Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
Study NCT ID:
NCT06656650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-28
First Post:
2024-10-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Commensality Groups: a Professional Fulfillment Intervention for Medical Students in Their Clinical Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D012934', 'term': 'Social Isolation'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2024-10-18', 'studyFirstSubmitQcDate': '2024-10-22', 'lastUpdatePostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survey', 'timeFrame': 'Baseline (within one month prior to launch of study), immediately post intervention (within one month after final intervention), approximately 3 months after the final intervention, and approximately 6 months after the final intervention', 'description': 'Survey containing 5 evidence-based measures'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['commensality groups', 'medical students'], 'conditions': ['Professional Fulfillment', 'Burnout', 'Social Isolation or Loneliness']}, 'referencesModule': {'references': [{'pmid': '24515493', 'type': 'BACKGROUND', 'citation': 'West CP, Dyrbye LN, Rabatin JT, Call TG, Davidson JH, Multari A, Romanski SA, Hellyer JM, Sloan JA, Shanafelt TD. Intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):527-33. doi: 10.1001/jamainternmed.2013.14387.'}, {'pmid': '26653297', 'type': 'BACKGROUND', 'citation': 'Shanafelt TD, Hasan O, Dyrbye LN, Sinsky C, Satele D, Sloan J, West CP. Changes in Burnout and Satisfaction With Work-Life Balance in Physicians and the General US Working Population Between 2011 and 2014. Mayo Clin Proc. 2015 Dec;90(12):1600-13. doi: 10.1016/j.mayocp.2015.08.023.'}, {'pmid': '31081911', 'type': 'BACKGROUND', 'citation': 'Hansell MW, Ungerleider RM, Brooks CA, Knudson MP, Kirk JK, Ungerleider JD. Temporal Trends in Medical Student Burnout. Fam Med. 2019 May;51(5):399-404. doi: 10.22454/FamMed.2019.270753.'}, {'pmid': '26695473', 'type': 'BACKGROUND', 'citation': 'Dyrbye L, Shanafelt T. A narrative review on burnout experienced by medical students and residents. Med Educ. 2016 Jan;50(1):132-49. doi: 10.1111/medu.12927.'}, {'pmid': '18765703', 'type': 'BACKGROUND', 'citation': 'Dyrbye LN, Thomas MR, Massie FS, Power DV, Eacker A, Harper W, Durning S, Moutier C, Szydlo DW, Novotny PJ, Sloan JA, Shanafelt TD. Burnout and suicidal ideation among U.S. medical students. Ann Intern Med. 2008 Sep 2;149(5):334-41. doi: 10.7326/0003-4819-149-5-200809020-00008.'}, {'pmid': '16565188', 'type': 'BACKGROUND', 'citation': 'Dyrbye LN, Thomas MR, Shanafelt TD. Systematic review of depression, anxiety, and other indicators of psychological distress among U.S. and Canadian medical students. Acad Med. 2006 Apr;81(4):354-73. doi: 10.1097/00001888-200604000-00009.'}, {'pmid': '27923088', 'type': 'BACKGROUND', 'citation': 'Rotenstein LS, Ramos MA, Torre M, Segal JB, Peluso MJ, Guille C, Sen S, Mata DA. Prevalence of Depression, Depressive Symptoms, and Suicidal Ideation Among Medical Students: A Systematic Review and Meta-Analysis. JAMA. 2016 Dec 6;316(21):2214-2236. doi: 10.1001/jama.2016.17324.'}, {'pmid': '25650824', 'type': 'BACKGROUND', 'citation': 'Dyrbye LN, Eacker A, Durning SJ, Brazeau C, Moutier C, Massie FS, Satele D, Sloan JA, Shanafelt TD. The Impact of Stigma and Personal Experiences on the Help-Seeking Behaviors of Medical Students With Burnout. Acad Med. 2015 Jul;90(7):961-9. doi: 10.1097/ACM.0000000000000655.'}, {'pmid': '24448053', 'type': 'BACKGROUND', 'citation': 'Dyrbye LN, West CP, Satele D, Boone S, Tan L, Sloan J, Shanafelt TD. Burnout among U.S. medical students, residents, and early career physicians relative to the general U.S. population. Acad Med. 2014 Mar;89(3):443-51. doi: 10.1097/ACM.0000000000000134.'}]}, 'descriptionModule': {'briefSummary': 'Medical students are at high risk for burnout, depression, anxiety, suicidal ideation and substance use disorder with burnout seen as a mitigating factor for suicidal ideation. Help-seeking among medical students suffering from burnout is only 30%. The highest rates of burnout among medical students is at the end of their clinical rotations, with estimates of up to 60%. "Commensality groups" have been found to significantly reduce burnout and improve meaning in work by creating opportunity for connection and collegiality among physicians. These groups consist of providing a reimbursed monthly meal with structured questions that generate conversation for the first 15 minutes with 6-8 participants meeting monthly, for six months. Physician participants in Commensality groups maintain these gains one year later.\n\nThe investigators propose to apply the model of Commensality groups to medical students who are launching into their experience clinical practice, and have been on clinical rotations for at least 4 months. The investigators will form randomly assigned groups of 6-8 medical students with 1 resident leader. The resident leader role has been added to encourage compliance with the standardized discussion questions and to avoid the potential negative impact of a "venting" session. The overall intention of this study is to explore whether Commensality groups can increase well-being for medical students in their clerkship years, as it has previously been shown to do for residents and physicians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently a medical student on clerkships at the Keck School of Medicine of the University of Southern California\n\nExclusion Criteria:\n\n* Not currently on a leave of absence, research year, or otherwise not enrolled in the medical school program'}, 'identificationModule': {'nctId': 'NCT06656650', 'briefTitle': 'Commensality Groups: a Professional Fulfillment Intervention for Medical Students in Their Clinical Years', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Commensality Groups: a Professional Fulfillment Intervention for Medical Students in Their Clinical Years', 'orgStudyIdInfo': {'id': 'UP-24-00919'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment group', 'description': 'Participants attend commensality groups', 'interventionNames': ['Behavioral: Commensality groups']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control group', 'description': 'Participants receive no intervention'}], 'interventions': [{'name': 'Commensality groups', 'type': 'BEHAVIORAL', 'description': 'Participants will attend at least 3 out of 6 commensality groups over the course of 6 months.', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maria Juliani, PhD', 'role': 'CONTACT', 'email': 'maria.juliani@med.usc.edu', 'phone': '626-827-1120'}, {'name': 'Chantal Sheridan, PhD', 'role': 'CONTACT', 'email': 'chantal.sheridan@med.usc.edu', 'phone': '626-710-3844'}], 'overallOfficials': [{'name': 'Chantal Sheridan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keck School of Medicine, University of Southern California'}, {'name': 'Maria Juliani, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Keck School of Medicine, University of Southern California'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 3 months and ending 2 years after the publication of results.', 'ipdSharing': 'YES', 'description': 'IPD for all study participants will be shared.', 'accessCriteria': 'Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chantal Sheridan', 'investigatorAffiliation': 'University of Southern California'}}}}