Overview

This trial is active, not recruiting.

Condition alcohol misuse
Treatments computerized motivational intervention for alcohol misuse, treatment-as-usual
Phase phase 3
Sponsor Department of Veterans Affairs
Start date December 2009
End date December 2012
Trial size 177 participants
Trial identifier NCT00996775, LIP 62-109

Summary

This research study will examine the effectiveness of a brief, computerized motivational intervention plus treatment-as-usual to treatment-as-usual alone for treating alcohol misuse in veterans presenting to primary care. We aim to recruit 162 veterans screening positive on the AUDIT-C to participate in this study. Participants will be randomly assigned to one of the two intervention conditions and be asked to complete a baseline assessment and two follow-up assessments conducted at three and six months post treatment. Baseline assessments will be conducted in person by a trained research assistant, while all follow-up interviews will be conducted over the phone. The primary outcome for this clinical trial is the reduction in the number of heavy drinking days. Several secondary outcomes will be collected including health status, depressive symptoms, consequences of drinking, pain symptoms, and distress tolerance. The findings from this study may have large scale implications for how alcohol misuse is treated in primary care. In addition, this study will provide evidence for the feasibility of using the computer as a method for delivering evidence-based mental health interventions in primary care.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Group receiving treatment-as-usual.
treatment-as-usual
Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System.
(Experimental)
Group receiving computerized motivational intervention.
computerized motivational intervention for alcohol misuse
A brief, computerized motivational intervention consisting of an assessment and individualized feedback component.
treatment-as-usual
Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System.

Primary Outcomes

Measure
reduction in the misuse of alcohol
time frame: baseline, three and six months post intervention

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - at least 18 years of age, - speak and read English, - U.S. veteran status, - screen positive on the AUDIT-C Exclusion Criteria: - the presence of any cognitive difficulties that interfere with one's ability to consent to study participation

Additional Information

Official title Implementing Evidence-Based Mental Health Practices in Primary Care
Principal investigator Michael A. Cucciare, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.