search
Back to results

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

Primary Purpose

Bipolar Disorder, Substance Use Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated Treatment Adherence Program for Veterans (ITAP-VA)
Safety Assessment and Follow-up Evaluation (SAFE)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder, Substance Use Disorders, Treatment Adherence, Veterans, Psychosocial intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Providence VA Medical Center, Providence, RIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Integrated Treatment Adherence Program for Veterans (ITAP-VA)

Safety Assessment and Follow-up Evaluation (SAFE)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Brief Adherence Rating Scale (BARS)
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.

Secondary Outcome Measures

Full Information

First Posted
October 14, 2019
Last Updated
September 20, 2023
Sponsor
VA Office of Research and Development
Collaborators
Providence VA Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04127604
Brief Title
Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use Disorders
Official Title
Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Providence VA Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Substance Use Disorders
Keywords
Bipolar Disorder, Substance Use Disorders, Treatment Adherence, Veterans, Psychosocial intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrated Treatment Adherence Program for Veterans (ITAP-VA)
Arm Type
Experimental
Arm Description
A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.
Arm Title
Safety Assessment and Follow-up Evaluation (SAFE)
Arm Type
Active Comparator
Arm Description
Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.
Intervention Type
Behavioral
Intervention Name(s)
Integrated Treatment Adherence Program for Veterans (ITAP-VA)
Intervention Description
Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.
Intervention Type
Behavioral
Intervention Name(s)
Safety Assessment and Follow-up Evaluation (SAFE)
Intervention Description
Measurement-based care assessment and evaluation.
Primary Outcome Measure Information:
Title
Brief Adherence Rating Scale (BARS)
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jane Metrik, PhD
Phone
(401) 273-7100
Ext
12024
Email
Jane.Metrik@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Brandon A Gaudiano, PhD
Phone
(401) 273-7100
Email
Brandon.Gaudiano@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Metrik, PhD
Organizational Affiliation
Providence VA Medical Center, Providence, RI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brandon A Gaudiano, PhD
Organizational Affiliation
Providence VA Medical Center, Providence, RI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence VA Medical Center, Providence, RI
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908-4734
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Marcolivio, MEd
Phone
401-273-7100
Ext
13464
Email
Kimberly.Marcolivio@va.gov
First Name & Middle Initial & Last Name & Degree
Brandon A Gaudiano, PhD
First Name & Middle Initial & Last Name & Degree
Jane Metrik, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs