Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Enhanced Motivational Interviewing With Alcohol Positive Trauma Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Brown University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Brown University
ClinicalTrials.gov Identifier:
NCT00280488
First received: January 19, 2006
Last updated: June 24, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Alcohol Abuse
Alcohol Dependence
Behavioral: Motivational Interview
Behavioral: Assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enhanced MI With Alcohol Positive Trauma Patients

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Alcohol Consumption [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Alcohol-related problems (e.g., drinking and driving) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost-effectiveness of intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2005
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1) MI with SO
Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, with inclusion of a significant other (SO) in prolonged, intensive alcohol treatment.
Behavioral: Motivational Interview
Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.
Active Comparator: 2) MI with patient only
Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, with the individual patient
Behavioral: Motivational Interview
Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.
Active Comparator: 3) Assessment only
In the assessment-only condition, patients will receive only assessment of their drinking at baseline.
Behavioral: Assessment
In the assessment-only condition, patients will receive only assessment of their drinking at baseline.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280488

Locations
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Peter Monti, PhD Brown University
  More Information

No publications provided

Responsible Party: Peter Monti, Ph.D., Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT00280488     History of Changes
Other Study ID Numbers: NIAAAMON-009892-11A1, 3R01AA009892-15S1, NIH grant AA009892-11A1
Study First Received: January 19, 2006
Last Updated: June 24, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Brown University:
Motivational Interviewing
Alcohol Abuse
Alcohol Dependence
Emergency Care Setting

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014