- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02978027
Mentored Research on Improving Alcohol Brief Interventions in Medical Settings
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The NIAAA estimates that 16% (40 million) of adults in the US are drinking at unsafe levels, placing them at risk for a variety of physical, mental health, and social consequences. More than 50% of alcohol health consequences occur in risky, non-dependent drinkers. Increasing the efficacy and efficiency of brief interventions in medical setting could significantly reduce the public health impacts of risky drinking. Despite overall positive findings for brief interventions, there are high levels of variability in effects, with meta-analyses reporting significant unexplained heterogeneity in outcomes that is likely accounted for by differences in intervention components and strategies. There is intense interest in conducting motivational interviewing (MI) informed brief interventions for risky alcohol use in medical settings, but little empirical information is available regarding which MI behavioral and interpersonal style components drive effectiveness.
Following promising efficacy trials from counseling applications, MI was translated into brief (5-15 minute) interactions and subjected to randomized controlled trial methodology. Lack of mixed-methods, Stage 1 treatment development is evidenced by our inability to provide consistent delineation of key intervention components and mechanisms of action. Variability in these factors is likely responsible for the wide variability in effects observed in meta-analyses of brief interventions. Many MI skills and behaviors require significant training and supervision and increased patient-provider interaction time. The field would benefit greatly from empirically-based Stage 1 treatment development and modeling studies to delineate the degree to which adding motivational interviewing components to brief intervention improves outcome.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- The University of New Mexico
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: patient in University of New Mexico Family and Community Medicine Clinic (e.g. Family Practice, Southeast Height, Northeast Height, University Clinic, South Valley), positive NIAAA single question screen (>0), AUDIT-C score <7, >18 years old, ability to read and speak English, and willing to be contacted for follow-up.
Exclusion Criteria: active suicidality, incarceration, obvious cognitive impairment, unable to provide informed consent, current involvement in an alcohol research study or people who are specifically seeking help for alcohol problems, and pregnancy or intent to become pregnant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Brief Advice
The brief advice protocol was designed by removing MI-consistent elements from the NIAAA Clinician's Guide.
The protocol involves screening and assessment using the NIAAA pre-screen and single-question screen and assessing for quantity and frequency.
Patients exceeding recommended limits receive feedback, information, and advice to cut down drinking to recommended levels.
All patients are provided with a tip sheet on strategies for cutting down and encouraged to follow-up with a behavioral health provider with any questions or concerns.
|
|
Active Comparator: NIAAA Clinician's Guide
The NIAAA brief intervention was adapted directly from the NIAAA publication "Helping Patients Who Drink Too Much: A Clinician's Guide".
The protocol screens using the NIAAA pre-screen and single-questions.
Patients exceeding recommended limits receive feedback, information, and advice to cut down.
For patients unwilling to make a change, the clinician restates their concern, encourages self reflection by asking the patient about reasons to cut down on drinking and barriers to change, and reaffirms willingness to help.
For patients willing to make a change, the clinician helps the patient develop a plan to cut down within maximum limits, agree on specific steps and strategies, and provides a tip sheet on strategies for cutting down.
|
|
Experimental: Motivational Interviewing (MI)
The MI intervention condition was also adapted from the NIAAA Clinician's Guide, with additional modification to include elements of MI.
Clinicians normalize Screening and Brief Intervention (SBI) and ask the patient's permission before discussing alcohol use.
The NIAAA pre-screen and single-question screen are administered.
Assessment of quantity, frequency, and Alcohol Use Disorder symptoms is done using open questions.
The ask-tell-ask technique is used to share feedback and exchange information regarding U.S adult drinking patterns.
For patients low in readiness to make a change, clinicians build readiness using structured MI tools.
For patients high in readiness to change, the ask-tell-ask technique is used to explore strategies for cutting down and develop an action plan.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number days Exceeded Recommended Drinking Limits
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Drinks Per Drinking Day
Time Frame: 30 days
|
30 days
|
Percent Days Abstinent
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer Hettema, PhD, The University of New Mexico Health Sciences Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23AA020865 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Abuse
-
The Morton Center, Inc.National Institute on Alcohol Abuse and Alcoholism (NIAAA)UnknownAlcohol Dependence | Cannabis Dependence | Alcohol Abuse | Cannabis Abuse | Other Substance AbuseUnited States
-
Michael E. DeBakey VA Medical CenterUnknownAlcohol Dependence | Alcohol Abuse | Substance Abuse ProblemUnited States
-
Polaris Health DirectionsUniversity of Massachusetts, WorcesterCompletedAlcohol Abuse, Alcohol DependenceUnited States
-
Kent State UniversityCompletedAlcohol Use Disorder | Alcohol Abuse | Alcohol Abuse, EpisodicUnited States
-
Australian National UniversityUniversity of Peradeniya; Department of Foregin Affairs and Trade, AustraliaCompletedIntimate Partner Violence | Domestic Abuse | Drug and Alcohol AbuseAustralia
-
National Institute on Drug Abuse (NIDA)CompletedDrug/Substance Abuse/Addiction | Alcohol Abuse/AddictionUnited States
-
Queen Mary University of LondonBarts & The London NHS Trust; University of HertfordshireRecruitingAlcohol Use Disorder | Alcohol Abuse or DependenceUnited Kingdom
-
National Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Drug Abuse | Alcohol AbuseUnited States
-
Baylor College of MedicineCompletedAlcohol Dependence | Substance Abuse | Alcohol AbuseUnited States
-
Fundació Sant Joan de DéuInstituto de Salud Carlos III; European Union; University of Barcelona; Red Salud...UnknownAlcohol Abuse in PregnancySpain
Clinical Trials on Brief Advice
-
University of Texas at AustinNational Institute on Drug Abuse (NIDA)Completed
-
Yale UniversityNational Institute on Drug Abuse (NIDA)CompletedMarijuana Abuse | Alcohol Abuse | Cocaine AbuseUnited States
-
Clinica Universidad de Navarra, Universidad de...University of NavarraCompletedSmoking | Smoking CessationSpain
-
University of British ColumbiaNational Institutes of Health (NIH)Completed
-
Washington University School of MedicineNational Institute on Drug Abuse (NIDA)CompletedSmoking Cessation | Tobacco Use Disorder | Tobacco Use CessationUnited States
-
Boston Children's HospitalPearl NetworkWithdrawnDrug Abuse | Alcohol Abuse | Tobacco AbuseUnited States
-
Pennsylvania Department of HealthChildren's Hospital of Philadelphia; University of Pittsburgh; Lehigh Valley...Unknown
-
Basque Health ServiceCompletedSmoking Cessation | COPDSpain
-
University of ChicagoTerminated