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

NCT ID: NCT01333280

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2014-04-30

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:

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.

Conditions

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Substance Abuse Mental Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Double Trouble (DTR) group

Double Trouble in Recovery groups

Group Type EXPERIMENTAL

Double Trouble in Recovery

Intervention Type BEHAVIORAL

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

Treatment as usual

Treatment as usual while on a waiting list for DTR groups

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

Receive usual treatment at the programs

Interventions

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Double Trouble in Recovery

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

Intervention Type BEHAVIORAL

Treatment as usual

Receive usual treatment at the programs

Intervention Type BEHAVIORAL

Other Intervention Names

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12 Step groups

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Western Michigan University

OTHER

Sponsor Role lead

Responsible Party

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Stephen Magura

Director, Evaluation Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen Magura, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Western Michigan University

Locations

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Proaction Health Alliance

Grand Rapids, Michigan, United States

Site Status

Coney Island Hospital

Brooklyn, New York, United States

Site Status

BRC

New York, New York, United States

Site Status

South Beach Psychiatric Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 24342419 (View on PubMed)

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.

Reference Type RESULT
PMID: 23515888 (View on PubMed)

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.

Reference Type RESULT
PMID: 25309623 (View on PubMed)

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.

Reference Type RESULT
PMID: 22873191 (View on PubMed)

Other Identifiers

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1R01DA023119-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DUALFOCUSAID

Identifier Type: -

Identifier Source: org_study_id