Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Health Focused Motivational Treatment for Alcohol Dependent Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00252590
First received: November 9, 2005
Last updated: February 19, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention
Alcoholism
Behavioral: Health Motivational Feedback
Behavioral: Health Education
Behavioral: Control - treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Health Focused Motivational Treatment for Alcohol Dependent Veterans

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Percentage of Days Abstinent From Alcohol [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Days Abstinent From All Substances [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Percentage of days abstinent from both alcohol and drugs


Enrollment: 99
Study Start Date: November 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Health Motivational Feedback
Personalized health-related feedback
Behavioral: Health Motivational Feedback
Personalized feedback on health status
Active Comparator: Health Education
Non-personalized didactic health-related education
Behavioral: Health Education
Generalized health education related to alcohol use
Active Comparator: Control - treatment as usual
No added treatment control
Behavioral: Control - treatment as usual
Control group with no additional intervention

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.
  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252590

Locations
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Susan Tate, PhD VA San Diego Healthcare System, San Diego
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00252590     History of Changes
Other Study ID Numbers: NEUA-003-05S 
Study First Received: November 9, 2005
Results First Received: June 25, 2015
Last Updated: February 19, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Psychotherapy motivational intervention

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 26, 2016