Health Focused Motivational Treatment for Alcohol Dependent Veterans
Primary Purpose
Alcoholism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Motivational Feedback
Health Education
Control - treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism focused on measuring Psychotherapy motivational intervention
Eligibility Criteria
Inclusion Criteria: - Veterans receiving outpatient treatment at the VA San Diego Healthcare System Alcohol and Drug Treatment Program for a diagnosis of Alcohol Dependence Exclusion Criteria: Diagnosis of Bipolar Disorder or Psychotic Disorder.
Sites / Locations
- VA San Diego Healthcare System, San Diego
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Health Motivational Feedback
Health Education
Control - treatment as usual
Arm Description
Personalized health-related feedback
Non-personalized didactic health-related education
No added treatment control
Outcomes
Primary Outcome Measures
Percentage of Days Abstinent From Alcohol
Secondary Outcome Measures
Percentage of Days Abstinent From All Substances
Percentage of days abstinent from both alcohol and drugs
Full Information
NCT ID
NCT00252590
First Posted
November 9, 2005
Last Updated
February 19, 2016
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00252590
Brief Title
Health Focused Motivational Treatment for Alcohol Dependent Veterans
Official Title
Health Focused Motivational Treatment for Alcohol Dependent Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether a health focused motivational intervention will reduce alcohol use for dependent veterans who are receiving outpatient alcohol and drug treatment.
Detailed Description
The early months of addiction treatment are a high risk time for relapse. The purpose of this study is to examine whether a health-related intervention delivered in an individual session with a therapist once per month in the initial 4 months of addiction treatment will reduce alcohol use among veterans already enrolled in weekly outpatient treatment group at the VA San Diego Healthcare System. In order to answer this question, study participants will be randomly assigned to one of three study conditions: 1) The Health Motivational condition that receives individual personalized health feedback and motivational activities, 2) the Health Education condition that receives individual education about health problems associated with the heavy alcohol use, and 3) the treatment as usual group that will receive no additional treatment. All participants will be assessed on a monthly basis for 4 months to evaluate alcohol use, drug use, and health status.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Psychotherapy motivational intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Health Motivational Feedback
Arm Type
Experimental
Arm Description
Personalized health-related feedback
Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
Non-personalized didactic health-related education
Arm Title
Control - treatment as usual
Arm Type
Active Comparator
Arm Description
No added treatment control
Intervention Type
Behavioral
Intervention Name(s)
Health Motivational Feedback
Intervention Description
Personalized feedback on health status
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Generalized health education related to alcohol use
Intervention Type
Behavioral
Intervention Name(s)
Control - treatment as usual
Intervention Description
Control group with no additional intervention
Primary Outcome Measure Information:
Title
Percentage of Days Abstinent From Alcohol
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Percentage of Days Abstinent From All Substances
Description
Percentage of days abstinent from both alcohol and drugs
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Veterans receiving outpatient treatment at the VA San Diego Healthcare System Alcohol and Drug Treatment Program for a diagnosis of Alcohol Dependence
Exclusion Criteria:
Diagnosis of Bipolar Disorder or Psychotic Disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Tate, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
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Health Focused Motivational Treatment for Alcohol Dependent Veterans
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