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

September 20, 2023 updated by: VA Office of Research and Development
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02908-4734
        • Recruiting
        • Providence VA Medical Center, Providence, RI
        • Contact:
        • Principal Investigator:
          • Jane Metrik, PhD
        • Principal Investigator:
          • Brandon A Gaudiano, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Integrated Treatment Adherence Program for Veterans (ITAP-VA)
Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.
Active Comparator: Safety Assessment and Follow-up Evaluation (SAFE)
Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.
Behavioral: Safety Assessment and Follow-up Evaluation (SAFE)
Measurement-based care assessment and evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

Providence VA Medical Center

Investigators

  • Principal Investigator: Jane Metrik, PhD, Providence VA Medical Center, Providence, RI
  • Principal Investigator: Brandon A Gaudiano, PhD, Providence VA Medical Center, Providence, RI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2020

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

October 14, 2019

First Submitted That Met QC Criteria

October 14, 2019

First Posted (Actual)

October 15, 2019

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 19-048
  • IRB-2019-027 (Other Identifier: Providence VA Medical Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After all data have been collected and the results of the studies published, de-identified data will be made available to other qualified researchers on request. The request will be evaluated by the PI and the Co-Investigators to ensure that it meets reasonable standards of scientific integrity.

IPD Sharing Time Frame

After all data have been collected and the results of the studies published, de-identified data will be made available to other qualified researchers on request.

IPD Sharing Access Criteria

The request will be evaluated by the PI and the Co-Investigators to ensure that it meets reasonable standards of scientific integrity.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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