Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients

The purpose of this trial is to test new programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. The program sessions focus on getting to know what's important to the participants, reviewing or setting goals, and using different skills and behaviors to better manage health. The trial will help the study team learn about ways to deliver health information in a way that is useful and interesting.

This research will take place remotely (e.g., Zoom, Facetime, Phone) and participants will be randomized to the Telehealth (TeleTx) group intervention or the Enhanced Usual Care (EUC) control group. Both groups will be asked to have follow-up visits up to 12 months from the baseline visit.

Study Overview

• Status: Active, not recruiting
• Conditions: Substance Use; Substance Use Disorders; Substance Dependence
• Intervention / Treatment: Behavioral: TeleTx intervention; Behavioral: Enhanced Usual Care (EUC)

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Ann Arbor, Michigan, United States, 48105
      • VA Ann Arbor Health Care | Veterans Affairs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Current Diagnostic and Statistical Manual (DSM) -5 alcohol use disorder (AUD) based on alcohol symptom checklist
• An average of 3 or more drinking days per week for the past 30 days
• Have regular access to a device with video capabilities or a phone to use for study related calls

Exclusion Criteria:

• Inability to speak or understand English
• Conditions that preclude informed consent or understanding of assessment or intervention content
• Past 90-day AUD psychotherapy treatment,
• At elevated risk for complicated alcohol withdrawal
• Past-year drug injection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TeleTx intervention; The evidence-based manualized psychosocial program is via telehealth and uses adaptations of cognitive behavioral therapy and motivational interviewing.	Behavioral: TeleTx intervention; TeleTx will consist of an initial session and then 8 ~counseling sessions.
Active Comparator: Enhanced Usual Care (EUC); EUC will include brief psychoeducation about AUD and resources for treatment.	Behavioral: Enhanced Usual Care (EUC); EUC will comprise one session of brief psychoeducation and referral information to alcohol use disorder (AUD) treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use Disorder Treatment Initiation	Percent of patients who initiate Alcohol Use Disorder psychotherapy treatment	3 months
Alcohol Use Disorder Treatment Engagement	Percent of patients who attend at least 2 additional Alcohol Use Disorder psychotherapy sessions	3 months
Alcohol consumption days	Percent days of alcohol use on the Timeline Follow Back interview	3-months
Alcohol consumption days	Percent days of alcohol use on the Timeline Follow Back interview	6-months
Alcohol consumption days	Percent days of alcohol use on the Timeline Follow Back interview	12-months
Heavy drinking days	Percent days heavy drinking on the Timeline Follow Back interview	3-months
Heavy drinking days	Percent days heavy drinking on the Timeline Follow Back interview	6-months
Heavy drinking days	Percent days heavy drinking on the Timeline Follow Back interview	12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Alcohol Use Disorder Psychotherapy Treatment Attendance	Total number of psychotherapy sessions	6-months
Total Alcohol Use Disorder Psychotherapy Treatment Attendance	Total number of psychotherapy sessions	12-months
Drinking Risk Levels (Based on World Health Organization Cut-Offs)	Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes)	Baseline to 3-months
Drinking Risk Levels (Based on World Health Organization Cut-Offs)	Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes)	Baseline to 6-months
Drinking Risk Levels (Based on World Health Organization Cut-Offs)	Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes)	Baseline to 12-months
World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)	Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life.	Baseline to 3-months
World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)	Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life.	Baseline to 6-months
World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)	Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life.	Baseline to 12-months
Alcohol consequences	Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R	Baseline to 3-months
Alcohol consequences	Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R	Baseline to 6-months
Alcohol consequences	Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R	Baseline to 12-months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Allison Lin, MD, University of Michigan; Principal Investigator: Erin Bonar, PhD, University of Michigan

Publications and helpful links

General Publications

• Bonar EE, Goldstick JE, Rostker MJ, Dailey SE, Augustiniak AN, Brin C, Manderachia DA, Bourque C, Girard R, Sulkowski L, Lin LA. Testing a new model of telehealth-delivered treatment for primary care patients with alcohol use disorder: A randomized controlled trial protocol. Contemp Clin Trials. 2024 Jul;142:107549. doi: 10.1016/j.cct.2024.107549. Epub 2024 Apr 26.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Motivational interviewing; Cognitive behavioral therapy; Telehealth; Psychoeducation; Alcohol consumption
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Behavior; Alcohol Drinking; Substance-Related Disorders
• Other Study ID Numbers: HUM00204315; 1R01AA029400-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No