Implementing Evidence-Based Mental Health Practices in Primary Care

Alcohol Consumption Clinical Trial

Official title:

Implementing Evidence-Based Mental Health Practices in Primary Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00996775
• Other study ID #: LIP 62-109
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 14, 2009
• Last updated: January 6, 2016
• Start date: December 2009
• Est. completion date: August 2016

Study information

• Verified date: January 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

please see the brief summary

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 167
• Est. completion date: August 2016
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking

Intervention

Behavioral:
• brief alcohol intervention
this intervention consists of brief assessment and feedback
• standard care
education about harmful effects of alcohol use and NIAAA recommended drinking limits

Locations

Country	Name	City	State
United States	Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR	No. Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cucciare MA, Boden MT, Weingardt KR. Brief alcohol counseling improves mental health functioning in veterans with alcohol misuse: results from a randomized trial. J Affect Disord. 2013 May;147(1-3):312-7. doi: 10.1016/j.jad.2012.11.028. Epub 2012 Dec 6. — View Citation

Cucciare MA, Ghaus S. A Web-based intervention for alcohol misuse in VA primary care. Psychiatr Serv. 2012 Mar;63(3):292. doi: 10.1176/appi.ps.20120p292. — View Citation

Cucciare MA, Weingardt KR, Ghaus S, Boden MT, Frayne SM. A randomized controlled trial of a web-delivered brief alcohol intervention in Veterans Affairs primary care. J Stud Alcohol Drugs. 2013 May;74(3):428-36. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Percentage of Heavy Drinking Days	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).	baseline to six-month follow-up	No