Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2026-02-22 @ 3:55 PM
Study NCT ID:
NCT03687450
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2018-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility of a Yoga- and Mindfulness-Based Intervention for Resident Physicians
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jloewenthal@bwh.harvard.edu', 'phone': '6177325500', 'title': 'Julia Loewenthal, MD', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention (Yoga) Arm', 'description': "This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.\n\nRISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \\& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.", 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No-treatment Control Arm', 'description': 'This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Attending the Yoga Program', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Yoga) Arm', 'description': "This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.\n\nRISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \\& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."}, {'id': 'OG001', 'title': 'No-treatment Control Arm', 'description': 'This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '25.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-program', 'description': 'Participants were ask to rate the feasibility of attending the yoga program on a visual analogue scale from 0 (not at all feasible) to 100 (very feasible). Only the intervention group rated feasibility since the control group was a waitlist control group and did not attend the program. The standard deviation of the mean score was calculated.', 'unitOfMeasure': 'visual analogue scale, 0 to 100', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed included those in the intervention group who completed any follow-up timepoint, including post-program and/or two-month follow-up. Since the waitlist control group did not attend the program, they were not asked to assess feasibility.'}, {'type': 'SECONDARY', 'title': 'Difference in Burnout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Yoga) Arm', 'description': "This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.\n\nRISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \\& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."}, {'id': 'OG001', 'title': 'No-treatment Control Arm', 'description': 'This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.23', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '6.33', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Post-program', 'categories': [{'measurements': [{'value': '5.65', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '6.83', 'spread': '0.66', 'groupId': 'OG001'}]}]}, {'title': '2-month follow-up', 'categories': [{'measurements': [{'value': '5.72', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '6.43', 'spread': '0.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-program and 2-month follow-up', 'description': 'Maslach Burnout Inventory (short form, 2 items) - scores from 0-12; higher is more burnout', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Professional Fulfillment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Yoga) Arm', 'description': "This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.\n\nRISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \\& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."}, {'id': 'OG001', 'title': 'No-treatment Control Arm', 'description': 'This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.70', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Post-program', 'categories': [{'measurements': [{'value': '1.35', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': '2-month follow-up', 'categories': [{'measurements': [{'value': '1.38', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '1.56', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'Professional Fulfillment Index (PFI; 16 items) - scores from 0-4 for professional fulfillment scale; higher is more fulfillment', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Resident Well-being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Yoga) Arm', 'description': "This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.\n\nRISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \\& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."}, {'id': 'OG001', 'title': 'No-treatment Control Arm', 'description': 'This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.19', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '4.08', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Post-program', 'categories': [{'measurements': [{'value': '3.15', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '3.62', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': '2-month follow-up', 'categories': [{'measurements': [{'value': '3.40', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '3.25', 'spread': '0.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'Resident Well-Being Index (7 items) - scores from 0-7; higher is worse wellbeing', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Resilience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Yoga) Arm', 'description': "This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.\n\nRISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \\& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."}, {'id': 'OG001', 'title': 'No-treatment Control Arm', 'description': 'This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '70.61', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '71.20', 'spread': '3.14', 'groupId': 'OG001'}]}]}, {'title': 'Post-program', 'categories': [{'measurements': [{'value': '76.32', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '72.07', 'spread': '3.02', 'groupId': 'OG001'}]}]}, {'title': '2-month follow-up', 'categories': [{'measurements': [{'value': '72.61', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '72.43', 'spread': '3.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'Resilience Scale (RS-14; 14 items) - scores from 14-98; higher more resilience', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Mindfulness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Yoga) Arm', 'description': "This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.\n\nRISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \\& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."