Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04127604|
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : December 22, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04127604
|Contact: Jane Metrik, PhD||(401) 273-7100 ext 12024||Jane.Metrik@va.gov|
|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|
|Principal Investigator:||Jane Metrik, PhD||Providence VA Medical Center, Providence, RI|