Implementing Evidence-Based Mental Health Practices in Primary Care

Phase 3

Completed

• Conditions: Alcohol Consumption
• Interventions: Behavioral: standard care; Behavioral: brief alcohol intervention

• Registration Number: NCT00996775
• Lead Sponsor: VA Office of Research and Development

Brief 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. The investigators 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-10-14
• Study First Posted: 2009-10-16
• Study Start: 2009-12
• Primary Completion: 2012-12
• Results First Submitted: 2014-07-22
• Results First Submitted QC: 2014-08-28
• Results First Posted: 2014-09-01
• Study Completion: 2016-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2017-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard care only	standard care	standard care only - harmful effects of alcohol use and NIAAA limits
Brief alcohol intervention	brief alcohol intervention	Group receiving brief alcohol intervention

Primary Outcome Measures

Name	Time	Method
Reduction in Percentage of Heavy Drinking Days	baseline to six-month follow-up	reduction in the percentage of heavy drinking days over the prior 30-days.; a heavy drinking day was defined as drinking above gender-matched NIAAA drinking limits (e.g., greater than 4 drinks on one occasion for men).

Trial Locations

Locations (1)

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR; 🇺🇸 No. Little Rock, Arkansas, United States