Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use Disorders

Not Applicable

Recruiting

• Conditions: Bipolar Disorder; Substance Use Disorders
• Interventions: Behavioral: Safety Assessment and Follow-up Evaluation (SAFE); Behavioral: Integrated Treatment Adherence Program for Veterans (ITAP-VA)

• Registration Number: NCT04127604
• Lead Sponsor: VA Office of Research and Development

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-15
• Study Start: 2020-11-02
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Diagnosis of a mood disorder
• Diagnosis of a substance use disorder (drug and/or alcohol)
• Taking at least one psychiatric medication

Exclusion Criteria

• Unable to speak and read English
• Younger than age 18

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Safety Assessment and Follow-up Evaluation (SAFE)	Safety Assessment and Follow-up Evaluation (SAFE)	Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.
Integrated Treatment Adherence Program for Veterans (ITAP-VA)	Integrated Treatment Adherence Program for Veterans (ITAP-VA)	A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.

Primary Outcome Measures

Name	Time	Method
Brief Adherence Rating Scale (BARS)	1 month	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.

Trial Locations

Locations (1)

Providence VA Medical Center, Providence, RI; 🇺🇸 Providence, Rhode Island, United States