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

• ClinicalTrials.gov Identifier: NCT04127604
• Recruitment Status: Recruiting
• First Posted: October 15, 2019
• Last Update Posted: December 22, 2020
• Sponsor: VA Office of Research and Development
• Collaborator: Providence VA Medical Center
• Information provided by (Responsible Party): VA Office of Research and Development

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
Bipolar Disorder; Substance Use Disorders	Behavioral: Integrated Treatment Adherence Program for Veterans (ITAP-VA); Behavioral: Safety Assessment and Follow-up Evaluation (SAFE)	Not Applicable

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 (Clinical Trial)
• Estimated 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: November 2, 2020
• Estimated Primary Completion Date: January 1, 2025
• Estimated Study Completion Date: January 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) [ 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Diagnosis of a bipolar-spectrum disorder
• Diagnosis of a substance use disorder (drug and/or alcohol)
• Taking at least one mood-stabilizing medication

Exclusion Criteria:

• Unable to speak and read English
• Younger than age 18

Contacts and Locations

Contacts

Contact: Jane Metrik, PhD; (401) 273-7100 ext 12024; Jane.Metrik@va.gov

Locations

United States, Rhode Island

Providence VA Medical Center, Providence, RI; Recruiting

Providence, Rhode Island, United States, 02908

Contact: Kimberly Marcolivio, MEd 401-273-7100 ext 13464 Kimberly.Marcolivio@va.gov

Sub-Investigator: Brandon A Gaudiano, PhD

Principal Investigator: Jane Metrik, PhD

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

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT04127604
• Other Study ID Numbers: IIR 19-048; IRB-2019-027 ( Other Identifier: Providence VA Medical Center )
• First Posted: October 15, 2019
• Last Update Posted: December 22, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Informed Consent Form (ICF)
• 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.
• Access Criteria: The request will be evaluated by the PI and the Co-Investigators to ensure that it meets reasonable standards of scientific integrity.

• 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; Pathologic Processes; Bipolar and Related Disorders; Mental Disorders; Chemically-Induced Disorders