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Completed

NCT Number: NCT01333280

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Proaction Health Alliance, Grand Rapids, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Double Trouble in Recovery

Behavioral

DTR is a 12 Step-based fellowship for individuals with co-occurring problems of substance abuse and mental illness

Other names: 12 Step groups

Treatment as Usual

Behavioral

Receive usual treatment at the programs

Primary outcomes

  1. Substance abuse

    Time frame: Study intake and six month follow-up

    Self-reported substance use and saliva toxicology for drugs

Secondary outcomes

  1. psychiatric medication adherence

    Time frame: six month follow-up

    Self-reported adherence to prescribed medications

  2. Traditional 12-step meeting participation

    Time frame: six month follow-up

  3. Treatment retention

    Time frame: six month follow-up

  4. Quality of life

    Time frame: six month follow-up

Sponsors and collaborators

Lead sponsor

Western Michigan University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2014
First posted
Apr 11, 2011
Registry last updated
Dec 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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