Intervention for Comorbid Substance Use and Bipolar Disorders (ITAP)

Butler Hospital

Status: Completed

Conditions: Bipolar Disorder; Substance Use Disorders

Treatments: Behavioral: Safety Assessment and Follow-up Evaluation (SAFE); Behavioral: Integrated Treatment Adherence Program (ITAP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04202393

1370188-2

R01MH122870 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Diagnosis of a bipolar-spectrum disorder
• Diagnosis of a substance use disorder
• Taking at least one mood-stabilizing medication

Exclusion:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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178 participants in 2 patient groups

Integrated Treatment Adherence Program (ITAP)

Experimental group

Description:

A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.

Treatment:

Behavioral: Integrated Treatment Adherence Program (ITAP)

Safety Assessment and Follow-up Evaluation (SAFE)

Active Comparator group

Description:

Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.

Treatment:

Behavioral: Safety Assessment and Follow-up Evaluation (SAFE)