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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01333280
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : December 10, 2014
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Stephen Magura, Western Michigan University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Substance Abuse Mental Disorders Behavioral: Double Trouble in Recovery Behavioral: Treatment as usual Not Applicable

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:

  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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Substance abuse [ Time Frame: Study intake and six month follow-up ]
    Self-reported substance use and saliva toxicology for drugs

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • admission to one of the participating treatment programs
  • substance abuse/dependence
  • 18-65 years of age


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.

Information from the National Library of Medicine

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 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
Sponsors and Collaborators
Western Michigan University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Stephen Magura, Ph.D. Western Michigan University

Publications of Results:
Responsible Party: Stephen Magura, Director, Evaluation Center, Western Michigan University Identifier: NCT01333280     History of Changes
Other Study ID Numbers: DUALFOCUSAID
1R01DA023119-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders
Psychotic Disorders
Pathologic Processes
Chemically-Induced Disorders
Schizophrenia Spectrum and Other Psychotic Disorders