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Trial record 2 of 47 for:    Not yet recruiting Studies | substance use

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 : Not yet recruiting
First Posted : October 15, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Jane Metrik, Providence VA Medical Center

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.

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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
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion:

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

Exclusion:

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

Information from the National Library of Medicine

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


Contacts
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Contact: Jane Metrik, PhD 401-273-7100 jane.metrik@va.gov

Locations
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United States, Rhode Island
Providence VA Medical Center
Providence, Rhode Island, United States, 02908
Contact: Kimberly Marcolivio, M.Ed.    401-273-7100 ext 3464    kimberly.marcolivio@va.gov   
Sponsors and Collaborators
Providence VA Medical Center
Investigators
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Principal Investigator: Jane Metrik, PhD Providence VA Medical Center
Principal Investigator: Brandon Gaudiano, PhD Providence VA Medical Center

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Responsible Party: Jane Metrik, Principal Investigator, Providence VA Medical Center
ClinicalTrials.gov Identifier: NCT04127604    
Other Study ID Numbers: IRB-2019-027
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jane Metrik, Providence VA Medical Center:
Bipolar Disorder
Substance Use Disorders
Treatment Adherence
Veterans
Psychosocial intervention
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Chemically-Induced Disorders