Enhanced Motivational Interviewing With Alcohol Positive Trauma Patients
Recruitment status was Active, not recruiting
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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 |
- 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 ]
- 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 |
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| United States, Rhode Island | |
| Brown University | |
| Providence, Rhode Island, United States, 02912 | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| 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 Substance-Related Disorders Mental Disorders Ethanol Anti-Infective Agents, Local |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013