Efficacy of Dual Focus Mutual Aid for Persons With Co-occurring Disorders

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Dual Focus Mutual Aid for Persons With Co-occurring Disorders

Conditions
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Substance Abuse, Mental Disorders

Intervention / Treatment
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* Behavioral: Double Trouble in Recovery
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double Trouble (DTR) group<br>Double Trouble in Recovery groups | Behavioral: Double Trouble in Recovery<br>* DTR is a 12 Step-based fellowship for individuals with co-occurring problems of substance abuse and mental illness<br>* Other names: 12 Step groups;|
| Active Comparator: Treatment as usual<br>Treatment as usual while on a waiting list for DTR groups | Behavioral: Treatment as usual<br>* Receive usual treatment at the programs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance abuse | Self-reported substance use and saliva toxicology for drugs | Study intake and six month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychiatric medication adherence | Self-reported adherence to prescribed medications | six month follow-up | 
| Traditional 12-step meeting participation |  | six month follow-up | 
| Treatment retention |  | six month follow-up | 
| Quality of life |  | six month follow-up |