIDENCE-BASED SUPPORTIVE CARE INTERVENTIONS ARE GENERALLY LACKING. THE PRIMARY AIM OF THIS RESEARCH PROTOCOL IS TO DETERMINE THE FEASIBILITY OF IMPLEMENTING A DYADIC YOGA (DY) VERSUS A CAREGIVER YOGA (CY) INTERVENTION OR A WAIT-LIST CONTROL (WLC) GROUP USING A RANDOMIZED CONTROLLED TRIAL DESIGN. METHODS: SEVENTY-FIVE GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR FAMILY CAREGIVERS ARE RANDOMIZED TO THE DY, CY, OR A WLC GROUP. PATIENT-CAREGIVER DYADS IN THE DY GROUP AND CAREGIVERS IN THE CY GROUP RECEIVE 15 SESSIONS (45 MIN EACH) OVER THE COURSE OF PATIENTS' STANDARD RADIOTHERAPY (6 WEEKS). PATIENTS AND CAREGIVERS IN ALL GROUPS COMPLETE BASELINE ASSESSMENTS OF SYMPTOMS, QUALITY OF LIFE (QOL), AND HEALTH UTILIZATION OUTCOMES PRIOR TO RANDOMIZATION. FOLLOW-UP ASSESSMENTS ARE PERFORMED 6 WEEKS AND THEN AGAIN 3 MONTHS LATER. THE PRIMARY OUTCOME IS FEASIBILITY (I.E., >/= 50% OF ELIGIBLE DYADS CONSENT, >/= 70% OF ENROLLED DYADS COMPLETE ALL ASSESSMENTS, AND >/= 50% OF ALL PRACTICE SESSIONS ARE ATTENDED). WE WILL ALSO PERFORM PRIMARILY DESCRIPTIVE ANALYSES OF THE SELF-REPORTED OUTCOMES (E.G., FATIGUE, OVERALL QOL) AND EXPLORE POTENTIAL INTERVENTION MODERATORS (E.G., PERFORMANCE STATUS) TO INFORM A LARGER FUTURE TRIAL. CONCLUSION: THIS TRIAL WILL PROVIDE IMPORTANT INFORMATION REGARDING THE FEASIBILITY OF A DYADIC VERSUS A CAREGIVER YOGA INTERVENTION REGARDING SYMPTOM, QOL, AND HEALTH UTILIZATION OUTCOMES IN GLIOMA PATIENTS AND THEIR CAREGIVERS. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT02481349. 2019 19 2843 31 YOGA, COGNITIVE-BEHAVIOURAL THERAPY VERSUS EDUCATION TO IMPROVE QUALITY OF LIFE AND REDUCE HEALTHCARE COSTS IN PEOPLE WITH ENDOMETRIOSIS: A RANDOMISED CONTROLLED TRIAL. INTRODUCTION: ENDOMETRIOSIS IS A DEBILITATING CHRONIC INFLAMMATORY CONDITION HIGHLY BURDENSOME TO THE HEALTHCARE SYSTEM. THE PRESENT TRIAL WILL ESTABLISH THE EFFICACY OF (1) YOGA AND (2) COGNITIVE-BEHAVIOURAL THERAPY (CBT), ABOVE (3) EDUCATION, ON QUALITY OF LIFE, BIOPSYCHOSOCIAL OUTCOMES AND COST-EFFECTIVENESS. METHODS AND ANALYSIS: THIS STUDY IS A PARALLEL RANDOMISED CONTROLLED TRIAL. PARTICIPANTS WILL BE RANDOMLY ALLOCATED TO YOGA, CBT OR EDUCATION. PARTICIPANTS WILL BE ENGLISH-SPEAKING ADULTS, HAVE A DIAGNOSIS OF ENDOMETRIOSIS BY A QUALIFIED PHYSICIAN, WITH PAIN FOR AT LEAST 6 MONTHS, AND ACCESS TO INTERNET. PARTICIPANTS WILL ATTEND 8 WEEKLY GROUP CBT SESSIONS OF 120 MIN; OR 8 WEEKLY GROUP YOGA SESSIONS OF 60 MIN; OR RECEIVE WEEKLY EDUCATIONAL HANDOUTS ON ENDOMETRIOSIS. THE PRIMARY OUTCOME MEASURE IS QUALITY OF LIFE. THE ANALYSIS WILL INCLUDE MIXED-EFFECTS ANALYSIS OF VARIANCE AND LINEAR MODELS, COST-UTILITY