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

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.

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Key information

Conditions

Bipolar Disorder Behavior Bipolar and Related Disorders Chemically-Induced Disorders Health Behavior Mental Disorders Mood Disorders Substance Use Disorders Substance-Related Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated Treatment Adherence Program for Veterans (ITAP-VA)

Behavioral

Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.

Safety Assessment and Follow-up Evaluation (SAFE)

Behavioral

Measurement-based care assessment and evaluation.

Primary outcomes

Brief Adherence Rating Scale (BARS)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

Providence VA Medical Center

Registry information

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2025
First posted: Oct 15, 2019
Registry last updated: Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed