Substance Abuse Clinical Trial
Official title:
Efficacy of Dual Focus Mutual Aid for Persons With Co-occurring Disorders
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.
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:
1. 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.
2. 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.
3. To determine the personal, social/environmental and treatment-related variables which
predict DTR affiliation.
4. 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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