}, {'id': 'OG001', 'title': 'No-treatment Control Arm', 'description': 'This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '48.54', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '48.60', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'Post-program', 'categories': [{'measurements': [{'value': '54.27', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '49.73', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': '2-month follow-up', 'categories': [{'measurements': [{'value': '51.83', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '48.56', 'spread': '1.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'Five Facet Mindfulness Questionnaire (FFMQ; short form, 15 items) - scores from 15-75; higher score means more mindfulness', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Stress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Yoga) Arm', 'description': "This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.\n\nRISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \\& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."}, {'id': 'OG001', 'title': 'No-treatment Control Arm', 'description': 'This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '19.74', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '20.69', 'spread': '1.88', 'groupId': 'OG001'}]}]}, {'title': 'Post-program', 'categories': [{'measurements': [{'value': '16.15', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '18.23', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': '2-month follow-up', 'categories': [{'measurements': [{'value': '16.52', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '18.88', 'spread': '1.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'Perceived Stress Scale (PSS; 10 items) - scores from 0-40; higher is more stress', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Yoga) Arm', 'description': "This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.\n\nRISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \\& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."}, {'id': 'OG001', 'title': 'No-treatment Control Arm', 'description': 'This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.56', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '7.15', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': 'Post-program', 'categories': [{'measurements': [{'value': '6.48', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '7.23', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': '2-month follow-up', 'categories': [{'measurements': [{'value': '7.24', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '7.81', 'spread': '0.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'Patient Reported Outcomes Measurement Information System (PROMIS) Depression (short form: depression-4) - scores from 4-20, higher is more depression', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Sleep Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Yoga) Arm', 'description': "This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.\n\nRISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \\& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."}, {'id': 'OG001', 'title': 'No-treatment Control Arm', 'description': 'This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.38', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '11.62', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Post-program', 'categories': [{'measurements': [{'value': '8.73', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '9.92', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': '2-month follow-up', 'categories': [{'measurements': [{'value': '8.96', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '8.50', 'spread': '1.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'PROMIS Sleep Disturbance (short form, 4 items) - scores from 4-20, higher is more sleep disturbance', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Yoga) Arm', 'description': "This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.\n\nRISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \\& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."}, {'id': 'OG001', 'title': 'No-treatment Control Arm', 'description': 'This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.65', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '10.00', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'Post-program', 'categories': [{'measurements': [{'value': '8.54', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '9.15', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': '2-month follow-up', 'categories': [{'measurements': [{'value': '8.96', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '7.94', 'spread': '0.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety (short form: anxiety-4) - scores from 4-20, higher is more anxiety', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Differences in Professional Fulfillment - Burnout Sub-Item', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Yoga) Arm', 'description': "This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.\n\nRISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \\& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."}, {'id': 'OG001', 'title': 'No-treatment Control Arm', 'description': 'This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.26', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Post-program', 'categories': [{'measurements': [{'value': '2.47', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '2.13', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': '2-month follow-up', 'categories': [{'measurements': [{'value': '2.31', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '2.02', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'Professional Fulfillment Index (PFI; 16 items) - scores from 0-4 for the burnout scale; higher is more burnout', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention (Yoga) Arm', 'description': "This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.\n\nRISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \\& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."