Overview

This trial is active, not recruiting.

Conditions alcohol abuse, alcohol dependence
Treatments motivational interview, assessment
Phase phase 3
Sponsor Brown University
Collaborator National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date May 2005
End date April 2011
Trial size 300 participants
Trial identifier NCT00280488, 3R01AA009892-15S1, NIAAAMON-009892-11A1, NIH grant AA009892-11A1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, with inclusion of a significant other (SO) in prolonged, intensive alcohol treatment.
motivational interview
Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.
(Active Comparator)
Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, with the individual patient
motivational interview
Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.
(Active Comparator)
In the assessment-only condition, patients will receive only assessment of their drinking at baseline.
assessment
In the assessment-only condition, patients will receive only assessment of their drinking at baseline.

Primary Outcomes

Measure
Alcohol Consumption
time frame: 12 months
Alcohol-related problems (e.g., drinking and driving)
time frame: 12 months

Secondary Outcomes

Measure
Cost-effectiveness of intervention
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Enhanced MI With Alcohol Positive Trauma Patients
Principal investigator Peter Monti, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by Brown University.