Health Focused Motivational Treatment for Alcohol Dependent Veterans

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00252590

First Posted: November 11, 2005

Last Update Posted: March 21, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

VA Office of Research and Development

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

Start Date ^ICMJE

November 2005

Primary Completion Date

May 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of Days Abstinent From Alcohol [ Time Frame: 4 months ]

Original Primary Outcome Measures ^ICMJE

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

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

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 Provided

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

Enrollment ^ICMJE

Completion Date

May 2009

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, Senior)

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

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