}, {'id': 'FG001', 'title': 'No-treatment Control Arm', 'description': 'This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Post-Program Follow-Up', 'achievements': [{'comment': '1 withdrew, 9 lost to follow-up', 'groupId': 'FG000', 'numSubjects': '28'}, {'comment': '3 lost to follow-up', 'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Two-month Follow-up', 'achievements': [{'comment': '2 lost to follow-up', 'groupId': 'FG000', 'numSubjects': '26'}, {'comment': '2 lost to follow-up (N.B. 1 participant completed 2-month follow-up but not post-program follow-up)', 'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention (Yoga) Arm', 'description': "This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.\n\nRISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \\& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum."}, {'id': 'BG001', 'title': 'No-treatment Control Arm', 'description': 'This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '33'}, {'value': '29.1', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '33'}, {'value': '29.2', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '33'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Year in Training', 'classes': [{'categories': [{'title': '1st year', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '2nd year', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '3rd year', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '4th year and above', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Specialty', 'classes': [{'categories': [{'title': 'Internal Medicine', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'OB/GYN', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Diagnostic Radiology', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Emergency Medicine', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Psychiatry', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Medicine-Pediatrics', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Anesthesiology', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Physical Medicine & Rehabilitation', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants included in analysis were those who completed ANY follow-up survey (post-program or two-month follow-up). This includes 28 who completed post-program follow-up in intervention arm and 16 who completed two-month follow-up in control arm.'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2019-05-04', 'size': 274225, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-30T11:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2018-03-27', 'resultsFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2018-09-26', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-08', 'studyFirstPostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Attending the Yoga Program', 'timeFrame': 'Post-program', 'description': 'Participants were ask to rate the feasibility of attending the yoga program on a visual analogue scale from 0 (not at all feasible) to 100 (very feasible). Only the intervention group rated feasibility since the control group was a waitlist control group and did not attend the program. The standard deviation of the mean score was calculated.'}], 'secondaryOutcomes': [{'measure': 'Difference in Burnout', 'timeFrame': 'Post-program and 2-month follow-up', 'description': 'Maslach Burnout Inventory (short form, 2 items) - scores from 0-12; higher is more burnout'}, {'measure': 'Difference in Professional Fulfillment', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'Professional Fulfillment Index (PFI; 16 items) - scores from 0-4 for professional fulfillment scale; higher is more fulfillment'}, {'measure': 'Difference in Resident Well-being', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'Resident Well-Being Index (7 items) - scores from 0-7; higher is worse wellbeing'}, {'measure': 'Difference in Resilience', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'Resilience Scale (RS-14; 14 items) - scores from 14-98; higher more resilience'}, {'measure': 'Difference in Mindfulness', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'Five Facet Mindfulness Questionnaire (FFMQ; short form, 15 items) - scores from 15-75; higher score means more mindfulness'}, {'measure': 'Difference in Stress', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'Perceived Stress Scale (PSS; 10 items) - scores from 0-40; higher is more stress'}, {'measure': 'Difference in Depression', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'Patient Reported Outcomes Measurement Information System (PROMIS) Depression (short form: depression-4) - scores from 4-20, higher is more depression'}, {'measure': 'Difference in Sleep Quality', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'PROMIS Sleep Disturbance (short form, 4 items) - scores from 4-20, higher is more sleep disturbance'}, {'measure': 'Difference in Anxiety', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety (short form: anxiety-4) - scores from 4-20, higher is more anxiety'}, {'measure': 'Differences in Professional Fulfillment - Burnout Sub-Item', 'timeFrame': 'Baseline, post-program, and 2-month follow-up', 'description': 'Professional Fulfillment Index (PFI; 16 items) - scores from 0-4 for the burnout scale; higher is more burnout'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['yoga', 'mindfulness', 'meditation', 'resident', 'residency'], 'conditions': ['Burnout, Professional', 'Anxiety', 'Depression', 'Stress']}, 'referencesModule': {'references': [{'pmid': '7850498', 'type': 'BACKGROUND', 'citation': 'Wagnild GM, Young HM. Development and psychometric evaluation of the Resilience Scale. J Nurs Meas. 1993 Winter;1(2):165-78.'}, {'pmid': '16443717', 'type': 'BACKGROUND', 'citation': 'Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.'}, {'pmid': '22623334', 'type': 'BACKGROUND', 'citation': 'Baer RA, Carmody J, Hunsinger M. Weekly change in mindfulness and perceived stress in a mindfulness-based stress reduction program. J Clin Psychol. 2012 Jul;68(7):755-65. doi: 10.1002/jclp.21865. Epub 2012 May 23.'}, {'pmid': '27078186', 'type': 'BACKGROUND', 'citation': 'Gu J, Strauss C, Crane C, Barnhofer T, Karl A, Cavanagh K, Kuyken W. Examining the factor structure of the 39-item and 15-item versions of the Five Facet Mindfulness Questionnaire before and after mindfulness-based cognitive therapy for people with recurrent depression. Psychol Assess. 2016 Jul;28(7):791-802. doi: 10.1037/pas0000263. Epub 2016 Apr 14.'}, {'pmid': '6668417', 'type': 'BACKGROUND', 'citation': 'Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.'