Mentored Research on Improving Alcohol Brief Interventions in Medical Settings

October 10, 2018 updated by: University of New Mexico
The NIAAA estimates that 16% (40 million) of adults in the US are drinking at unsafe levels. 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. 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. 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 Overview

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

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • The University of New Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jennifer Hettema, PhD, The University of New Mexico Health Sciences Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

November 30, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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