Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-29 @ 10:35 PM
Study NCT ID:
NCT04127604
Status:
COMPLETED
Last Update Posted:
2025-10-22
First Post:
2019-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use 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'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-04', 'size': 11724164, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-10-16T14:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2019-10-14', 'studyFirstSubmitQcDate': '2019-10-14', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief Adherence Rating Scale (BARS)', 'timeFrame': '1 month', 'description': 'The Brief Adherence Rating Scale (BARS) assesses the percentage of missed medication doses over the past month. The total adherence score ranges from 0% to 100% and higher scores indicate greater adherence.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bipolar Disorder', 'Substance Use Disorders', 'Treatment Adherence', 'Veterans', 'Psychosocial intervention'], 'conditions': ['Bipolar Disorder', 'Substance Use Disorders']}, 'descriptionModule': {'briefSummary': 'This trial aims to evaluate the effectiveness of a novel intervention for Veterans 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.', 'detailedDescription': 'This randomized controlled trial will evaluate the effectiveness of a psychosocial intervention designed to improve treatment adherence in Veterans with comorbid bipolar disorder and substance use disorders (BP-SUD) following a psychiatric hospitalization. Participants will be randomized to either the specialized psychosocial intervention or an enhanced safety monitoring program, both as adjuncts to VA treatment as usual. Veterans with BP-SUD will be recruited from the Providence VAMC inpatient psychiatric unit and assessed at baseline and at 3 (mid-treatment), 6 (post-treatment), and 9-month post-discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of a mood disorder\n* Diagnosis of a substance use disorder (drug and/or alcohol)\n* Taking at least one psychiatric medication\n\nExclusion Criteria:\n\n* Unable to speak and read English\n* Younger than age 18'}, 'identificationModule': {'nctId': 'NCT04127604', 'briefTitle': 'Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use Disorders', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use Disorders', 'orgStudyIdInfo': {'id': 'IIR 19-048'}, 'secondaryIdInfos': [{'id': 'IRB-2019-027', 'type': 'OTHER', 'domain': 'Providence VA Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Integrated Treatment Adherence Program for Veterans (ITAP-VA)', '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 for Veterans (ITAP-VA)']}, {'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 for Veterans (ITAP-VA)', 'type': 'BEHAVIORAL', 'description': 'Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.', 'armGroupLabels': ['Integrated Treatment Adherence Program for Veterans (ITAP-VA)']}, {'name': 'Safety Assessment and Follow-up Evaluation (SAFE)', 'type': 'BEHAVIORAL', 'description': 'Measurement-based care assessment and evaluation.', 'armGroupLabels': ['Safety Assessment and Follow-up Evaluation (SAFE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02908-4734', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Providence VA Medical Center, Providence, RI', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Jane Metrik, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Providence VA Medical Center, Providence, RI'}, {'name': 'Brandon A Gaudiano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Providence VA Medical Center, Providence, RI'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'After all data have been collected and the results of the studies published, de-identified data will be made available to other qualified researchers on request.', 'ipdSharing': 'YES', 'description': 'After all data have been collected and the results of the studies published, de-identified data will be made available to other qualified researchers on request. The request will be evaluated by the PI and the Co-Investigators to ensure that it meets reasonable standards of scientific integrity.', 'accessCriteria': 'The request will be evaluated by the PI and the Co-Investigators to ensure that it meets reasonable standards of scientific integrity.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'Providence VA Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}