12-step Facilitation for the Dually Diagnosed

NCT00583440 | Completed Phase 1

• 3 other identifiers: NIAAA-Bogenschutz-AA015419R01AA015419NIH Grant 1R01 AA015419
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcoholism; Diagnosis, Dual (Psychiatry)

Keywords

12-step; mutual help; dual diagnosis; serious mental illness

Outcome Measures

Primary Outcomes (1)

• Percent days abstinent from alcohol

  12, 24, 36, and 48 weeks

Secondary Outcomes (2)

• Drinks per drinking day

  12, 24, 36, and 48 weeks

• 12-step participation

  12, 24, 36, and 48 weeks

Study Arms (2)

1

EXPERIMENTAL

Behavioral: 12-step facilitation

2

ACTIVE COMPARATOR

Behavioral: Treatment as usual

Interventions

12-step facilitation BEHAVIORAL

12 weekly individual 12-step facilitation sessions

1

Treatment as usual BEHAVIORAL

Usual clinical treatment in a dual diagnosis treatment program

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of New Mexico: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

UNM HSC Department of Psychiatry Clinical Trials

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

• Houck JM, Forcehimes AA, Gutierrez ET, Bogenschutz MP. Test-retest reliability of self-report measures in a dually diagnosed sample. Subst Use Misuse. 2013 Jan;48(1-2):99-105. doi: 10.3109/10826084.2012.731674. Epub 2012 Oct 25.

  PMID: 23098171 DERIVED

MeSH Terms

Conditions

Alcoholism; Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael P. Bogenschutz, MD

  University of New Mexico Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: September 1, 2005
• Primary Completion: September 1, 2010
• Study Completion: May 1, 2011
• Last Updated: January 30, 2013

Record last verified: 2013-01

Locations

US (1)