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Clinical Trials/NCT00280488
NCT00280488
Unknown
Phase 3

Enhanced MI With Alcohol Positive Trauma Patients

Brown University2 sites in 1 country300 target enrollmentMay 2005

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Alcohol Abuse
Sponsor
Brown University
Enrollment
300
Locations
2
Primary Endpoint
Alcohol Consumption
Last Updated
15 years ago

Overview

Brief Summary

The primary goal of this study is to test the efficacy of a brief intervention that includes the patient and a significant other, relative to an intervention including the patient only, for reducing alcohol use and alcohol-related problems among trauma patients.

Detailed Description

Alcohol-positive trauma patients are more likely to be readmitted to a trauma center or subsequently die from an injury than are alcohol-negative patients. Empirically supported treatments to reduce alcohol use and alcohol-related problems (e.g., injuries, drinking and driving) in this high-risk population are needed, but few exist. This randomized controlled clinical trial assesses the efficacy of a brief intervention that includes the patient and a significant other, relative to an intervention including the patient only, for reducing alcohol use and alcohol-related problems among trauma patients. Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, has demonstrated some promise in this setting. Further, inclusion of a significant other (SO) in prolonged, intensive alcohol treatment appears to improve treatment retention and efficacy. Although inclusion of an SO in MI has been suggested, there are few data to support this endorsement. Accordingly, this study will address whether motivational interviewing including both the trauma patient and an SO can more effectively decrease and maintain reductions in alcohol use and alcohol-related problems 6 and 12 months following discharge from the trauma unit than MI with the individual patient or an assessment-only condition. The 2 MI groups will each receive 2 intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge. In the assessment-only condition, patients will receive only assessment of their drinking at baseline. This proposal will allow us to address the next phase of our program of research designed to develop easily disseminable treatments for these high-risk populations in medical settings. This study will also address potential mediators (motivation to change alcohol use, self-efficacy, alcohol treatment attendance, and social support for abstinence) and moderators of MI effects. The cost-effectiveness of the intervention will also be addressed. Thus, this study will address both a significant public health problem and provide important information about MI mechanisms that may be relevant to the broader addiction treatment community.

Registry
clinicaltrials.gov
Start Date
May 2005
End Date
April 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • admitted to trauma unit
  • greater than 18 years old
  • had a blood alcohol concentration (BAC) greater than .01% according to a biochemical test OR self-reported drinking alcohol in the 6 hours prior to the event that caused their hospital visit OR scored 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT)
  • identify at least one eligible significant other

Exclusion Criteria

  • not English-speaking
  • had a self-inflicted injury
  • in police custody
  • did not pass a mental status exam

Outcomes

Primary Outcomes

Alcohol Consumption

Time Frame: 12 months

Alcohol-related problems (e.g., drinking and driving)

Time Frame: 12 months

Secondary Outcomes

  • Cost-effectiveness of intervention(12 months)

Study Sites (2)

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