Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-01-09 @ 9:01 PM
Study NCT ID:
NCT03240705
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2017-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing Medical Student Well-being Through Gratitude Journaling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The questionnaires will be coded as to not be able to identify study arm.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-31', 'studyFirstSubmitDate': '2017-05-29', 'studyFirstSubmitQcDate': '2017-08-02', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Well-being', 'timeFrame': '6 weeks after enrollment', 'description': 'Medical student well-being at the end of their surgical rotation. Measured by Perceived Stress Scale (Cohen, 1983)'}, {'measure': 'Well-being', 'timeFrame': '6 weeks after enrollment', 'description': 'Medical student well-being at the end of their surgical rotation. Measured by Satisfaction with Life Scale (Diener, 1985)'}], 'secondaryOutcomes': [{'measure': 'Well-being before and after comparison', 'timeFrame': '6 weeks after enrollment in study', 'description': 'Before and after comparison of well-being by comparing initial and post-intervention questionnaires (Perceived Stress Scale (Cohen, 1983))'}, {'measure': 'Compliance with gratitude journaling', 'timeFrame': '6 weeks after enrollment in study', 'description': "Proportion of empty entries in the student's gratitude journal"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stress', 'Medical education'], 'conditions': ['Stress, Psychological']}, 'referencesModule': {'references': [{'pmid': '28121650', 'type': 'BACKGROUND', 'citation': 'van Dijk I, Lucassen PLBJ, Akkermans RP, van Engelen BGM, van Weel C, Speckens AEM. Effects of Mindfulness-Based Stress Reduction on the Mental Health of Clinical Clerkship Students: A Cluster-Randomized Controlled Trial. Acad Med. 2017 Jul;92(7):1012-1021. doi: 10.1097/ACM.0000000000001546.'}, {'pmid': '15820468', 'type': 'BACKGROUND', 'citation': 'Pettitt BJ. Medical student concerns and fears before their third-year surgical clerkship. Am J Surg. 2005 Apr;189(4):492-6. doi: 10.1016/j.amjsurg.2004.09.017.'}, {'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': '16367493', 'type': 'BACKGROUND', 'citation': 'Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.'}]}, 'descriptionModule': {'briefSummary': "Clerkship causes significant stress to medical students. Some interventions to increase well-being have been described but none have been studied prospectively in this context.\n\nThe primary objective of this study is to examine the effects of gratitude journaling on medical clerks' perceived well-being.\n\nStudents will be randomised to one of two groups: gratitude journaling or no intervention. The participants of the experimental group will be asked to complete an online gratitude journal 3 times per week and will be compared to the participants in the control group.\n\nThe students in both groups will answer a standardised questionnaire evaluating well-being before and after their surgical rotation.\n\nThose randomised to the intervention group will perform gratitude journaling three times a week during their surgical rotation. This activity consists of writing something that made them feel happy during their day.\n\nThose randomised in the control group (no intervention) will proceed with their normal rotation, without additional gratitude journaling.\n\nThe main outcome will be evaluated by comparing the well-being at the end of the surgical rotation as evaluated by a composite well-being assessment scale between both groups.", 'detailedDescription': "Medical education involves 2 years of rotations in different medical and surgical specialties. These cause significant stress to clerks, in particular during the surgery rotation. In other professional fields, mindfulness techniques have shown only small to moderate effect on mental health compared to the control group.\n\nAn alternative approach to increasing well-being is gratitude journaling. A study examining this approach in student populations demonstrated enhanced well-being and life satisfaction.\n\nThe primary objective of this study is to examine the effects of gratitude journaling on medical clerks' perceived well-being.\n\nStudents will be randomised to one of two groups: gratitude journaling or no intervention. The participants of the experimental group will be asked to complete an online gratitude journal 3 times per week and will be compared to the participants in the control group.\n\nThe students in both groups will answer a standardised questionnaire evaluating well-being before and after their surgical rotation.\n\nThose randomised to the intervention group will perform gratitude journaling three times a week during their surgical rotation. This activity consists of writing something that made them feel happy during their day.\n\nThose randomised in the control group (no intervention) will proceed with their normal rotation, without additional gratitude journaling.\n\nThe main outcome will be evaluated by comparing the well-being at the end of the surgical rotation as evaluated by a composite well-being assessment scale between both groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical students at the University of Montreal about to begin their surgical clerkship rotation.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03240705', 'briefTitle': 'Increasing Medical Student Well-being Through Gratitude Journaling', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Randomised Controlled Trial of Gratitude Reporting vs no Intervention on Well-being of Medical Students During Clerkship', 'orgStudyIdInfo': {'id': '16.413'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gratitude journaling', 'description': 'Students perform gratitude journaling 3 times per week on a form. This activity consists of writing elements of their day that brought happiness to them. Can be in keyword form or in sentences.', 'interventionNames': ['Behavioral: Gratitude journaling']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'Students proceed with their surgical clerkship as is standard in our institution.'}], 'interventions': [{'name': 'Gratitude journaling', 'type': 'BEHAVIORAL', 'description': 'Gratitude journaling 3 times a week during surgical rotation', 'armGroupLabels': ['Gratitude journaling']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1J4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Faculté de Médecine de l'Université de Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Erica Patocskai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre hospitalier de l'Université de Montréal (CHUM)"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}