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Completed

NCT Number: NCT04202393

Intervention for Comorbid Substance Use and Bipolar Disorders

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Chemically-Induced Disorders Mental Disorders Mood Disorders Substance Use Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated Treatment Adherence Program (ITAP)

Behavioral

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

Safety Assessment and Follow-up Evaluation (SAFE)

Behavioral

Enhanced assessment and evaluation with clinician feedback.

Primary outcomes

  1. Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)

    Time frame: 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.

  2. Clinician-Administered Rating Scale for Mania (CARS-M)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

RCT to Improve Post-Hospital Treatment Adherence for Comorbid Substance Use and Bipolar Disorders

Acronym: ITAP

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2019
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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