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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01333280
Enrollment
352
Registered
2011-04-11
Start date
2008-07-31
Completion date
2014-04-30
Last updated
2014-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorders, Substance Abuse

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.

Interventions

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

BEHAVIORALTreatment as usual

Receive usual treatment at the programs

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Western Michigan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Substance abuseStudy intake and six month follow-upSelf-reported substance use and saliva toxicology for drugs

Secondary

MeasureTime frameDescription
psychiatric medication adherencesix month follow-upSelf-reported adherence to prescribed medications
Traditional 12-step meeting participationsix month follow-up
Treatment retentionsix month follow-up
Quality of lifesix month follow-up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026