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

Not Applicable

Recruiting

• Conditions: Substance Dependence; Substance Use; Substance Use Disorders
• Interventions: Behavioral: TeleTx intervention; Behavioral: Enhanced Usual Care (EUC)

• Registration Number: NCT05410561
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-08
• Study Start: 2022-11-01
• Status Verified: 2024-05
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TeleTx intervention	TeleTx intervention	The evidence-based manualized psychosocial program is via telehealth and uses adaptations of cognitive behavioral therapy and motivational interviewing.
Enhanced Usual Care (EUC)	Enhanced Usual Care (EUC)	EUC will include brief psychoeducation about AUD and resources for treatment.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

VA Ann Arbor Health Care | Veterans Affairs; 🇺🇸 Ann Arbor, Michigan, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States