Enhanced Motivational Interviewing With Alcohol Positive Trauma Patients

Alcohol Dependence Clinical Trial

Official title:

Enhanced MI With Alcohol Positive Trauma Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00280488
• Other study ID #: NIAAAMON-009892-11A1
• Secondary ID: 3R01AA009892-15S
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 19, 2006
• Last updated: June 24, 2010
• Start date: May 2005
• Est. completion date: April 2011

Study information

• Verified date: June 2010
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Dependence
• Alcoholism

Intervention

Behavioral:
• Motivational Interview
Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.
• Assessment
In the assessment-only condition, patients will receive only assessment of their drinking at baseline.
• Motivational Interview
Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol Consumption		12 months	No
Primary	Alcohol-related problems (e.g., drinking and driving)		12 months	No
Secondary	Cost-effectiveness of intervention		12 months	No