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12-step Facilitation for the Dually Diagnosed (TSFDD)

Primary Purpose

Alcoholism, Diagnosis, Dual (Psychiatry)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
12-step facilitation
Treatment as usual
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring 12-step, mutual help, dual diagnosis, serious mental illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UNM HSC Department of Psychiatry Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Percent days abstinent from alcohol

Secondary Outcome Measures

Drinks per drinking day
12-step participation

Full Information

First Posted
December 20, 2007
Last Updated
January 28, 2013
Sponsor
University of New Mexico
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00583440
Brief Title
12-step Facilitation for the Dually Diagnosed
Acronym
TSFDD
Official Title
12-step Facilitation for the Dually Diagnosed
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Diagnosis, Dual (Psychiatry)
Keywords
12-step, mutual help, dual diagnosis, serious mental illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
12-step facilitation
Intervention Description
12 weekly individual 12-step facilitation sessions
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Usual clinical treatment in a dual diagnosis treatment program
Primary Outcome Measure Information:
Title
Percent days abstinent from alcohol
Time Frame
12, 24, 36, and 48 weeks
Secondary Outcome Measure Information:
Title
Drinks per drinking day
Time Frame
12, 24, 36, and 48 weeks
Title
12-step participation
Time Frame
12, 24, 36, and 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P. Bogenschutz, MD
Organizational Affiliation
University of New Mexico Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNM HSC Department of Psychiatry Clinical Trials
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23098171
Citation
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.
Results Reference
derived

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12-step Facilitation for the Dually Diagnosed

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