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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Western Michigan University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephen Magura, Western Michigan University
ClinicalTrials.gov Identifier:
NCT01333280
First received: April 8, 2011
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Substance Abuse
Mental Disorders
Behavioral: Double Trouble in Recovery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Dual Focus Mutual Aid for Persons With Co-occurring Disorders

Resource links provided by NLM:


Further study details as provided by Western Michigan University:

Primary Outcome Measures:
  • Substance abuse [ Time Frame: Study intake and six month follow-up ] [ Designated as safety issue: No ]
    Self-reported substance use and saliva toxicology for drugs


Secondary Outcome Measures:
  • psychiatric medication adherence [ Time Frame: six month follow-up ] [ Designated as safety issue: No ]
    Self-reported adherence to prescribed medications

  • Traditional 12-step meeting participation [ Time Frame: six month follow-up ] [ Designated as safety issue: No ]
  • Treatment retention [ Time Frame: six month follow-up ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: six month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: July 2008
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Double Trouble (DTR) group 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
No Intervention: Treatment as usual
Subjects are randomly assigned to DTR or to a wait list for DTR (treatment as usual)
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333280

Contacts
Contact: Stephen Magura, Ph.D. 269-387-5895 stephen.magura@wmich.edu
Contact: Andrew Rosenblum, Ph.D. 212-845-4528 rosenblum@ndri.org

Locations
United States, Michigan
Proaction Health Alliance Recruiting
Grand Rapids, Michigan, United States, 49505
United States, New York
Coney Island Hospital Recruiting
Brooklyn, New York, United States, 11235
South Beach Psychiatric Center Recruiting
New York, New York, United States, 10305
Sub-Investigator: Thomas Uttaro, Ph.D.         
BRC Recruiting
New York, New York, United States, 10012
Sponsors and Collaborators
Western Michigan University
Investigators
Principal Investigator: Stephen Magura, Ph.D. Western Michigan University
  More Information

No publications provided

Responsible Party: Stephen Magura, Director, Evaluation Center, Western Michigan University
ClinicalTrials.gov Identifier: NCT01333280     History of Changes
Other Study ID Numbers: DUALFOCUSAID, 1R01DA023119-01A1
Study First Received: April 8, 2011
Last Updated: April 25, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Disease
Schizophrenia and Disorders with Psychotic Features
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014