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

VA Office of Research and Development

Status: Completed

Conditions: Bipolar Disorder; Substance Use Disorders

Treatments: Behavioral: Integrated Treatment Adherence Program for Veterans (ITAP-VA); Behavioral: Safety Assessment and Follow-up Evaluation (SAFE)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04127604

IIR 19-048

IRB-2019-027 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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138 participants in 2 patient groups

Integrated Treatment Adherence Program for Veterans (ITAP-VA)

Experimental group

Description:

A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.

Treatment:

Behavioral: Integrated Treatment Adherence Program for Veterans (ITAP-VA)

Safety Assessment and Follow-up Evaluation (SAFE)

Active Comparator group

Description:

Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.

Treatment:

Behavioral: Safety Assessment and Follow-up Evaluation (SAFE)