12-step Facilitation for the Dually Diagnosed

Completed · Phase 1/Phase 2

Conditions studied: Alcoholism, Diagnosis, Dual (Psychiatry)

In brief

This is a randomized trial testing the efficacy of a modified 12-step facilitation therapy for individuals with serious mental illness and alcohol use disorders, compared to usual treatment. 135 participants are randomized in 2:1 ratio to the modified 12-step facilitation (12 sessions of individual counseling) vs. treatment as usual. The primary hypothesis is that those receiving 12-step facilitation will have better drinking outcomes (percent days abstinence and drinks per drinking day)at end of treatment.

Key facts

Study ID

NCT00583440

Run by

University of New Mexico

People needed

121

Starts

2005-09-01

Expected to finish

2011-05-01

Last updated by the study team

2013-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• SCID Diagnosis of a psychotic disorder (schizophrenia, schizoaffective disorder, or psychosis not otherwise specified) or a major affective disorder (major depression, bipolar disorder, or depressive disorder not otherwise specified, provided in the latter case that criteria have been met for a major depressive episode).
• SCID diagnosis of alcohol abuse or dependence which is active within the past 1 month (i.e., not in early or sustained full remission).
• Two or more days of heavy drinking (5 or more drinks for per occasion for a man, 4 or more drinks per occasion for a woman) in the 30 days prior to screening.
• Willingness to participate in specialized 12-step programs.
• Ability to provide informed consent.
• Ability to read, speak, and understand English at least the 5th grade level.
• Ability to provide at least one contact person to assist in tracking for follow-up assessment.

You may not qualify if…

• Current attendance of any 12-step program (two or more 12-step meetings in the past month).
• Unstable psychiatric illness, defined by psychiatric hospitalization in the past 1 month; more than 3 hospitalizations in the past year; or psychosis or mania which would render the individual incapable of informed consent.
• Active suicidality (any clinically significant suicide attempts in the past 3 months or any current suicidal intent or definite plan).
• Current homicidal ideation aimed at a specific person or persons.
• Medical illness which is severe enough to compromise participation in the study.
• Mental retardation, dementia, or other cognitive impairment of sufficient severely to render the individual incapable of informed consent or incapable of comprehending and participating in the TSF therapy or 12-step meetings.
• Expectation of being out of town or in jail for more than 21 days during the treatment period.
• Expectation of participation in any other formal addiction treatment during the study period (not including TAU, 12-step or other mutual support groups).
• Current engagement in behavioral health treatment (including case management) at another facility.
• Current engagement in non-TAU treatment at UNMPC, such as psychotherapy, intensive outpatient treatment, or MET.

Where it is running

• UNM HSC Department of Psychiatry Clinical Trials — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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