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Implementing Evidence-Based Mental Health Practices in Primary Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00996775
First Posted: October 16, 2009
Last Update Posted: January 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  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. 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.

Condition Intervention Phase
Alcohol Consumption Behavioral: brief alcohol intervention Behavioral: standard care Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 VA Office of Research and Development:

Primary Outcome Measures:
  • Reduction in Percentage of Heavy Drinking Days [ Time Frame: baseline to six-month follow-up ]

    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
Study Completion Date: August 2016
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996775


Locations
United States, Arkansas
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
No. Little Rock, Arkansas, United States, 72114-1706
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Michael A Cucciare, PhD Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00996775     History of Changes
Other Study ID Numbers: LIP 62-109
First Submitted: October 14, 2009
First Posted: October 16, 2009
Results First Submitted: July 22, 2014
Results First Posted: September 1, 2014
Last Update Posted: January 2, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by VA Office of Research and Development:
Alcohol Consumption

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