Efficacy of Dual Focus Mutual Aid for Persons With Co-occurring Disorders
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Purpose
The purpose of the study is to determine whether adding "dual focus" mutual aid groups to formal treatment for people dually diagnosed with substance abuse and mental illness is effective in improving treatment outcomes.
NO VOLUNTEERS ARE ACCEPTED. ENROLLMENT IS LIMITED TO CLIENTS OF THE PARTICIPATING TREATMENT PROGRAMS.
| Condition | Intervention |
|---|---|
|
Substance Abuse Mental Disorders |
Behavioral: Double Trouble in Recovery |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy of Dual Focus Mutual Aid for Persons With Co-occurring Disorders |
- Substance abuse [ Time Frame: Study intake and six month follow-up ] [ Designated as safety issue: No ]Self-reported substance use and saliva toxicology for drugs
- psychiatric medication adherence [ Time Frame: six month follow-up ] [ Designated as safety issue: No ]Self-reported adherence to prescribed medications
- Traditional 12-step meeting participation [ Time Frame: six month follow-up ] [ Designated as safety issue: No ]
- Treatment retention [ Time Frame: six month follow-up ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: six month follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 320 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Double Trouble (DTR) group |
Behavioral: Double Trouble in Recovery
DTR is a 12 Step-based fellowship for individuals with co-occurring problems of substance abuse and mental illness
Other Name: 12 Step groups
|
|
No Intervention: Treatment as usual
Subjects are randomly assigned to DTR or to a wait list for DTR (treatment as usual)
|
Behavioral: Double Trouble in Recovery
DTR is a 12 Step-based fellowship for individuals with co-occurring problems of substance abuse and mental illness
Other Name: 12 Step groups
|
Detailed Description:
This study builds on two previous studies by the principal investigator, which found that participation in an established and growing "dual-focus" mutual aid model (Double Trouble in Recovery; DTR) by persons with co-occurring substance use and psychiatric disorders was associated with drug/alcohol abstinence and improved psychiatric outcomes. However, these findings are limited as they are based on studies using an observational design with existing DTR groups and a pre-post design with a historical control. This new application seeks to confirm and significantly extend this research by conducting a randomized clinical trial (RCT) of DTR at multiple treatment sites.
The specific study aims are:
- To conduct a multi-site RCT to determine the efficacy of "dual focus" 12-step mutual aid groups for persons with co-occurring substance use and mental disorders. Substance-using patients who are admitted to psychiatric outpatient clinics will be randomly assigned within each clinic to (i) DTR group participation plus standard treatment, or (ii) standard treatment as usual (wait list for DTR). The primary outcome is drug/alcohol use. The secondary outcomes are psychiatric medication adherence; quality of life; treatment retention; and traditional 12 step group participation. Major assessments will occur at baseline and 6 months later.
- To determine the therapeutic mechanisms mediating between DTR participation and behavioral outcomes. Hypothesized mediating variables will include both "common process" factors across treatments, e.g., coping, self-efficacy and social support; and factors relatively unique to mutual aid, e.g., mutual aid group processes, 12-step attitudes and spirituality.
- To determine the personal, social/environmental and treatment-related variables which predict DTR affiliation.
- To describe the development of DTR groups and the conditions needed to sustain them.
Federal substance abuse and mental health policy encourages the use of evidence-based interventions, yet rigorous evaluation data are scant for mutual aid groups. In particular, this research will lead to recommendations for improving the integration of formal treatment with mutual aid for persons with co-occurring disorders. Moreover, by conducting the proposed RCT, the study will substantially raise the standard by which mutual aid is evaluated.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- admission to one of the participating treatment programs
- substance abuse/dependence
- 18-65 years of age
NO VOLUNTEERS ARE ACCEPTED. ENROLLMENT IS LIMITED TO CLIENTS OF THE THE PARTICIPATING TREATMENT PROGRAMS.
Exclusion Criteria:
- Inability to conduct an interview in English or participate in English- language DTR groups
- Appears intoxicated on drugs or alcohol
- Carries a diagnosis of mental retardation
- Deemed actively psychotic by the clinic's intake coordinator
- Appears unable to understand and give informed consent.
Contacts and Locations| Contact: Stephen Magura, Ph.D. | 269-387-5895 | stephen.magura@wmich.edu |
| Contact: Andrew Rosenblum, Ph.D. | 212-845-4528 | rosenblum@ndri.org |
| United States, Michigan | |
| Proaction Health Alliance | Recruiting |
| Grand Rapids, Michigan, United States, 49505 | |
| United States, New York | |
| Coney Island Hospital | Recruiting |
| Brooklyn, New York, United States, 11235 | |
| South Beach Psychiatric Center | Recruiting |
| New York, New York, United States, 10305 | |
| Sub-Investigator: Thomas Uttaro, Ph.D. | |
| BRC | Recruiting |
| New York, New York, United States, 10012 | |
| Principal Investigator: | Stephen Magura, Ph.D. | Western Michigan University |
More Information
No publications provided
| Responsible Party: | Stephen Magura, Director, Evaluation Center, Western Michigan University |
| ClinicalTrials.gov Identifier: | NCT01333280 History of Changes |
| Other Study ID Numbers: | DUALFOCUSAID, 1R01DA023119-01A1 |
| Study First Received: | April 8, 2011 |
| Last Updated: | April 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Substance-Related Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on June 17, 2013