12-step Facilitation for the Dually Diagnosed (TSFDD)
January 28, 2013 updated by: Michael Bogenschutz, University of New Mexico
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.
Study Overview
Status
Completed
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Actual)
121
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- UNM HSC Department of Psychiatry Clinical Trials
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: 2
|
Usual clinical treatment in a dual diagnosis treatment program
|
|
EXPERIMENTAL: 1
|
12 weekly individual 12-step facilitation sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent days abstinent from alcohol
Time Frame: 12, 24, 36, and 48 weeks
|
12, 24, 36, and 48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Drinks per drinking day
Time Frame: 12, 24, 36, and 48 weeks
|
12, 24, 36, and 48 weeks
|
|
12-step participation
Time Frame: 12, 24, 36, and 48 weeks
|
12, 24, 36, and 48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael P. Bogenschutz, MD, University of New Mexico Health Sciences Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (ACTUAL)
September 1, 2010
Study Completion (ACTUAL)
May 1, 2011
Study Registration Dates
First Submitted
December 20, 2007
First Submitted That Met QC Criteria
December 20, 2007
First Posted (ESTIMATE)
December 31, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
January 30, 2013
Last Update Submitted That Met QC Criteria
January 28, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIAAA-Bogenschutz-AA015419
- R01AA015419 (NIH)
- NIH Grant 1R01 AA015419
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.