An interventional study of Integrated Treatment Adherence Program for Veterans (ITAP-VA) and Safety Assessment and Follow-up Evaluation (SAFE) in Bipolar Disorder and Substance Use Disorders, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-22.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
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.
1,601 studies on the registry are indexed under Bipolar Disorder; 255 are open to participants now.
This study's enrollment of 138 is above the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.
Behavioral: Integrated Treatment Adherence Program for Veterans (ITAP-VA)
Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.
Behavioral: Safety Assessment and Follow-up Evaluation (SAFE)
Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.
Measurement-based care assessment and evaluation.
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.
Time frame: 1 month
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Icf
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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VA Office of Research and Development