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Intervention for Comorbid Substance Use and Bipolar Disorders (ITAP)

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ClinicalTrials.gov Identifier: NCT04202393
Recruitment Status : Recruiting
First Posted : December 17, 2019
Last Update Posted : January 29, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Butler Hospital

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Substance Use Disorders Behavioral: Integrated Treatment Adherence Program (ITAP) Behavioral: Safety Assessment and Follow-up Evaluation (SAFE) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: RCT to Improve Post-Hospital Treatment Adherence for Comorbid Substance Use and Bipolar Disorders
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: Integrated Treatment Adherence Program (ITAP)
A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.
Behavioral: Integrated Treatment Adherence Program (ITAP)
Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.

Active Comparator: Safety Assessment and Follow-up Evaluation (SAFE)
Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.
Behavioral: Safety Assessment and Follow-up Evaluation (SAFE)
Enhanced assessment and evaluation with clinician feedback.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04202393


Contacts
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Contact: Gloria Peters 401-455-6476 GPeters@butler.org

Locations
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United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Cheryl Cordeiro    401-455-6654    ccordeiro@butler.org   
Principal Investigator: Brandon Gaudiano, PhD         
Principal Investigator: Ivan Miller, PhD         
Sponsors and Collaborators
Butler Hospital
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Brandon Gaudiano, PhD Butler Hospital
Principal Investigator: Ivan Miller, PhD Butler Hospital
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Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT04202393    
Other Study ID Numbers: 1370188-2
R01MH122870 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upload to NIMH Data Archive

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Chemically-Induced Disorders