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

Primary Purpose

Substance Abuse, Mental Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Double Trouble in Recovery
Treatment as usual
Sponsored by
Western Michigan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Proaction Health Alliance
  • Coney Island Hospital
  • BRC
  • South Beach Psychiatric Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Double Trouble (DTR) group

Treatment as usual

Arm Description

Double Trouble in Recovery groups

Treatment as usual while on a waiting list for DTR groups

Outcomes

Primary Outcome Measures

Substance abuse
Self-reported substance use and saliva toxicology for drugs

Secondary Outcome Measures

psychiatric medication adherence
Self-reported adherence to prescribed medications
Traditional 12-step meeting participation
Treatment retention
Quality of life

Full Information

First Posted
April 8, 2011
Last Updated
December 9, 2014
Sponsor
Western Michigan University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01333280
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Michigan University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. 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. To determine the personal, social/environmental and treatment-related variables which predict DTR affiliation. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Mental Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
352 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Double Trouble (DTR) group
Arm Type
Experimental
Arm Description
Double Trouble in Recovery groups
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Treatment as usual while on a waiting list for DTR groups
Intervention Type
Behavioral
Intervention Name(s)
Double Trouble in Recovery
Other Intervention Name(s)
12 Step groups
Intervention Description
DTR is a 12 Step-based fellowship for individuals with co-occurring problems of substance abuse and mental illness
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Receive usual treatment at the programs
Primary Outcome Measure Information:
Title
Substance abuse
Description
Self-reported substance use and saliva toxicology for drugs
Time Frame
Study intake and six month follow-up
Secondary Outcome Measure Information:
Title
psychiatric medication adherence
Description
Self-reported adherence to prescribed medications
Time Frame
six month follow-up
Title
Traditional 12-step meeting participation
Time Frame
six month follow-up
Title
Treatment retention
Time Frame
six month follow-up
Title
Quality of life
Time Frame
six month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Magura, Ph.D.
Organizational Affiliation
Western Michigan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Proaction Health Alliance
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49505
Country
United States
Facility Name
Coney Island Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
BRC
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
Facility Name
South Beach Psychiatric Center
City
New York
State/Province
New York
ZIP/Postal Code
10305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24342419
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.
Results Reference
result
PubMed Identifier
23515888
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.
Results Reference
result
PubMed Identifier
25309623
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.
Results Reference
result
PubMed Identifier
22873191
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.
Results Reference
result

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

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