Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-28 @ 12:27 AM
Study NCT ID:
NCT05078450
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2021-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mood Lifters Online for Graduate Students and Young Professionals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2021-09-22', 'studyFirstSubmitQcDate': '2021-09-30', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Health Questionnaire - 9', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Assesses Depressive Symptoms (Range 0-27; higher scores indicate more significant symptoms of depression)'}, {'measure': 'Generalized Anxiety Disorder - 7', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Assesses Anxiety Symptoms (Range 0-21; higher scores indicate more significant symptoms of anxiety)'}, {'measure': 'Perceived Stress Scale', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Assesses Perceived stress (Range 0-40; higher scores indicate more significant perceived stress)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Anxiety Disorders', 'Mood Disorders', 'Mental Illness', 'Stress']}, 'referencesModule': {'references': [{'pmid': '37616078', 'type': 'BACKGROUND', 'citation': 'Garg T, Votta CM, Prakash N, Deldin PJ. An investigation into the effectiveness of Mood Lifters in the context of trauma exposure. Psychol Serv. 2024 Aug;21(3):518-528. doi: 10.1037/ser0000789. Epub 2023 Aug 24.'}, {'pmid': '38540555', 'type': 'BACKGROUND', 'citation': 'Pokowitz EL, Prakash N, Planaj D, Oprandi S, Deldin PJ. Mood Lifters for Graduate Students and Young Adults: A Mixed-Methods Investigation into Mechanisms of Change in Online Group Therapy. Behav Sci (Basel). 2024 Mar 20;14(3):252. doi: 10.3390/bs14030252.'}, {'pmid': '37732972', 'type': 'BACKGROUND', 'citation': 'Prakash N, Votta CM, Deldin PJ. Treatment for graduate students: Blunting the emotional toll of postgraduate education. J Consult Clin Psychol. 2023 Dec;91(12):708-716. doi: 10.1037/ccp0000844. Epub 2023 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'Mood Lifters is a revolutionary mental wellness program that teaches scientifically validated strategies in a supportive group setting. This study will test two new versions of the program designed specifically for graduate students and young professionals.\n\nParticipants will need to attend 12 hour long virtual weekly meetings on Zoom that focus on helpful mental health strategies and skills. Participants will be encourage to practice what the participants learn at home in order to improve their mood or mental wellness. Additionally, participants will complete a series of measures (approx. 1-1.5 hours) prior to, at the end of the program, 1 month after the program and 6 months after the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '32 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants ages 22-32 (must identify as either a graduate student or a young professional)\n\nExclusion Criteria:\n\n* Active suicidality, mania, or psychosis'}, 'identificationModule': {'nctId': 'NCT05078450', 'briefTitle': 'Mood Lifters Online for Graduate Students and Young Professionals', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Mood Lifters Online', 'orgStudyIdInfo': {'id': 'HUM00163570'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Graduate Student Program', 'description': 'This is the graduate student version of the program. The original program has been tailored to this population to meet its specific needs and address its specific concerns.', 'interventionNames': ['Behavioral: Mood Lifters']}, {'type': 'EXPERIMENTAL', 'label': 'Young Professional Program', 'description': 'This is the young professional version of the program. The original program has been tailored to this population to meet its specific needs and address its specific concerns.', 'interventionNames': ['Behavioral: Mood Lifters']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist', 'description': 'This is the waitlist. Participants may be randomly assigned here first. After the typical period fo the intervention on the waitlist (12 weeks), these participants will be invited to join the arm which they are most appropriate for (i.e., graduate student or young professional).'}], 'interventions': [{'name': 'Mood Lifters', 'type': 'BEHAVIORAL', 'description': 'Participants will need to attend 12 hour long virtual weekly meetings on Zoom that focus on helpful mental health strategies and skills. Participants will be encourage to practice what they learn at home in order to improve their mood or mental wellness.', 'armGroupLabels': ['Graduate Student Program', 'Young Professional Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48103', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychology', 'investigatorFullName': 'Patricia Deldin', 'investigatorAffiliation': 'University of Michigan'}}}}