Implementing Evidence-Based Mental Health Practices in Primary Care
Primary Purpose
Alcohol Consumption
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
brief alcohol intervention
standard care
Sponsored by

About this trial
This is an interventional treatment trial for Alcohol Consumption focused on measuring Alcohol Consumption
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
Sites / Locations
- Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standard care only
Brief alcohol intervention
Arm Description
standard care only - harmful effects of alcohol use and NIAAA limits
Group receiving brief alcohol intervention
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT00996775
First Posted
October 14, 2009
Last Updated
November 14, 2016
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00996775
Brief Title
Implementing Evidence-Based Mental Health Practices in Primary Care
Official Title
Implementing Evidence-Based Mental Health Practices in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption
Keywords
Alcohol Consumption
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard care only
Arm Type
Active Comparator
Arm Description
standard care only - harmful effects of alcohol use and NIAAA limits
Arm Title
Brief alcohol intervention
Arm Type
Experimental
Arm Description
Group receiving brief alcohol intervention
Intervention Type
Behavioral
Intervention Name(s)
brief alcohol intervention
Intervention Description
this intervention consists of brief assessment and feedback
Intervention Type
Behavioral
Intervention Name(s)
standard care
Intervention Description
education about harmful effects of alcohol use and NIAAA recommended drinking limits
Primary Outcome Measure Information:
Title
Reduction in Percentage of Heavy Drinking Days
Description
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).
Time Frame
baseline to six-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Cucciare, PhD
Organizational Affiliation
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
City
No. Little Rock
State/Province
Arkansas
ZIP/Postal Code
72114-1706
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
22388536
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. No abstract available.
Results Reference
result
PubMed Identifier
23218847
Citation
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.
Results Reference
result
PubMed Identifier
23490572
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. doi: 10.15288/jsad.2013.74.428.
Results Reference
result
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Implementing Evidence-Based Mental Health Practices in Primary Care
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