Back to resultsIntervention for Comorbid Substance Use and Bipolar Disorders (ITAP)
Primary Purpose
Bipolar Disorder, Substance Use Disorders
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated Treatment Adherence Program (ITAP)
Safety Assessment and Follow-up Evaluation (SAFE)
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility Criteria
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
Sites / Locations
- Butler Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Integrated Treatment Adherence Program (ITAP)
Safety Assessment and Follow-up Evaluation (SAFE)
Arm Description
A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.
Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04202393
First Posted
December 16, 2019
Last Updated
October 2, 2023
Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04202393
Brief Title
Intervention for Comorbid Substance Use and Bipolar Disorders
Acronym
ITAP
Official Title
RCT to Improve Post-Hospital Treatment Adherence for Comorbid Substance Use and Bipolar Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Substance Use Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Integrated Treatment Adherence Program (ITAP)
Arm Type
Experimental
Arm Description
A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.
Arm Title
Safety Assessment and Follow-up Evaluation (SAFE)
Arm Type
Active Comparator
Arm Description
Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.
Intervention Type
Behavioral
Intervention Name(s)
Integrated Treatment Adherence Program (ITAP)
Intervention Description
Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.
Intervention Type
Behavioral
Intervention Name(s)
Safety Assessment and Follow-up Evaluation (SAFE)
Intervention Description
Enhanced assessment and evaluation with clinician feedback.
Primary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
Description
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.
Time Frame
6 months
Title
Clinician-Administered Rating Scale for Mania (CARS-M)
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon Gaudiano, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ivan Miller, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Upload to NIMH Data Archive
Learn more about this trial
Intervention for Comorbid Substance Use and Bipolar Disorders
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