Co-occurring Mental and Substance Use DisordersNCT02214667
Treating Co-Occurring Substance Use and Mental Disorders Among Jail Inmates
A study testing Dual-diagnosis motivational interviewing (DDMI), Integrated group therapy (IGT) and Jail and community-based behavioral health services in people with Co-occurring Mental and Substance Use Disorders and Crime, run by RTI International at 1 site in United States.
Trial summary
Treatment adaptation and implementation study for adult jail inmates with co-occurring substance use disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Co-occurring Mental and Substance Use Disorders, Crime, Criminogenic Thinking
- What is being tested?
- Dual-diagnosis motivational interviewing (DDMI), Integrated group therapy (IGT) and Jail and community-based behavioral health services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2015to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
RTI International
Research Triangle Park, North Carolina, 27709
About this study
Treatment adaptation and implementation study for adult jail inmates with co-occurring substance use disorders.
Read the 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.
- Conditions
- Co-occurring Mental and Substance Use Disorders, Crime, Criminogenic Thinking, Implementation, Adaptation
- Being tested
- Dual-diagnosis motivational interviewing (DDMI), Integrated group therapy (IGT), Jail and community-based behavioral health services
- Keywords
- Jail, co-occurring disorders, implementation, acceptability, feasibility, fidelity
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-diagnosis motivational interviewing (DDMI)Behavioural
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.
Integrated group therapy (IGT)Behavioural
IGT is an evidence-based practice for treating co-occurring disorders. IGT focuses on relapse prevention by reducing substance use and stabilizing psychiatric symptoms.
Jail and community-based behavioral health servicesBehavioural
Existing behavioral health service programs
| Study group | Role | What they receive |
|---|---|---|
| DDMI-IGT | Experimental | 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). Receives: Behavioral: Dual-diagnosis motivational interviewing (DDMI); Behavioral: Integrated group therapy (IGT) |
| Usual care | Active comparator | Subjects randomized to the usual care condition will receive jail and community-based behavioral health services. Receives: Behavioral: Jail and community-based behavioral health services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Client Satisfaction Questionnaire-8, Narrative Evaluation of Intervention Interview
Measured: Study months 21 through 34
Secondary outcomes (10)
Feasibility of Adapted Interventions
How successfully can the adapted interventions be implemented (Focus Group interviews)
Measured: Study months 21 through 34
Fidelity
DDMI and IGT Adherence Forms
Measured: Study months 21 through 34
Substance use
Addiction Severity Index
Measured: Study months 20 through 30
Psychiatric symptoms
Brief Psychiatric Rating Scale
Measured: Study months 20 through 30
Health status
SF-12
Measured: Study months 20 through 30
Service use
Epidemiological Catchment Area Interview
Measured: Study months 20 through 30
Externalizing behaviors
Triarchic Psychopathy Measure
Measured: Study months 20 through 30
Quality of life measure
Heinrichs-Carpenter Quality of Life Scale, Plus
Measured: Study months 20 through 30
Arrest
Self-report and official jail records
Measured: Study months 20 through 30
Treatment preferences
Visual analog ranking of 8 different aspects of treatment
Measured: Study months 20 through 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study start21 May 2015
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Why it stopped: Inability to recruit enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Co-occurring Mental and Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Boston University
- Responsible party
- Sponsor
- Investigators
- Richard A Van Dorn, Ph.D., Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214667
- Sponsor's protocol ID
- R34DA036791
- Status last verified
- Mar 2020
- First submitted
- 10 Aug 2014
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 28778175
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Co-Occurring Substance Use and Mental Disorders Among Jail Inmates
- ClinicalTrials.gov ID
- NCT02214667
- Acronym / sponsor ID
- R34DA036791
- Conditions
- Co-occurring Mental and Substance Use Disorders, Crime, Criminogenic Thinking, Implementation, Adaptation
- Keywords
- Jail, co-occurring disorders, implementation, acceptability, feasibility, fidelity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit enough participants
- Enrolment
- 8 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Boston University
- Study start
- 21 May 2015 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DDMI-IGT | Experimental | Behavioral: Dual-diagnosis motivational interviewing (DDMI), Behavioral: Integrated group therapy (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). |
| Usual care | Active comparator | Behavioral: Jail and community-based behavioral health servicesSubjects randomized to the usual care condition will receive jail and community-based behavioral health services. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-diagnosis motivational interviewing (DDMI)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. | Behavioural | DDMI-IGT |
| Integrated group therapy (IGT)IGT is an evidence-based practice for treating co-occurring disorders. IGT focuses on relapse prevention by reducing substance use and stabilizing psychiatric symptoms. | Behavioural | DDMI-IGT |
| Jail and community-based behavioral health servicesExisting behavioral health service programs | Behavioural | Usual care |
Primary outcome
Acceptability
Time frame: Study months 21 through 34
Client Satisfaction Questionnaire-8, Narrative Evaluation of Intervention Interview
10 secondary outcomes
Feasibility of Adapted Interventions
Time frame: Study months 21 through 34
Fidelity
Time frame: Study months 21 through 34
Substance use
Time frame: Study months 20 through 30
Psychiatric symptoms
Time frame: Study months 20 through 30
Health status
Time frame: Study months 20 through 30
Service use
Time frame: Study months 20 through 30
Externalizing behaviors
Time frame: Study months 20 through 30
Quality of life measure
Time frame: Study months 20 through 30
Arrest
Time frame: Study months 20 through 30
Treatment preferences
Time frame: Study months 20 through 30
Results and safety
The study was stopped early (reason given: Inability to recruit enough participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Derived from this study: PubMed 28778175Van 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard A Van Dorn, Ph.D. principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-diagnosis motivational interviewing (DDMI), Integrated group therapy (IGT) and Jail and community-based behavioral health services in people with Co-occurring Mental and Substance Use Disorders and Crime, run by RTI International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inability to recruit enough participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: Study months 21 through 34). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02214667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.