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Intervention for Comorbid Substance Use and Bipolar Disorders

NCT04202393 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Integrated Treatment Adherence Program (ITAP)

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

BEHAVIORAL

Safety Assessment and Follow-up Evaluation (SAFE)

Enhanced assessment and evaluation with clinician feedback.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Butler Hospital

    lead OTHER

Principal Investigators

  • Brandon Gaudiano, PhD · Butler Hospital

  • Ivan Miller, PhD · Butler Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-21
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04202393 on ClinicalTrials.gov