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

Study Overview
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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.

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

Conditions
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Bipolar Disorder, Substance Use Disorders

Intervention / Treatment
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* Behavioral: Integrated Treatment Adherence Program for Veterans (ITAP-VA)
* Behavioral: Safety Assessment and Follow-up Evaluation (SAFE)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Disorder, Substance Use Disorders, Treatment Adherence, Veterans, Psychosocial intervention