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Clinical Trials/NCT04127604
NCT04127604
Completed
Not Applicable

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

VA Office of Research and Development1 site in 1 country138 target enrollmentStarted: November 2, 2020Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
138
Locations
1
Primary Endpoint
Brief Adherence Rating Scale (BARS)

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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