Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-04 @ 8:32 AM
Study NCT ID:
NCT05684120
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2023-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mood Lifters for Undergraduates
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'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Waitlist control model'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2023-01-04', 'studyFirstSubmitQcDate': '2023-01-12', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-18', '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Anxiety', 'Mood Disorders', 'Mental Health Wellness 1', 'Stress']}, 'descriptionModule': {'briefSummary': 'Large-scale, effective, low-cost, and evidence-based programs that can nimbly translate new research discoveries into prevention and care for psychosocial-based problems are urgently needed since the vast majority of people who need evidence-based care do not receive it.\n\nThe purpose of this randomized control trial is to investigate the feasibility and efficacy of a Mood Lifters group template specifically for undergraduate students. Mood Lifters is an effective peer-led program that improves or maintains mental health. It seeks to help people enhance pleasure, engagement, and meaning in their lives while minimizing depression, fear, loneliness, and other negative feelings via a proprietary peer-based program that offers weekly meetings and other flexible support options. One obstacle to providing mental health care in the US is that it is costly to provide one-on-one therapy by a licensed professional. This is particularly true in large group settings with limited resources (counseling centers) and a large need for mental health care, like universities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion:\n\n* undergraduate students\n* at least 18 years of age\n\nExclusion criteria include:\n\n* active suicidal thoughts or behavior\n* active psychosis\n* borderline personality disorder\n* active mania\n* unwillingness to attend all sessions or treatment types (e.g., unwillingness to attend remote)\n* non-undergraduate students.'}, 'identificationModule': {'nctId': 'NCT05684120', 'acronym': 'ML-UP', 'briefTitle': 'Mood Lifters for Undergraduates', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Mood Lifters for Undergraduates Project', 'orgStudyIdInfo': {'id': 'HUM00221612'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Individuals in this arm will take part in the Mood Lifters program immediately after recruitment.', 'interventionNames': ['Behavioral: Mood Lifters for Undergraduates']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist Control Group', 'description': 'Individuals in this arm will be invited to take part in the Mood Lifters program after they complete post-treatment surveys as part of the control group.'}], 'interventions': [{'name': 'Mood Lifters for Undergraduates', 'type': 'BEHAVIORAL', 'otherNames': ['Mood Lifters for College Students'], 'description': 'Participants will need to attend 14 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': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48103', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Patricia J Deldin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Patricia Deldin', 'investigatorAffiliation': 'University of Michigan'}}}}