12-step Facilitation for the Dually Diagnosed

NCT ID: NCT00583440

Last Updated: 2013-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2011-05-31

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.

Detailed Description

Although there has been relatively little work on 12-step treatment for seriously mentally ill patients, extant literature indicates that dually diagnosed individuals attend traditional 12-step programs such as AA, NA, and CA at rates comparable to singly diagnosed substance abusers, and that participation is associated with decreases in substance use. Specialized 12-step programs for the dually diagnosed, developed over the past 10 years, may offer additional benefits. In order to maximize the effectiveness of specialized and traditional 12-step programs for dually diagnosed individuals, specially adapted 12-step facilitation (TSF) treatment for the dually diagnosed should be developed and tested. Standard TSF should be modified to address the special needs of dually diagnosed individuals, mesh with specialized 12-step programs available in the area, and address barriers to attendance, participation, and engagement experienced by the dually diagnosed. We have developed a modified TSF based on the Project MATCH TSF manual. Modifications to this 12 week individual therapy include: emphasis on specialized 12-step program attendance; readings primarily from specialized 12-step program literature; participation in the second session by a community specialized 12-step program member; case management to assist participants in finding and attending meetings; omission of work on the fourth step; and the addition of topics covering medication compliance and specific social skills needed to negotiate 12-step meetings. In a pilot study with 10 dually diagnosed individuals, participants showed significant decreases in substance use and significant increases in 12-step attendance after receiving the specialized TSF. Building on this pilot study, the proposed study is a larger Stage 1b study of the modified TSF for seriously mentally ill patients engaged in dual diagnosis treatment. Participants with a psychotic or major affective disorder will be randomized to modified TSF (n=90) vs. treatment as usual (n=45). Participants will be followed for a total of 48 weeks. Assessments will include rigorous diagnosis and measures of alcohol and other drug use, consequences, psychiatric symptoms, 12-step behaviors, 12-step specific and non-specific change mechanisms, and social support. Specific Aims of the study include assessment of the integrity of the planned intervention and assessment battery; tests of the effectiveness of the adapted TSF relative to treatment as usual; determination of whether psychiatric diagnosis moderates treatment response; and investigation of causal mechanisms of response to treatment.

Conditions

Alcoholism; Diagnosis, Dual (Psychiatry)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

12-step facilitation

Intervention Type: BEHAVIORAL

12 weekly individual 12-step facilitation sessions

2

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

Usual clinical treatment in a dual diagnosis treatment program

Interventions

12-step facilitation

12 weekly individual 12-step facilitation sessions

Intervention Type: BEHAVIORAL

Treatment as usual

Usual clinical treatment in a dual diagnosis treatment program

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 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).

2. SCID diagnosis of alcohol abuse or dependence which is active within the past 1 month (i.e., not in early or sustained full remission).

3. 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.

4. Willingness to participate in specialized 12-step programs.

5. Ability to provide informed consent.

6. Ability to read, speak, and understand English at least the 5th grade level.

7. Ability to provide at least one contact person to assist in tracking for follow-up assessment.

Exclusion Criteria

1. Current attendance of any 12-step program (two or more 12-step meetings in the past month).

2. 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.

3. Active suicidality (any clinically significant suicide attempts in the past 3 months or any current suicidal intent or definite plan).

4. Current homicidal ideation aimed at a specific person or persons.

5. Medical illness which is severe enough to compromise participation in the study.

6. 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.

7. Expectation of being out of town or in jail for more than 21 days during the treatment period.

8. Expectation of participation in any other formal addiction treatment during the study period (not including TAU, 12-step or other mutual support groups).

9. Current engagement in behavioral health treatment (including case management) at another facility.

10. Current engagement in non-TAU treatment at UNMPC, such as psychotherapy, intensive outpatient treatment, or MET.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Michael Bogenschutz

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael P. Bogenschutz, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico Health Sciences Center

Locations

UNM HSC Department of Psychiatry Clinical Trials

Albuquerque, New Mexico, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23098171 (View on PubMed)

Other Identifiers

R01AA015419

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIH Grant 1R01 AA015419

Identifier Type: -

Identifier Source: secondary_id

NIAAA-Bogenschutz-AA015419

Identifier Type: -

Identifier Source: org_study_id