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NCT04202393 Clinical Trial

Intervention for Comorbid Substance Use and Bipolar Disorders

Bipolar Disorder Clinical Trial

— ITAP  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04202393
Other study ID # 1370188-2
Secondary ID R01MH122870
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date August 31, 2024

Study information
Verified date October 2023
Source Butler Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 160
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Integrated Treatment Adherence Program (ITAP)
Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.
• Safety Assessment and Follow-up Evaluation (SAFE)
Enhanced assessment and evaluation with clinician feedback.

Locations
Country Name City State
United States Butler Hospital Providence Rhode Island

Sponsors (2)
Lead Sponsor Collaborator
Butler Hospital National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) 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. 6 months
Primary Clinician-Administered Rating Scale for Mania (CARS-M) 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. 6 months
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