Clinical trial NCT02978027: Mentored Research on Improving Alcohol Brief Interventions in Medical Settings
Official title: Mentored Research on Improving Alcohol Brief Interventions in Medical Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Keywords: motivational interviewing
brief alcohol intervention in primary care
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2016-11-30
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number days Exceeded Recommended Drinking Limits
timeFrame: 30 days
Secondary outcomes:
measure: Drinks Per Drinking Day
timeFrame: 30 days
measure: Percent Days Abstinent
timeFrame: 30 days
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: The University of New Mexico
state: New Mexico
Study officials:
affiliation: The University of New Mexico Health Sciences Center
name: Jennifer Hettema, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.