NCT00996775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 1, 2014

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 2, 2017

Status Verified

November 1, 2016

Enrollment Period

3 years

First QC Date

October 14, 2009

Results QC Date

July 22, 2014

Last Update Submit

November 14, 2016

Conditions

Alcohol Consumption

Keywords

Alcohol Consumption

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

standard care only

ACTIVE COMPARATOR

standard care only - harmful effects of alcohol use and NIAAA limits

Behavioral: standard care

Brief alcohol intervention

EXPERIMENTAL

Group receiving brief alcohol intervention

Behavioral: brief alcohol intervention

Interventions

brief alcohol interventionBEHAVIORAL

this intervention consists of brief assessment and feedback

Brief alcohol intervention
standard careBEHAVIORAL

education about harmful effects of alcohol use and NIAAA recommended drinking limits

standard care only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years of age,
  • speak and read English,
  • U.S. Veteran status,
  • screen positive on the AUDIT-C

You may not qualify if:

  • the presence of any cognitive difficulties that interfere with one's ability to consent to study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

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

Location

Related Publications (3)

  • 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.

    PMID: 22388536RESULT

  • 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.

    PMID: 23218847RESULT

  • 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.

    PMID: 23490572RESULT

MeSH Terms

Conditions

Alcohol Drinking

Interventions

EthanolMethodsStandard of Care

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsInvestigative TechniquesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Michael A. Cucciare, Ph.D.
Organization
Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Healthcare System
michael.cucciare@va.gov
501-257-1068

Study Officials

  • Michael A Cucciare, PhD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2009

First Posted

October 16, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2012

Study Completion

August 1, 2016

Last Updated

January 2, 2017

Results First Posted

September 1, 2014

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)