Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-03-11 @ 12:56 AM
Study NCT ID:
NCT04202393
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2019-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention for Comorbid Substance Use and Bipolar Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)', 'timeFrame': '6 months', 'description': 'The Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) assesses depressive symptom severity. Total scores range from 0 to 27 and higher scores indicated higher symptom severity.'}, {'measure': 'Clinician-Administered Rating Scale for Mania (CARS-M)', 'timeFrame': '6 months', 'description': 'The Clinician-Administered Rating Scale for Mania (CARS-M) assesses mania symptom severity. Total scores range from 0 to 50 and higher scores indicated higher symptom severity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bipolar Disorder', 'Substance Use Disorders']}, 'descriptionModule': {'briefSummary': 'This trial aims to evaluate the effectiveness of a novel intervention for patients with co-occurring bipolar and substance use disorders following a psychiatric hospitalization. Half of the participants will receive a specialized psychosocial intervention program, while the other half will receive an enhanced safety monitoring program, both provided in addition to their routine care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Diagnosis of a bipolar-spectrum disorder\n* Diagnosis of a substance use disorder\n* Taking at least one mood-stabilizing medication\n\nExclusion:\n\n* Unable to speak and read English\n* Younger than age 18'}, 'identificationModule': {'nctId': 'NCT04202393', 'acronym': 'ITAP', 'briefTitle': 'Intervention for Comorbid Substance Use and Bipolar Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Butler Hospital'}, 'officialTitle': 'RCT to Improve Post-Hospital Treatment Adherence for Comorbid Substance Use and Bipolar Disorders', 'orgStudyIdInfo': {'id': '1370188-2'}, 'secondaryIdInfos': [{'id': 'R01MH122870', 'link': 'https://reporter.nih.gov/quickSearch/R01MH122870', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Integrated Treatment Adherence Program (ITAP)', 'description': 'A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.', 'interventionNames': ['Behavioral: Integrated Treatment Adherence Program (ITAP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Safety Assessment and Follow-up Evaluation (SAFE)', 'description': 'Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.', 'interventionNames': ['Behavioral: Safety Assessment and Follow-up Evaluation (SAFE)']}], 'interventions': [{'name': 'Integrated Treatment Adherence Program (ITAP)', 'type': 'BEHAVIORAL', 'description': 'Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.', 'armGroupLabels': ['Integrated Treatment Adherence Program (ITAP)']}, {'name': 'Safety Assessment and Follow-up Evaluation (SAFE)', 'type': 'BEHAVIORAL', 'description': 'Enhanced assessment and evaluation with clinician feedback.', 'armGroupLabels': ['Safety Assessment and Follow-up Evaluation (SAFE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Brandon Gaudiano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Butler Hospital'}, {'name': 'Ivan Miller, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Butler Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Upload to NIMH Data Archive'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butler Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}