Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT06003920
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2023-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes of a Small Process Group on Medical Students' Grit, Resilience, and Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-24', 'size': 146821, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-15T18:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'Interventionist was blinded to which group participants were also research participants.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-15', 'studyFirstSubmitDate': '2023-07-31', 'studyFirstSubmitQcDate': '2023-08-15', 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Stress Scale-14', 'timeFrame': '34 weeks', 'description': 'Stress measured on a 0-56 scale; higher number means more stress. Each of the 14 questions is measured on a 0-4 scale of 0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often.'}, {'measure': 'Connor-Davidson Resilience Scale-25', 'timeFrame': '34 weeks', 'description': 'Resilience is measured on this 25-item scale, with higher numbers meaning more resilience. The score can range between 0 and 100. Each item has anchors from 0-4.'}, {'measure': 'The Grit Scale', 'timeFrame': '34 weeks', 'description': 'The original 12-item grit scale was used to measure grit; each items is rated 1-5, then scores are summed and divided by 12, so the final score is between 1-5. Higher scores mean more grit.'}], 'secondaryOutcomes': [{'measure': 'Medication or diagnosis change', 'timeFrame': '34 weeks', 'description': 'Change in anti-depression, anti-anxiety, or other mental health medications or diagnoses on a binary yes/no scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['medical students', 'stress', 'grit', 'resilience'], 'conditions': ['Stress']}, 'descriptionModule': {'briefSummary': 'The incidence of burnout and mental ill-health begins very early in medical school and continues to be high throughout training. Medical students are under high amounts of stress, which often becomes chronic, and can lead to both physical and psychological issues as a student, resident, and physician. Chronic stress and burnout in medical students are not a new phenomenon, but recent research has highlighted the worsening mental health of medical students, with as high as three-quarters of students reporting mental ill-health. It is vital that ways are found to reduce burnout and assist in improving the mental health of medical students. This quasi-experimental study aimed to assess the effect of a small process group vs. a control group of preclinical medical students on their stress, resilience, and grit.', 'detailedDescription': "The investigators assessed the effects of a year-long small process group intervention, led by a psychiatrist, which aimed to improve self-awareness, mindfulness, and resilience in first and second-year medical students. Students self-selected into the process group, and the same number were randomly recruited as controls from the rest of the preclinical student body. The psychiatrist who led the groups was blinded to student participation in the study. Students in the process and control groups were surveyed with the Perceived Stress Scale, the Connor-Davidson Resilience Scale, and the Grit Scale in September 2022, and again after nine months and 25 sessions, in May 2023, after the academic year. Statistical analysis was done with R Studio. Bandura's theory of self-efficacy was used to conceptualize the study. Recruitment was done by email, as was data collection. The intervention included guided exploration of the psychodynamic process, group dynamic theory, cognitive behavioral therapy, dialectical behavioral therapy, boundaries, and empathy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The participant must be an enrolled student at the College of Osteopathic Medicine of the Pacific-NW\n2. Participant must be in their first or second year of medical school\n3. Participant must be at least 18 years of age\n4. Participant must self-select into either the intervention group or control group\n5. Participant must sign informed consent\n\nExclusion Criteria:\n\n1. Data will be excluded if a student goes on a LOA during the course of the year\n2. Data will be excluded if a student does not attend a minimum of 12 out of 25 small group sessions\n3. Student does not give informed consent\n4. Student withdraws consent at any time'}, 'identificationModule': {'nctId': 'NCT06003920', 'briefTitle': "Outcomes of a Small Process Group on Medical Students' Grit, Resilience, and Stress", 'organization': {'class': 'OTHER', 'fullName': 'Western University of Health Sciences'}, 'officialTitle': "Outcomes of a Small Process Group on Medical Students' Grit, Resilience, and Stress: A Quasi-experimental Pilot Study", 'orgStudyIdInfo': {'id': '1902099'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Process Group', 'description': 'Medical students enrolled in the small process group, led by psychiatrist.', 'interventionNames': ['Behavioral: Process group']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Medical students from the same cohorts, not enrolled in the small process group.'}], 'interventions': [{'name': 'Process group', 'type': 'BEHAVIORAL', 'description': 'The medical student process group served as a space for students to gain increased self-awareness through guided exploration of the psychodynamic processes.', 'armGroupLabels': ['Process Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97355', 'city': 'Lebanon', 'state': 'Oregon', 'country': 'United States', 'facility': 'College of Osteopathic Medicine of the Pacific - Northwest', 'geoPoint': {'lat': 44.53651, 'lon': -122.90703}}], 'overallOfficials': [{'name': 'Edie L Sperling, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University of Health Sciences'}]}, 'ipdSharingStatementModule': {'url': 'https://www.kaggle.com/datasets/esperling/stress-grit-and-resilience-in-medical-students', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Study protocol and SAP will be shared with results. Informed consent is shared here.', 'ipdSharing': 'YES', 'description': 'All anonymized demographic and outcome data will be shared in an open-access data repository.', 'accessCriteria': 'Open access.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor and Vice-Chair, Medical Anatomical Sciences', 'investigatorFullName': 'Edie Sperling', 'investigatorAffiliation': 'Western University of Health Sciences'}}}}