Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-01 @ 5:13 PM
Study NCT ID:
NCT06969950
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating an Intervention for Physician Burnout
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One group will receive the intervention (audio-course) to listen during the study and the other group will have access to the audio-course at the end of the study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-02-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2025-03-28', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Level of Work Engagement', 'timeFrame': 'It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).', 'description': '1\\. Job Engagement Questionnaire (18 items). The Job Engagement questionnaire is a validated scale of the 18-item. This scale contains 18 items which are presented on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).'}, {'measure': 'Level of patient-centered care', 'timeFrame': 'It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).', 'description': '2\\. Nursing Workplace Satisfaction Questionnaire (NWSQ - 17). The NWSQ is a validated 17-item self-report measure of patient-centered care with items presented on a 5-point Likert scale ranging from 1 (fully disagree) to 5 (definitely disagree).'}, {'measure': 'Level of organization civic behavior', 'timeFrame': 'It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).', 'description': '3\\. Organizational Civic Behavior Scale (24 items). This questionnaire is a validated 24-item self-report measure of Organizational Civic Scale. Items are rated 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).'}, {'measure': 'Level of physician well-being', 'timeFrame': 'It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).', 'description': '4\\. Physician Well-Being Index (PWBI - 7 items). This questionnaire is a validated 7-item self-report measure of Physician Well-Being. Items are rated 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).'}, {'measure': 'Level of loneliness', 'timeFrame': 'It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).', 'description': '5\\. UCLA 3-Item Loneliness Scale (University California Los Angeles - 3 items). This questionnaire is a validated 3-item self-report measure of Loneliness. Items are rated 10-point Likert-type scale ranging from 1 (least lonely) to 10 (lost lonely).'}, {'measure': 'Level of mindfulness practice', 'timeFrame': 'It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).', 'description': '6\\. Mindful Practice Questionnaire (MIPR-Q - 28 items). This questionnaire is a validated 28-item self-report measure of Mindfulness practice. Items are rated 4-point Likert-type scale ranging from 1 (never/almost never) to 4 for (always/most always).'}, {'measure': 'Elements learned', 'timeFrame': 'It will be collected one time, two weeks after the baseline (post-app). For the sub-group that will attend the online virtual training intervention, it will be collected a second time after 4 months (post online virtual training intervention).', 'description': 'Open question regarding the elements learned with the app and virtual training sessions.'}, {'measure': 'Facilitators', 'timeFrame': 'It will be collected one time, two weeks after the baseline (post-app). For the sub-group that will attend the online training intervention, it will be collected a second time after 4 months (post online training intervention).', 'description': 'Open question regarding the facilitators encountered with the app and virtual training sessions.'}, {'measure': 'Barriers', 'timeFrame': 'It will be collected one time, at two weeks after the baseline (post-app). For the sub-group that will attend the online virtual training, it will be collected a second time after 4 months (post online training intervention).', 'description': 'Open question regarding the barriers encountered with the app and virtual training sessions.'}], 'primaryOutcomes': [{'measure': 'Level of cynicism', 'timeFrame': 'It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).', 'description': 'Maslach Burnout Inventory (MBI) cynicism. The MBI is a validated 22-item self-report measure of risk of burnout. Items are rated on a 7-point Likert scale ranging from 0 (never) to 6 (every day). The investigators will use only one single-item measure of cynicism that was included from the Maslach Burnout Inventory (MBI)-based on the research of West et al., 2009.'}], 'secondaryOutcomes': [{'measure': 'Level of emotional exhaustion', 'timeFrame': 'It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).', 'description': '1.Maslach Burnout Inventory (MBI) emotional exhaustion. The MBI is a validated 22-item self-report measure of risk of burnout. Items are rated on a 7-point Likert scale ranging from 0 (never) to 6 (every day).'