Treating Co-Occurring Substance Use and Mental Disorders Among Jail Inmates
Primary Purpose
Co-occurring Mental and Substance Use Disorders, Crime, Criminogenic Thinking
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dual-diagnosis motivational interviewing (DDMI)
Integrated group therapy (IGT)
Jail and community-based behavioral health services
Sponsored by
About this trial
This is an interventional treatment trial for Co-occurring Mental and Substance Use Disorders focused on measuring Jail, co-occurring disorders, implementation, acceptability, feasibility, fidelity
Eligibility Criteria
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:
-
Sites / Locations
- RTI International
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DDMI-IGT
Usual care
Arm Description
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).
Subjects randomized to the usual care condition will receive jail and community-based behavioral health services.
Outcomes
Primary Outcome Measures
Acceptability
Client Satisfaction Questionnaire-8, Narrative Evaluation of Intervention Interview
Secondary Outcome Measures
Feasibility of Adapted Interventions
How successfully can the adapted interventions be implemented (Focus Group interviews)
Fidelity
DDMI and IGT Adherence Forms
Substance use
Addiction Severity Index
Psychiatric symptoms
Brief Psychiatric Rating Scale
Health status
SF-12
Service use
Epidemiological Catchment Area Interview
Externalizing behaviors
Triarchic Psychopathy Measure
Quality of life measure
Heinrichs-Carpenter Quality of Life Scale, Plus
Arrest
Self-report and official jail records
Treatment preferences
Visual analog ranking of 8 different aspects of treatment
Full Information
NCT ID
NCT02214667
First Posted
August 10, 2014
Last Updated
March 13, 2020
Sponsor
RTI International
Collaborators
University of North Carolina, Chapel Hill, Boston University
1. Study Identification
Unique Protocol Identification Number
NCT02214667
Brief Title
Treating Co-Occurring Substance Use and Mental Disorders Among Jail Inmates
Official Title
Treating Co-Occurring Substance Use and Mental Disorders Among Jail Inmates
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Inability to recruit enough participants
Study Start Date
May 21, 2015 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RTI International
Collaborators
University of North Carolina, Chapel Hill, Boston University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Treatment adaptation and implementation study for adult jail inmates with co-occurring substance use disorders.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Co-occurring Mental and Substance Use Disorders, Crime, Criminogenic Thinking, Implementation, Adaptation
Keywords
Jail, co-occurring disorders, implementation, acceptability, feasibility, fidelity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DDMI-IGT
Arm Type
Experimental
Arm Description
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).
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Subjects randomized to the usual care condition will receive jail and community-based behavioral health services.
Intervention Type
Behavioral
Intervention Name(s)
Dual-diagnosis motivational interviewing (DDMI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Integrated group therapy (IGT)
Intervention Description
IGT is an evidence-based practice for treating co-occurring disorders. IGT focuses on relapse prevention by reducing substance use and stabilizing psychiatric symptoms.
Intervention Type
Behavioral
Intervention Name(s)
Jail and community-based behavioral health services
Intervention Description
Existing behavioral health service programs
Primary Outcome Measure Information:
Title
Acceptability
Description
Client Satisfaction Questionnaire-8, Narrative Evaluation of Intervention Interview
Time Frame
Study months 21 through 34
Secondary Outcome Measure Information:
Title
Feasibility of Adapted Interventions
Description
How successfully can the adapted interventions be implemented (Focus Group interviews)
Time Frame
Study months 21 through 34
Title
Fidelity
Description
DDMI and IGT Adherence Forms
Time Frame
Study months 21 through 34
Title
Substance use
Description
Addiction Severity Index
Time Frame
Study months 20 through 30
Title
Psychiatric symptoms
Description
Brief Psychiatric Rating Scale
Time Frame
Study months 20 through 30
Title
Health status
Description
SF-12
Time Frame
Study months 20 through 30
Title
Service use
Description
Epidemiological Catchment Area Interview
Time Frame
Study months 20 through 30
Title
Externalizing behaviors
Description
Triarchic Psychopathy Measure
Time Frame
Study months 20 through 30
Title
Quality of life measure
Description
Heinrichs-Carpenter Quality of Life Scale, Plus
Time Frame
Study months 20 through 30
Title
Arrest
Description
Self-report and official jail records
Time Frame
Study months 20 through 30
Title
Treatment preferences
Description
Visual analog ranking of 8 different aspects of treatment
Time Frame
Study months 20 through 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A Van Dorn, Ph.D.
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
RTI International
City
Research Triangle Park
State/Province
North Carolina
ZIP/Postal Code
27709
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
28778175
Citation
Van Dorn RA, Desmarais SL, Rade CB, Burris EN, Cuddeback GS, Johnson KL, Tueller SJ, Comfort ML, Mueser KT. Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial. Trials. 2017 Aug 4;18(1):365. doi: 10.1186/s13063-017-2088-z.
Results Reference
derived
Learn more about this trial
Treating Co-Occurring Substance Use and Mental Disorders Among Jail Inmates
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