Intervention for Comorbid Substance Use and Bipolar Disorders

NCT ID: NCT04202393

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-21

Study Completion Date

2025-08-31

Brief Summary

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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

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Conditions

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Bipolar Disorder Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Integrated Treatment Adherence Program (ITAP)

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

Group Type EXPERIMENTAL

Integrated Treatment Adherence Program (ITAP)

Intervention Type BEHAVIORAL

Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.

Safety Assessment and Follow-up Evaluation (SAFE)

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

Group Type ACTIVE_COMPARATOR

Safety Assessment and Follow-up Evaluation (SAFE)

Intervention Type BEHAVIORAL

Enhanced assessment and evaluation with clinician feedback.

Interventions

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Integrated Treatment Adherence Program (ITAP)

Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.

Intervention Type BEHAVIORAL

Safety Assessment and Follow-up Evaluation (SAFE)

Enhanced assessment and evaluation with clinician feedback.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brandon Gaudiano, PhD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Ivan Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Locations

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Butler Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH122870

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1370188-2

Identifier Type: -

Identifier Source: org_study_id

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