Viewing Study NCT04127604


Ignite Creation Date: 2025-12-24 @ 7:50 PM
Ignite Modification Date: 2025-12-29 @ 10:35 PM
Study NCT ID: NCT04127604
Status: COMPLETED
Last Update Posted: 2025-10-22
First Post: 2019-10-14
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use Disorders
Sponsor: VA Office of Research and Development
Organization:

Study Overview

Official Title: Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use Disorders
Status: COMPLETED
Status Verified Date: 2025-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
IRB-2019-027 OTHER Providence VA Medical Center View