Implementing Evidence-Based Mental Health Practices in Primary Care
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Purpose
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. We 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 | Intervention | Phase |
|---|---|---|
|
Alcohol Misuse |
Behavioral: Computerized Motivational Intervention for Alcohol Misuse Behavioral: Treatment-as-Usual |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Implementing Evidence-Based Mental Health Practices in Primary Care |
- reduction in the misuse of alcohol [ Time Frame: baseline, three and six months post intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 177 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1
Group receiving treatment-as-usual.
|
Behavioral: Treatment-as-Usual
Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System.
|
|
Experimental: Arm 2
Group receiving computerized motivational intervention.
|
Behavioral: Computerized Motivational Intervention for Alcohol Misuse
A brief, computerized motivational intervention consisting of an assessment and individualized feedback component.
Behavioral: Treatment-as-Usual
Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
More Information
Publications:
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00996775 History of Changes |
| Other Study ID Numbers: | CDP 10-045 |
| Study First Received: | October 14, 2009 |
| Last Updated: | March 20, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Alcohol Drinking |
ClinicalTrials.gov processed this record on May 23, 2013