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CompletedNCT01333280Updated Dec 10, 2014

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

An interventional study of Double Trouble in Recovery and Treatment as usual in Substance Abuse and Mental Disorders, sponsored by Western Michigan University. Completed at 4 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-12-10.

Sponsored by Western Michigan University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
352
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

NO VOLUNTEERS ARE ACCEPTED. ENROLLMENT IS LIMITED TO CLIENTS OF THE PARTICIPATING TREATMENT PROGRAMS.

Read the 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.

02

Conditions studied

  • Substance Abuse
  • Mental Disorders
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 352 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Western Michigan University is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
352 participants (actual)

Study arms

  • Experimental
    Double Trouble (DTR) group

    Double Trouble in Recovery groups

    Behavioral: Double Trouble in Recovery

  • Active comparator
    Treatment as usual

    Treatment as usual while on a waiting list for DTR groups

    Behavioral: Treatment as usual

Interventions

  • BehavioralDouble Trouble in Recovery

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

    Also known as: 12 Step groups

  • BehavioralTreatment as usual

    Receive usual treatment at the programs

06

What researchers measure

Primary outcomes

  1. Substance abuse

    Self-reported substance use and saliva toxicology for drugs

    Time frame: Study intake and six month follow-up

Secondary outcomes

  1. psychiatric medication adherence

    Self-reported adherence to prescribed medications

    Time frame: six month follow-up

  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

07

Study locations

4 sites
  • Proaction Health Alliance
    Grand Rapids, Michigan 49505, United States
  • Coney Island Hospital
    Brooklyn, New York 11235, United States
  • BRC
    New York, New York 10012, United States
  • South Beach Psychiatric Center
    New York, New York 10305, United States
08

References and documents

Publications

  • Rosenblum A, Matusow H, Fong C, Vogel H, Uttaro T, Moore TL, Magura S. Efficacy of dual focus mutual aid for persons with mental illness and substance misuse. Drug Alcohol Depend. 2014 Feb 1;135:78-87. doi: 10.1016/j.drugalcdep.2013.11.012. Epub 2013 Nov 18. PubMed 24342419 ↗
  • Matusow H, Guarino H, Rosenblum A, Vogel H, Uttaro T, Khabir S, Rini M, Moore T, Magura S. Consumers' Experiences in Dual Focus Mutual Aid for Co-occurring Substance Use and Mental Health Disorders. Subst Abuse. 2013;7:39-47. doi: 10.4137/SART.S11006. Epub 2013 Mar 6. PubMed 23515888 ↗
  • Magura S, Mateu PF, Rosenblum A, Matusow H, Fong C. Risk factors for medication non-adherence among psychiatric patients with substance misuse histories. Ment Health Subst Use. 2014 Nov;7(4):381-390. doi: 10.1080/17523281.2013.839574. PubMed 25309623 ↗
  • Matusow H, Rosenblum A, Fong C, Laudet A, Uttaro T, Magura S. Factors associated with mental health clinicians' referrals to 12-Step groups. J Addict Dis. 2012;31(3):303-12. doi: 10.1080/10550887.2012.694605. PubMed 22873191 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01333280
Lead sponsor
Western Michigan University
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Stephen Magura (Director, Evaluation Center, Western Michigan University) — Principal investigator
First posted
Apr 11, 2011
Start date
Jul 2008
Primary completion
Nov 2012
Completion
Apr 2014
Last update
Dec 10, 2014

Study contacts

Stephen Magura, Ph.D.
principal investigator · Western Michigan University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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