Clinical trial NCT01333280: Efficacy of Dual Focus Mutual Aid for Persons With Co-occurring Disorders
Official title: Efficacy of Dual Focus Mutual Aid for Persons With Co-occurring Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Mental Disorders
Lead sponsor: Western Michigan University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-04-11
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Substance abuse
timeFrame: Study intake and six month follow-up
Secondary outcomes:
measure: psychiatric medication adherence
timeFrame: six month follow-up
measure: Traditional 12-step meeting participation
timeFrame: six month follow-up
measure: Treatment retention
timeFrame: six month follow-up
measure: Quality of life
timeFrame: six month follow-up
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Proaction Health Alliance
state: Michigan
city: Brooklyn
country: United States
facility: Coney Island Hospital
state: New York
city: New York
country: United States
facility: BRC
state: New York
city: New York
country: United States
facility: South Beach Psychiatric Center
state: New York
Study officials:
affiliation: Western Michigan University
name: Stephen Magura, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.