Intervention for Comorbid Substance Use and Bipolar Disorders
ITAP
RCT to Improve Post-Hospital Treatment Adherence for Comorbid Substance Use and Bipolar Disorders
2 other identifiers
interventional
178
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2019
CompletedFirst Posted
Study publicly available on registry
December 17, 2019
CompletedStudy Start
First participant enrolled
October 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedNovember 18, 2025
November 1, 2025
4.9 years
December 16, 2019
November 17, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
Integrated Treatment Adherence Program (ITAP)
EXPERIMENTALA combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.
Safety Assessment and Follow-up Evaluation (SAFE)
ACTIVE COMPARATOREnhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.
Interventions
Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.
Enhanced assessment and evaluation with clinician feedback.
Eligibility Criteria
You may qualify if:
- Diagnosis of a bipolar-spectrum disorder
- Diagnosis of a substance use disorder
- Taking at least one mood-stabilizing medication
You may not qualify if:
- Unable to speak and read English
- Younger than age 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Butler Hospitallead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Butler Hospital
Providence, Rhode Island, 02906, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brandon Gaudiano, PhD
Butler Hospital
- PRINCIPAL INVESTIGATOR
Ivan Miller, PhD
Butler Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2019
First Posted
December 17, 2019
Study Start
October 21, 2020
Primary Completion
August 31, 2025
Study Completion
August 31, 2025
Last Updated
November 18, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
Upload to NIMH Data Archive