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

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT04127604
Collaborator
Providence VA Medical Center (U.S. Fed)
140
Enrollment
1
Location
2
Arms
50
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Integrated Treatment Adherence Program for Veterans (ITAP-VA)
  • Behavioral: Safety Assessment and Follow-up Evaluation (SAFE)
 N/A

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
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use Disorders
Actual Study Start Date :
Nov 2, 2020
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Brief Adherence Rating Scale (BARS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Providence VA Medical Center, Providence, RI Providence Rhode Island United States 02908

Sponsors and Collaborators

  • VA Office of Research and Development
  • Providence VA Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT04127604
Other Study ID Numbers:
  • IIR 19-048
  • IRB-2019-027
First Posted:
Oct 15, 2019
Last Update Posted:
Oct 1, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by VA Office of Research and Development
Bipolar Disorder
Substance Use Disorders
Treatment Adherence
Veterans
Psychosocial intervention
Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Bipolar Disorder

Study Results

No Results Posted as of Oct 1, 2021