Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT04636151
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2020-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
E-Manage: A Brief mHelath Intervention for University Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059020', 'term': 'Suicidal Ideation'}], 'ancestors': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-24', 'size': 209095, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-03T14:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2020-11-13', 'studyFirstSubmitQcDate': '2020-11-13', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in momentary levels of self-reported distress', 'timeFrame': '8 week study period', 'description': 'Assessed via smartphone assessments'}], 'secondaryOutcomes': [{'measure': 'Change in momentary levels of suicidal thinking', 'timeFrame': '8 week study period', 'description': 'Assessed via smartphone assessments'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Distress, Emotional', 'Suicidal Ideation']}, 'descriptionModule': {'briefSummary': 'This study is a two-part transdiagnostic psychological intervention aimed to help people respond to negative emotion and emotional distress in more adaptive ways using a technology called "ecological momentary intervention" (or EMI) that delivers intervention content using a smartphone app. Participants in this study will be Rutgers students recruited through-or currently affiliated with - Counseling, Alcohol and Other Drug Assistance Program \\& Psychiatric Services (CAPS) at Rutgers. Participants will first attend either one-on-one or group telehealth therapy sessions/workshops, where they will learn the therapeutic skills that are part of the study. Then, they will complete up to 8 weeks of smartphone monitoring that involves assessments and opportunities to practice the skills learned in therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age 18 years or older\n* Matriculated at Rutgers during Fall of 2020 (on campus and/or remote)\n* Currently residing in US\n* Willingness to follow study requirements, as evidenced by an ability to provide written informed consent and read, understand, and complete the study procedures\n* iOS and Android smartphone compatible with MetricWire. Nearly all phones since 2014 are compatible\n\nExclusion Criteria\n\n* Non-English speaking\n* Unable to understand or provide informed consent'}, 'identificationModule': {'nctId': 'NCT04636151', 'briefTitle': 'E-Manage: A Brief mHelath Intervention for University Students', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'E-Manage: A Brief mHelath Intervention for University Students', 'orgStudyIdInfo': {'id': 'Pro2020002347'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individual Treatment', 'description': 'Participants will have up to three individual sessions with a study therapist. One or more treatment modules will be presented in each session.', 'interventionNames': ['Behavioral: Ecological momentary intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Group Treatment', 'description': 'Participants will have up to three group sessions with a study therapist. One or more treatment modules will be presented in each session.', 'interventionNames': ['Behavioral: Ecological momentary intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Workshops', 'description': 'Participants will have one workshop with a study therapist. All three treatment modules will be presented in one session.', 'interventionNames': ['Behavioral: Ecological momentary intervention']}], 'interventions': [{'name': 'Ecological momentary intervention', 'type': 'BEHAVIORAL', 'description': 'Content of this intervention is based on pre-established transdiagnostic protocols for addressing the negative emotion associated with suicidal thoughts and behaviors.', 'armGroupLabels': ['Group Treatment', 'Individual Treatment', 'Workshops']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08854', 'city': 'Piscataway', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Counseling, Alcohol and Other Drug Assistance Program & Psychiatric Services (CAPS)', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}], 'overallOfficials': [{'name': 'Evan Kleiman, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, The State University of New Jersey'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF'], 'timeFrame': 'We will share the informed consent after the final participant has enrolled. We will share de-identified data one year after the study is finished.', 'ipdSharing': 'YES', 'description': 'We will share the informed consent and de-identified data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Evan M. Kleiman, Ph.D.', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}