Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use Disorders
2 other identifiers
interventional
138
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2019
CompletedFirst Posted
Study publicly available on registry
October 15, 2019
CompletedStudy Start
First participant enrolled
November 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedOctober 22, 2025
October 1, 2025
4.9 years
October 14, 2019
October 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brief Adherence Rating Scale (BARS)
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.
1 month
Study Arms (2)
Integrated Treatment Adherence Program for Veterans (ITAP-VA)
EXPERIMENTALA combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.
Safety Assessment and Follow-up Evaluation (SAFE)
ACTIVE COMPARATOREnhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.
Interventions
Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.
Measurement-based care assessment and evaluation.
Eligibility Criteria
You may qualify if:
- Diagnosis of a mood disorder
- Diagnosis of a substance use disorder (drug and/or alcohol)
- Taking at least one psychiatric medication
You may not qualify if:
- Unable to speak and read English
- Younger than age 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jane Metrik, PhD
Providence VA Medical Center, Providence, RI
- PRINCIPAL INVESTIGATOR
Brandon A Gaudiano, PhD
Providence VA Medical Center, Providence, RI
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2019
First Posted
October 15, 2019
Study Start
November 2, 2020
Primary Completion
September 30, 2025
Study Completion
September 30, 2025
Last Updated
October 22, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- 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.
- Access Criteria
- The request will be evaluated by the PI and the Co-Investigators to ensure that it meets reasonable standards of scientific integrity.
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.