Implementing Evidence-Based Mental Health Practices in Primary Care

• ClinicalTrials.gov Identifier: NCT00996775
• Recruitment Status: Completed
• First Posted: October 16, 2009
• Results First Posted: September 1, 2014
• Last Update Posted: January 2, 2017
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alcohol Consumption	Behavioral: brief alcohol intervention; Behavioral: standard care	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 167 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Implementing Evidence-Based Mental Health Practices in Primary Care
• Study Start Date: December 2009
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: August 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: standard care only; standard care only - harmful effects of alcohol use and NIAAA limits	Behavioral: standard care; education about harmful effects of alcohol use and NIAAA recommended drinking limits
Experimental: Brief alcohol intervention; Group receiving brief alcohol intervention	Behavioral: brief alcohol intervention; this intervention consists of brief assessment and feedback

Outcome Measures

Primary Outcome Measures :

1. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Arkansas

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

No. Little Rock, Arkansas, United States, 72114-1706

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Michael A Cucciare, PhD; Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

More Information

Publications of Results:

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.

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.

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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00996775
• Other Study ID Numbers: LIP 62-109
• First Posted: October 16, 2009
• Results First Posted: September 1, 2014
• Last Update Posted: January 2, 2017
• Last Verified: November 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: This project will include data from 167 Veterans screening positive for alcohol misuse (without and without posttraumatic stress disorder [PTSD] or depression). Data was collected at three time points including baseline, 3- and 6-month follow-up. The final dataset includes quantitative data including on alcohol consumption, and symptoms of PTSD, and depression. The final dataset will be stripped of identifiers prior to sharing. Release of data for data sharing will occur after publication of the main findings from the dataset. The investigators will make the data and associated documentation available to users under our own auspices by mailing an encrypted hard-drive to users. A data-sharing agreement must be signed that accounts for (1) commitment to using the data only for research; (2) IRB approval at the host institution, (3) a plan for securing the data using appropriate technology, and (4) an agreed upon plan to destroy or return the data upon completion.

Keywords provided by VA Office of Research and Development:

Alcohol Consumption

Additional relevant MeSH terms:

Alcohol Drinking; Drinking Behavior