Efficacy of Dual Focus Mutual Aid for Persons With Co-occurring Disorders
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|ClinicalTrials.gov Identifier: NCT01333280|
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : December 10, 2014
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 or disease||Intervention/treatment||Phase|
|Substance Abuse Mental Disorders||Behavioral: Double Trouble in Recovery Behavioral: Treatment as usual||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||352 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Dual Focus Mutual Aid for Persons With Co-occurring Disorders|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||April 2014|
Experimental: Double Trouble (DTR) group
Double Trouble in Recovery groups
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
Active Comparator: Treatment as usual
Treatment as usual while on a waiting list for DTR groups
Behavioral: Treatment as usual
Receive usual treatment at the programs
- Substance abuse [ Time Frame: Study intake and six month follow-up ]Self-reported substance use and saliva toxicology for drugs
- psychiatric medication adherence [ Time Frame: six month follow-up ]Self-reported adherence to prescribed medications
- Traditional 12-step meeting participation [ Time Frame: six month follow-up ]
- Treatment retention [ Time Frame: six month follow-up ]
- Quality of life [ Time Frame: six month follow-up ]
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): NCT01333280
|United States, Michigan|
|Proaction Health Alliance|
|Grand Rapids, Michigan, United States, 49505|
|United States, New York|
|Coney Island Hospital|
|Brooklyn, New York, United States, 11235|
|New York, New York, United States, 10012|
|South Beach Psychiatric Center|
|New York, New York, United States, 10305|
|Principal Investigator:||Stephen Magura, Ph.D.||Western Michigan University|