Implementing Evidence-Based Mental Health Practices in Primary Care

NCT ID: NCT00996775

Last Updated: 2017-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2016-08-31

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.

Conditions

Alcohol Consumption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard care only

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

Group Type: ACTIVE_COMPARATOR

standard care

Intervention Type: BEHAVIORAL

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

Brief alcohol intervention

Group receiving brief alcohol intervention

Group Type: EXPERIMENTAL

brief alcohol intervention

Intervention Type: BEHAVIORAL

this intervention consists of brief assessment and feedback

Interventions

brief alcohol intervention

this intervention consists of brief assessment and feedback

Intervention Type: BEHAVIORAL

standard care

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael A Cucciare, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

No. Little Rock, Arkansas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22388536 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23218847 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23490572 (View on PubMed)

Other Identifiers

LIP 62-109

Identifier Type: -

Identifier Source: org_study_id