Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-04 @ 4:41 AM
Study NCT ID:
NCT04584268
Status:
COMPLETED
Last Update Posted:
2020-10-12
First Post:
2020-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'cluster randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2020-07-23', 'studyFirstSubmitQcDate': '2020-10-05', 'lastUpdatePostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maslach Burnout Inventory (MBI)', 'timeFrame': '1 year', 'description': 'burnout score on MBI (score range 0-132); based on three components: emotional exhaustion, depersonalization, and personal accomplishment)'}, {'measure': 'feasibility of intervention in graduate medical education', 'timeFrame': '1 year', 'description': 'ability to insert into the curriculum without barriers or disruption of other education activities, assessed by interviews from residency leadership'}], 'secondaryOutcomes': [{'measure': 'evaluation of intervention', 'timeFrame': '1 year', 'description': 'survey to assess opinion of intervention (Likert scale)'}, {'measure': 'effect on mindfulness practice', 'timeFrame': '1 year', 'description': 'survey question to assess pre and post-intervention frequency of practicing mindfulness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['burnout', 'medical residents'], 'conditions': ['Burnout']}, 'descriptionModule': {'briefSummary': 'This was a single-site RCT to assess the effect of a longitudinal mindfulness intervention on burnout for first-year (PGY-1) internal medicine (IM) and pediatrics residents. The primary outcome was Maslach Burnout Inventory MBI) scores at baseline and 12 month follow-up. Secondary outcomes were feasibility and perceived benefit of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Washington University (WUSM) first year residents in internal medicine and pediatrics\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04584268', 'briefTitle': 'Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Randomized Controlled Trial of a Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents', 'orgStudyIdInfo': {'id': '201904014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mindfulness', 'description': '3 30 minute in person interventions as well as promotion and involvement of self-guided meditations on the Insight Timer smart phone application', 'interventionNames': ['Behavioral: mindfulness']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'standard medical resident education', 'interventionNames': ['Other: standard medical education']}], 'interventions': [{'name': 'mindfulness', 'type': 'BEHAVIORAL', 'description': 'in person and smart phone application mindfulness practice', 'armGroupLabels': ['mindfulness']}, {'name': 'standard medical education', 'type': 'OTHER', 'description': 'standard medical education / control', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'protocol and SAP now. CSR upon publication', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in Medicine and Pediatrics', 'investigatorFullName': 'Christopher Prater', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}