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Clinical Trials/NCT00996775
NCT00996775
Completed
Phase 3

Implementing Evidence-Based Mental Health Practices in Primary Care

VA Office of Research and Development1 site in 1 country167 target enrollmentDecember 2009

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Alcohol Consumption
Sponsor
VA Office of Research and Development
Enrollment
167
Locations
1
Primary Endpoint
Reduction in Percentage of Heavy Drinking Days
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
August 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Reduction in Percentage of Heavy Drinking Days

Time Frame: 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).

Study Sites (1)

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