}, {'pmid': '19802645', 'type': 'BACKGROUND', 'citation': 'West CP, Dyrbye LN, Sloan JA, Shanafelt TD. Single item measures of emotional exhaustion and depersonalization are useful for assessing burnout in medical professionals. J Gen Intern Med. 2009 Dec;24(12):1318-21. doi: 10.1007/s11606-009-1129-z. Epub 2009 Oct 3.'}, {'pmid': '22362127', 'type': 'BACKGROUND', 'citation': 'West CP, Dyrbye LN, Satele DV, Sloan JA, Shanafelt TD. Concurrent validity of single-item measures of emotional exhaustion and depersonalization in burnout assessment. J Gen Intern Med. 2012 Nov;27(11):1445-52. doi: 10.1007/s11606-012-2015-7. Epub 2012 Feb 24.'}, {'pmid': '29196982', 'type': 'BACKGROUND', 'citation': 'Trockel M, Bohman B, Lesure E, Hamidi MS, Welle D, Roberts L, Shanafelt T. A Brief Instrument to Assess Both Burnout and Professional Fulfillment in Physicians: Reliability and Validity, Including Correlation with Self-Reported Medical Errors, in a Sample of Resident and Practicing Physicians. Acad Psychiatry. 2018 Feb;42(1):11-24. doi: 10.1007/s40596-017-0849-3. Epub 2017 Dec 1.'}, {'pmid': '16004657', 'type': 'BACKGROUND', 'citation': 'Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.'}, {'pmid': '24931848', 'type': 'BACKGROUND', 'citation': 'Pilkonis PA, Yu L, Dodds NE, Johnston KL, Maihoefer CC, Lawrence SM. Validation of the depression item bank from the Patient-Reported Outcomes Measurement Information System (PROMIS) in a three-month observational study. J Psychiatr Res. 2014 Sep;56:112-9. doi: 10.1016/j.jpsychires.2014.05.010. Epub 2014 May 29.'}, {'pmid': '3397865', 'type': 'BACKGROUND', 'citation': 'Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.'}, {'pmid': '22250775', 'type': 'BACKGROUND', 'citation': 'Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. doi: 10.1080/15402002.2012.636266.'}, {'pmid': '24701315', 'type': 'BACKGROUND', 'citation': 'Dyrbye LN, Satele D, Sloan J, Shanafelt TD. Ability of the physician well-being index to identify residents in distress. J Grad Med Educ. 2014 Mar;6(1):78-84. doi: 10.4300/JGME-D-13-00117.1.'}]}, 'descriptionModule': {'briefSummary': "The investigators aim to initiate and complete the first investigation of the effect of a yoga-based program on resident physicians' psychological health using a randomized controlled trial to assess feasibility of the program in this population and measure outcomes across several domains. To meet the goals of the proposed project the investigators have identified 3 specific aims:\n\nSpecific Aim 1: Assess the acceptability and feasibility of the yoga program through measuring participation and conducting standardized interviews with a subset of yoga participants.\n\nSpecific Aim 2: Evaluate the effect of the yoga program on resident physicians' stress, burnout, resilience, mindfulness, mood, depression, anxiety, and sleep quality using quantitative self-report measures.\n\nSpecific Aim 3. Examine whether outcome measures were perceived as relevant to the participants' work environment and were not burdensome as to the length and content of the program.", 'detailedDescription': 'The project will implement a single group mixed-methods randomized controlled trial to investigate the impact of the 6-week RISE program on psychological health in Longwood medical area residents. The RISE program is an existing standardized yoga program at Kripalu that will be adapted for residents in a 60-90-minute, once-weekly class for six weeks. Participants will be randomized to either the RISE yoga program or a no-treatment control group. Participants randomized to the RISE program will also be instructed to maintain a short 10-15-minute daily home yoga practice. Sessions will be lead by experienced instructors from Kripalu and will be held in the Longwood medical area. Self-report outcomes will be assessed at baseline, at program completion (post-program), at 2-month follow-up, and at 6-month follow-up.\n\nParticipants will include resident physicians at Longwood medical area hospitals. The only exclusion criterion is having practiced yoga, meditation, tai chi, qigong, or another mind-body practice at least 25 hours or more in the past 6 months. Participants must be willing not to practice mind-body programs other than the treatment protocol during the intervention. We plan to enroll up to 200 participants with a goal of at least 60 participants with a 2:1 ratio of participants randomized to yoga to participants randomized to control. The control group will receive one session of RISE after their participation in the trial is complete.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals enrolled in residency programs at Brigham and Women's Hospital, Beth Israel Deaconess, Boston Children's Hospital, or a Harvard Combined Residency Program\n* Individuals must be willing to not practice mind-body programs other than the intervention during the treatment protocol\n* Must be proficient in English\n\nExclusion Criteria:\n\n* Individuals who currently practice yoga, meditation, tai chi, qigong, and other mind-body practices more than 25 hours in the past 6 months"}, 'identificationModule': {'nctId': 'NCT03687450', 'briefTitle': 'Feasibility of a Yoga- and Mindfulness-Based Intervention for Resident Physicians', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Feasibility of a Yoga- and Mindfulness-Based Intervention for Resident Physicians', 'orgStudyIdInfo': {'id': '2017P002372'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (Yoga) Arm', 'description': 'Received a weekly 60-minute yoga-based class over 6 weeks with direction for a 5-10 minute daily home practice.', 'interventionNames': ['Behavioral: RISE yoga-based program']}, {'type': 'NO_INTERVENTION', 'label': 'No-treatment Control Arm', 'description': 'Waitlist control-- group received one session of yoga-based class at the completion of the study.'}], 'interventions': [{'name': 'RISE yoga-based program', 'type': 'BEHAVIORAL', 'description': "The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \\& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.", 'armGroupLabels': ['Intervention (Yoga) Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Sat Bir Khalsa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Kripalu Center for Yoga and Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Sat Bir Khalsa, PhD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}