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| Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
|---|---|
| Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| ClinicalTrials.gov Identifier: | NCT00280488 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Enhanced MI With Alcohol Positive Trauma Patients |
| Estimated Enrollment: | 300 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1) MI with SO: Active Comparator
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.
|
|
2) MI with patient only: Active Comparator
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.
|
|
3) Assessment only: Active Comparator
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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Chad J. Gwaltney, PhD | 401-444-1897 | chad_gwaltney@brown.edu |
| Contact: Peter Monti, PhD | 401-444-1828 | peter_monti@brown.edu |
| United States, Rhode Island | |
| Brown University | Recruiting |
| Providence, Rhode Island, United States, 02912 | |
| Contact: Chad J. Gwaltney, PhD 401-444-1897 chad_gwaltney@brown.edu | |
| Principal Investigator: Peter Monti, PhD | |
| Rhode Island Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Chad J. Gwaltney, PhD 401-444-1897 chad_gwaltney@brown.edu | |
| Principal Investigator: Peter Monti, PhD | |
| Principal Investigator: | Peter Monti, PhD | Brown University |
More Information
| Responsible Party: | Brown University ( Peter Monti, Ph.D., Principal Investigator ) |
| Study ID Numbers: | NIAAAMON-009892-11A1, NIH grant AA009892-11A1 |
| Study First Received: | January 19, 2006 |
| Last Updated: | September 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00280488 |
| Health Authority: | United States: Federal Government |
|
Motivational Interviewing Alcohol Abuse Alcohol Dependence Emergency Care Setting |
|
Mental Disorders Alcoholism Substance-Related Disorders Wounds and Injuries |
Disorders of Environmental Origin Emergencies Alcohol-Related Disorders Ethanol |
