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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04127604

Enrollment

138

Registered

2019-10-15

Start date

2020-11-02

Completion date

2025-09-30

Last updated

2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Substance Use Disorders

Keywords

Bipolar Disorder, Substance Use Disorders, Treatment Adherence, Veterans, Psychosocial intervention

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.

Interventions

BEHAVIORALIntegrated Treatment Adherence Program for Veterans (ITAP-VA)

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

BEHAVIORALSafety Assessment and Follow-up Evaluation (SAFE)

Measurement-based care assessment and evaluation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026