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Implementing Evidence-Based Mental Health Practices in Primary Care

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00996775
First received: October 14, 2009
Last updated: August 28, 2014
Last verified: August 2014
  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 Drinking
Behavioral: brief alcohol intervention
Behavioral: standard care
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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Reduction in Percentage of Heavy Drinking Days [ Time Frame: baseline to six-month follow-up ] [ Designated as safety issue: No ]

    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).



Enrollment: 167
Study Start Date: December 2009
Estimated Study Completion Date: August 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

please see the brief summary

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996775

Sponsors and Collaborators
Investigators
Principal Investigator: Michael A. Cucciare, PhD Central Arkansas Veterans Healthcare System (North Little Rock)
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00996775     History of Changes
Other Study ID Numbers: LIP 62-109
Study First Received: October 14, 2009
Results First Received: July 22, 2014
Last Updated: August 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Alcohol Drinking

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014