Health Focused Motivational Treatment for Alcohol Dependent Veterans

Tracking Information
First Submitted Date ICMJE	November 9, 2005
First Posted Date ICMJE	November 11, 2005
Results First Submitted Date	June 25, 2015
Results First Posted Date	March 21, 2016
Last Update Posted Date	March 21, 2016
Study Start Date ICMJE	November 2005
Actual Primary Completion Date	May 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 19, 2016)	Percentage of Days Abstinent From Alcohol [ Time Frame: 4 months ]
Original Primary Outcome Measures ICMJE; (submitted: November 9, 2005)	Alcohol use over initial four months of treatment , assessed monthly
Change History	Complete list of historical versions of study NCT00252590 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 19, 2016)	Percentage of Days Abstinent From All Substances [ Time Frame: 4 months ]; Percentage of days abstinent from both alcohol and drugs
Original Secondary Outcome Measures ICMJE; (submitted: November 9, 2005)	Drug use and health status over intial four months of treatment, assessed monthly
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Health Focused Motivational Treatment for Alcohol Dependent Veterans
Official Title ICMJE	Health Focused Motivational Treatment for Alcohol Dependent Veterans
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Alcoholism
Intervention ICMJE	Behavioral: Health Motivational Feedback Personalized feedback on health status; Behavioral: Health Education Generalized health education related to alcohol use; Behavioral: Control - treatment as usual Control group with no additional intervention
Study Arms	Experimental: Health Motivational Feedback Personalized health-related feedback Intervention: Behavioral: Health Motivational Feedback; Active Comparator: Health Education Non-personalized didactic health-related education Intervention: Behavioral: Health Education; Active Comparator: Control - treatment as usual No added treatment control Intervention: Behavioral: Control - treatment as usual
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 19, 2016)	99
Original Enrollment ICMJE; (submitted: November 9, 2005)	280
Actual Study Completion Date	May 2009
Actual Primary Completion Date	May 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00252590
Other Study ID Numbers ICMJE	NEUA-003-05S
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	VA Office of Research and Development
Study Sponsor ICMJE	VA Office of Research and Development
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Susan Tate, PhD VA San Diego Healthcare System, San Diego
PRS Account	VA Office of Research and Development
Verification Date	February 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP