Intervention for Comorbid Substance Use and Bipolar Disorders

Not Applicable

• Conditions: Bipolar Disorder; Substance Use Disorders
• Interventions: Behavioral: Integrated Treatment Adherence Program (ITAP); Behavioral: Safety Assessment and Follow-up Evaluation (SAFE)

• Registration Number: NCT04202393
• Lead Sponsor: Butler Hospital

Brief Summary

This trial aims to evaluate the effectiveness of a novel intervention for patients 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

Not available

Study Timeline

• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-17
• Study Start: 2020-10-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated Treatment Adherence Program (ITAP)	Integrated Treatment Adherence Program (ITAP)	A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.
Safety Assessment and Follow-up Evaluation (SAFE)	Safety Assessment and Follow-up Evaluation (SAFE)	Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.

Primary Outcome Measures

Name	Time	Method
Clinician-Administered Rating Scale for Mania (CARS-M)	6 months	The Clinician-Administered Rating Scale for Mania (CARS-M) assesses mania symptom severity. Total scores range from 0 to 50 and higher scores indicated higher symptom severity.
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)	6 months	The Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) assesses depressive symptom severity. Total scores range from 0 to 27 and higher scores indicated higher symptom severity.

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States