ANALYSIS FROM A SOCIETAL AND HEALTH SYSTEM PERSPECTIVE AND QUALITATIVE THEMATIC ANALYSIS. ETHICS AND DISSEMINATION: ENROLMENT IN THE STUDY IS VOLUNTARY AND PARTICIPANTS CAN WITHDRAW AT ANY TIME. PARTICIPANTS WILL BE GIVEN THE OPTION TO DISCUSS THE STUDY WITH THEIR NEXT OF KIN/TREATING PHYSICIAN. FINDINGS WILL BE DISSEMINATED VIA PUBLICATIONS, CONFERENCES AND BRIEFS TO PROFESSIONAL ORGANISATIONS. THE UNIVERSITY'S MEDIA TEAM WILL ALSO BE USED TO FURTHER DISSEMINATE VIA LAY PERSON ARTICLES AND MEDIA RELEASES. TRIAL REGISTRATION NUMBER: ACTRN12620000756921P; PRE-RESULTS. 2021 20 116 34 A PILOT STUDY OF A YOGA MEDITATION PROTOCOL FOR PATIENTS WITH MEDICALLY REFRACTORY EPILEPSY. OBJECTIVE: THE OBJECTIVE WAS TO ASSESS THE EFFICACY OF A YOGA MEDITATION PROTOCOL (YMP) AS AN ADJUNCTIVE TREATMENT IN PATIENTS WITH DRUG-RESISTANT CHRONIC EPILEPSY. DESIGN: THE DESIGN WAS A PROSPECTIVE, NONRANDOMIZED, OPEN-LABEL, ADD-ON TRIAL WITH A 12-WEEK BASELINE PERIOD, FOLLOWED BY A 12-WEEK SUPERVISED YMP ADMINISTRATION PHASE. THE FREQUENCY OF COMPLEX PARTIAL SEIZURES (CPS) WAS ASSESSED AT 3, 6, AND 12 MONTHS OF THE TREATMENT PERIOD. SETTING: THE SETTING WAS A COMPREHENSIVE EPILEPSY CARE CENTER ATTACHED TO A TERTIARY REFERRAL MEDICAL INSTITUTION SITUATED ON THE SOUTHWEST COAST OF THE INDIAN PENINSULA. SUBJECTS: THE SUBJECTS WERE 20 PATIENTS (14 MALES AND 6 FEMALES, AGE RANGE 15 TO 47 YEARS, MEDIAN 27 YEARS) WITH UNEQUIVOCALLY ESTABLISHED DIAGNOSES OF EPILEPSY WITH AT LEAST 4 CPS (WITH OR WITHOUT SECONDARY GENERALIZATION) DURING THE PRECEDING 3 MONTHS. INTERVENTION: INTERVENTION CONSISTED OF A YMP 20 MINUTES TWICE DAILY (MORNINGS AND EVENINGS) AT HOME, AND SUPERVISED SESSIONS OF A YMP EVERY WEEK FOR 3 MONTHS. CONTINUATION OF THE YMP BEYOND 3 MONTHS WAS OPTIONAL. OUTCOME MEASURE: THE OUTCOME MEASURE WAS THE SEIZURE FREQUENCY AT 3, 6, AND 12 MONTHS OF THE TREATMENT PERIOD. THE SUBJECTS WITH > OR = 50% REDUCTION IN MONTHLY SEIZURE RATE FROM BASELINE WERE CLASSIFIED AS RESPONDERS, AND SUBJECTS WITH <50% SEIZURE REDUCTION AS NONRESPONDERS. RESULTS: AT 3 MONTHS, A REDUCTION IN SEIZURE FREQUENCY WAS NOTED IN ALL EXCEPT 1 PATIENT, SIX OF WHOM HAD > OR = 50% SEIZURE REDUCTION. OF 16 PATIENTS WHO CONTINUED THE YMP BEYOND 3 MONTHS, 14 PATIENTS RESPONDED AT 6 MONTHS; 6 OF THEM WERE SEIZURE-FREE FOR 3 MONTHS. ALL EIGHT PATIENTS WHO CONTINUED THE YMP BEYOND 6 MONTHS RESPONDED; THREE OF THEM WERE SEIZURE FREE FOR 6 MONTHS. CONCLUSIONS: IF CONFIRMED THROUGH RANDOMIZED TRIALS INVOLVING A LARGER NUMBER OF PATIENTS, THIS YMP MAY BECOME A COST-EFFECTIVE AND ADVERSE EFFECT-FREE ADJUNCTIVE TREATMENT IN PATIENTS WITH DRUG-RESISTANT EPILEPSIES. 2006