}, {'measure': 'Level of anxiety', 'timeFrame': 'It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).', 'description': '2.Generalized Anxiety Disorder 7-items (GAD-7). The GAD-7 is a validated 7-item measure of anxiety rated on a 4-point Likert scale ranging from 0 (Not at all sure) to 3 (Nearly every day).'}, {'measure': 'Level of depression', 'timeFrame': 'It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).', 'description': 'Patient Health Questionnaire 2-item scale (PHQ-2). The PHQ-2 is a validated 2-item self-report measure of depression. Items are rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).'}, {'measure': 'Level of intolerance of uncertainty', 'timeFrame': 'It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).', 'description': '4.Intolerance of Uncertainty 12-item scale (IUS-12). The IUS-12 is a validated 12-item self-report measure of intolerance of uncertainty. Items are rated on a 5-point Likert scale ranging from 1 (not t all).'}, {'measure': 'Level of self-compassion', 'timeFrame': 'It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).', 'description': '5.Self-Compassion Scale. The SCS is a validated 12-item self-report measure of self-compassion on a 5-point Likert scale ranging from 1 (almost never) to 5 (always).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['burnout', 'physicians', 'app-based', 'smarthphone', 'mindfulness'], 'conditions': ['Physician Burnout']}, 'descriptionModule': {'briefSummary': 'The goals of this randomized controlled trial are 1) to test the efficacy of an app-based program in reducing physician burnout vs. no app (control) in 100 physicians; 2) to explore the role of an online live training to augment outcomes and develop an ongoing and sustainable support community with a subsample of physicians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Being a physician\n2. Able to speak English because all study activities will be conducted in English.\n3. 18+ years\n4. Direct patient care\n\nExclusion Criteria:\n\n1\\. If using psychotropic medication - not on a stable dosage at least 6 weeks'}, 'identificationModule': {'nctId': 'NCT06969950', 'briefTitle': 'Evaluating an Intervention for Physician Burnout', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Evaluating an Evidence-Based Intervention for Physician Burnout', 'orgStudyIdInfo': {'id': 'STUDY00000677'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Early App-Delivered Mindfulness Training (MT).', 'description': 'Participants will be asked to utilize the app designed to reduce burnout for 2 weeks', 'interventionNames': ['Other: App-Delivered Mindfulness Training (MT).']}, {'type': 'OTHER', 'label': 'Later App-Delivered Mindfulness Training (MT).', 'description': 'Participants will receive the intervention after the three-month follow-up, not before.', 'interventionNames': ['Other: App-Delivered Mindfulness Training (MT).']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Online Virtual Training', 'description': 'A sub-group of participants will receive the virtual online training after three-month follow-up or directly after the app-based intervention.', 'interventionNames': ['Other: App-Delivered Mindfulness Training (MT).', 'Other: Online Virtual Training']}], 'interventions': [{'name': 'App-Delivered Mindfulness Training (MT).', 'type': 'OTHER', 'description': 'The program is delivered via a smartphone-based platform, which includes 7 mindfulness-based modules of about 15 minutes of brief didactic and experience-based for two weeks', 'armGroupLabels': ['Experimental: Early App-Delivered Mindfulness Training (MT).', 'Experimental: Online Virtual Training', 'Later App-Delivered Mindfulness Training (MT).']}, {'name': 'Online Virtual Training', 'type': 'OTHER', 'description': 'A sub-group of 25 participants, either from the both intervention or control group, the will receive a virtual online training delivered via zoom calls. It is a group session program which includes 4 mindfulness-based sessions of about 60 minutes of brief didactic and experience-based for four weeks.', 'armGroupLabels': ['Experimental: Online Virtual Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lia Antico, PhD', 'role': 'CONTACT', 'email': 'lia_antico@brown.edu', 'phone': '4013280763'}, {'name': 'Lia Antico, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Judson Brewer, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'centralContacts': [{'name': 'Lia Antico, PhD In Neuroscience', 'role': 'CONTACT', 'email': 'lia_antico@brown.edu', 'phone': '+1-401-328-0763'}, {'name': 'Judson Brewer, PhD, MD', 'role': 'CONTACT', 'email': 'judson_brewer@brown.edu'}], 'overallOfficials': [{'name': 'Lia Antico, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}, {'name': 'Joseph Casamassima, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Brown University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}