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NCT04127604 Clinical Trial

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

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04127604
Other study ID # IIR 19-048
Secondary ID IRB-2019-027
Status Recruiting
Phase N/A
First received
Last updated
Start date November 2, 2020
Est. completion date January 1, 2025

Study information
Verified date September 2023
Source VA Office of Research and Development
Contact Jane Metrik, PhD
Phone (401) 273-7100
Email Jane.Metrik@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 140
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Integrated Treatment Adherence Program for Veterans (ITAP-VA)
Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.
• Safety Assessment and Follow-up Evaluation (SAFE)
Measurement-based care assessment and evaluation.

Locations
Country Name City State
United States Providence VA Medical Center, Providence, RI Providence Rhode Island

Sponsors (2)
Lead Sponsor Collaborator
VA Office of Research and Development Providence VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 1 month
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