NCT02978027

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

3.2 years

First QC Date

November 28, 2016

Last Update Submit

October 10, 2018

Conditions

Keywords

motivational interviewingbrief alcohol intervention in primary care

Outcome Measures

Primary Outcomes (1)

  • Number days Exceeded Recommended Drinking Limits

    30 days

Secondary Outcomes (2)

  • Drinks Per Drinking Day

    30 days

  • Percent Days Abstinent

    30 days

Study Arms (3)

Brief Advice

ACTIVE COMPARATOR

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.

Behavioral: Brief Advice

NIAAA Clinician's Guide

ACTIVE COMPARATOR

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.

Behavioral: NIAAA Clinician's Guide

Motivational Interviewing (MI)

EXPERIMENTAL

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.

Behavioral: Motivational Interviewing (MI)

Interventions

Brief AdviceBEHAVIORAL
Brief Advice
NIAAA Clinician's Guide
Motivational Interviewing (MI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

  • Hettema JE, Cockrell SA, Reeves A, Ingersoll KS, Lum PJ, Saitz R, Murray-Krezan CM, Carrejo VA. Development and differentiability of three brief interventions for risky alcohol use that include varying doses of motivational interviewing. Addict Sci Clin Pract. 2018 Feb 27;13(1):6. doi: 10.1186/s13722-017-0102-0.

MeSH Terms

Conditions

Alcoholism

Interventions

Crisis InterventionMotivational Interviewing

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesDirective CounselingCounselingMental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jennifer Hettema, PhD

    The University of New Mexico Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2016

First Posted

November 30, 2016

Study Start

July 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations