- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02214667
Treating Co-Occurring Substance Use and Mental Disorders Among Jail Inmates
March 13, 2020 updated by: RTI International
Treatment adaptation and implementation study for adult jail inmates with co-occurring substance use disorders.
Study Overview
Status
Terminated
Conditions
Detailed Description
We will adapt dual-diagnosis motivational interviewing and integrated group therapy for jail inmates with co-occurring substance use and mental health disorders and to evaluate the feasibility of implementing the adapted interventions and associated research and communication protocols.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Research Triangle Park, North Carolina, United States, 27709
- RTI International
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- (1) drug or alcohol abuse or dependence and SMI (major depressive disorder; depressive disorder not otherwise specified [NOS]; bipolar disorder I, II, or NOS; schizophrenia spectrum disorder; schizoaffective disorder; schizophreniform disorder; brief psychotic disorder; delusional disorder; or psychotic disorder NOS);
- (2) resident of Wake County and detained in The Jail;
- (3) >18 years of age; (4) able to speak/read English; and (5) able to provide informed consent.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DDMI-IGT
Subjects randomized to the experimental condition will receive adapted versions of dual-diagnosis motivational interviewing ([DDMI] one session before release from jail) and integrated group therapy ([IGT] 12 community-based sessions over a 2-month period).
|
DDMI is an evidence-based adaptation to motivational interviewing.
DDMI incorporates an integrated framework and accommodates cognitive impairments and disordered thinking associated with co-occurring substance use and mental disorders.
IGT is an evidence-based practice for treating co-occurring disorders.
IGT focuses on relapse prevention by reducing substance use and stabilizing psychiatric symptoms.
|
|
Active Comparator: Usual care
Subjects randomized to the usual care condition will receive jail and community-based behavioral health services.
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Existing behavioral health service programs
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability
Time Frame: Study months 21 through 34
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Client Satisfaction Questionnaire-8, Narrative Evaluation of Intervention Interview
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Study months 21 through 34
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Adapted Interventions
Time Frame: Study months 21 through 34
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How successfully can the adapted interventions be implemented (Focus Group interviews)
|
Study months 21 through 34
|
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Fidelity
Time Frame: Study months 21 through 34
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DDMI and IGT Adherence Forms
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Study months 21 through 34
|
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Substance use
Time Frame: Study months 20 through 30
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Addiction Severity Index
|
Study months 20 through 30
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Psychiatric symptoms
Time Frame: Study months 20 through 30
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Brief Psychiatric Rating Scale
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Study months 20 through 30
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Health status
Time Frame: Study months 20 through 30
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SF-12
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Study months 20 through 30
|
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Service use
Time Frame: Study months 20 through 30
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Epidemiological Catchment Area Interview
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Study months 20 through 30
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Externalizing behaviors
Time Frame: Study months 20 through 30
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Triarchic Psychopathy Measure
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Study months 20 through 30
|
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Quality of life measure
Time Frame: Study months 20 through 30
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Heinrichs-Carpenter Quality of Life Scale, Plus
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Study months 20 through 30
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Arrest
Time Frame: Study months 20 through 30
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Self-report and official jail records
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Study months 20 through 30
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Treatment preferences
Time Frame: Study months 20 through 30
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Visual analog ranking of 8 different aspects of treatment
|
Study months 20 through 30
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard A Van Dorn, Ph.D., RTI International
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 21, 2015
Primary Completion (Actual)
June 30, 2019
Study Completion (Actual)
June 30, 2019
Study Registration Dates
First Submitted
August 10, 2014
First Submitted That Met QC Criteria
August 10, 2014
First Posted (Estimate)
August 12, 2014
Study Record Updates
Last Update Posted (Actual)
March 17, 2020
Last Update Submitted That Met QC Criteria
March 13, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34DA036791 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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