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

NCT ID: NCT04127604

Last Updated: 2025-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Bipolar Disorder Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Integrated Treatment Adherence Program for Veterans (ITAP-VA)

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

Group Type EXPERIMENTAL

Integrated Treatment Adherence Program for Veterans (ITAP-VA)

Intervention Type BEHAVIORAL

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

Safety Assessment and Follow-up Evaluation (SAFE)

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

Group Type ACTIVE_COMPARATOR

Safety Assessment and Follow-up Evaluation (SAFE)

Intervention Type BEHAVIORAL

Measurement-based care assessment and evaluation.

Interventions

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Integrated Treatment Adherence Program for Veterans (ITAP-VA)

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

Intervention Type BEHAVIORAL

Safety Assessment and Follow-up Evaluation (SAFE)

Measurement-based care assessment and evaluation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Providence VA Medical Center

FED

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jane Metrik, PhD

Role: PRINCIPAL_INVESTIGATOR

Providence VA Medical Center, Providence, RI

Brandon A Gaudiano, PhD

Role: PRINCIPAL_INVESTIGATOR

Providence VA Medical Center, Providence, RI

Locations

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Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB-2019-027

Identifier Type: OTHER

Identifier Source: secondary_id

IIR 19-048

Identifier Type: -

Identifier Source: org_study_id

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