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Enhanced Motivational Interviewing With Alcohol Positive Trauma Patients

Primary Purpose

Alcohol Abuse, Alcohol Dependence

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Motivational Interview
Assessment
Motivational Interview
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring Motivational Interviewing, Alcohol Abuse, Alcohol Dependence, Emergency Care Setting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rhode Island Hospital
  • Brown University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1) MI with SO

2) MI with patient only

3) Assessment only

Arm Description

Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, with inclusion of a significant other (SO) in prolonged, intensive alcohol treatment.

Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, with the individual patient

In the assessment-only condition, patients will receive only assessment of their drinking at baseline.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cost-effectiveness of intervention

Full Information

First Posted
January 19, 2006
Last Updated
June 24, 2010
Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00280488
Brief Title
Enhanced Motivational Interviewing With Alcohol Positive Trauma Patients
Official Title
Enhanced MI With Alcohol Positive Trauma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2005 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Alcohol Dependence
Keywords
Motivational Interviewing, Alcohol Abuse, Alcohol Dependence, Emergency Care Setting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1) MI with SO
Arm Type
Active Comparator
Arm Description
Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, with inclusion of a significant other (SO) in prolonged, intensive alcohol treatment.
Arm Title
2) MI with patient only
Arm Type
Active Comparator
Arm Description
Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, with the individual patient
Arm Title
3) Assessment only
Arm Type
Active Comparator
Arm Description
In the assessment-only condition, patients will receive only assessment of their drinking at baseline.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interview
Intervention Description
Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.
Intervention Type
Behavioral
Intervention Name(s)
Assessment
Intervention Description
In the assessment-only condition, patients will receive only assessment of their drinking at baseline.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interview
Intervention Description
Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.
Primary Outcome Measure Information:
Title
Alcohol Consumption
Time Frame
12 months
Title
Alcohol-related problems (e.g., drinking and driving)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cost-effectiveness of intervention
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Monti, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

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Enhanced Motivational Interviewing With Alcohol Positive Trauma Patients

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