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

Substance Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333280
• Other study ID #: DUALFOCUSAID
• Secondary ID: 1R01DA023119-01A
• Status: Completed
• Phase: N/A
• First received: April 8, 2011
• Last updated: December 9, 2014
• Start date: July 2008
• Est. completion date: April 2014

Study information

• Verified date: December 2014
• Source: Western Michigan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: April 2014
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Substance Abuse

Intervention

Behavioral:
• Double Trouble in Recovery
DTR is a 12 Step-based fellowship for individuals with co-occurring problems of substance abuse and mental illness
• Treatment as usual
Receive usual treatment at the programs

Locations

Country	Name	City	State
United States	Coney Island Hospital	Brooklyn	New York
United States	Proaction Health Alliance	Grand Rapids	Michigan
United States	BRC	New York	New York
United States	South Beach Psychiatric Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Western Michigan University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. Epu — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance abuse	Self-reported substance use and saliva toxicology for drugs	Study intake and six month follow-up	No
Secondary	psychiatric medication adherence	Self-reported adherence to prescribed medications	six month follow-up	No
Secondary	Traditional 12-step meeting participation		six month follow-up	No
Secondary	Treatment retention		six month follow-up	No
Secondary	Quality of life		six month follow-up	No