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

NCT05410561 | Active Not Recruiting

• 2 other identifiers: HUM002043151R01AA029400-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Substance Use Disorders; Substance Use; Substance Dependence

Keywords

Telehealth; Cognitive behavioral therapy; Psychoeducation; Motivational interviewing; Alcohol consumption

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (11)

• Total Alcohol Use Disorder Psychotherapy Treatment Attendance

  6-months

• Total Alcohol Use Disorder Psychotherapy Treatment Attendance

  12-months

• Drinking Risk Levels (Based on World Health Organization Cut-Offs)

  Baseline to 3-months

• Drinking Risk Levels (Based on World Health Organization Cut-Offs)

  Baseline to 6-months

• Drinking Risk Levels (Based on World Health Organization Cut-Offs)

  Baseline to 12-months

Study Arms (2)

TeleTx intervention

EXPERIMENTAL

The evidence-based manualized psychosocial program is via telehealth and uses adaptations of cognitive behavioral therapy and motivational interviewing.

Behavioral: TeleTx intervention

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

EUC will include brief psychoeducation about AUD and resources for treatment.

Behavioral: Enhanced Usual Care (EUC)

Interventions

Enhanced Usual Care (EUC) BEHAVIORAL

EUC will comprise one session of brief psychoeducation and referral information to alcohol use disorder (AUD) treatment.

Enhanced Usual Care (EUC)

TeleTx intervention BEHAVIORAL

TeleTx will consist of an initial session and then 8 \~counseling sessions.

TeleTx intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

VA Ann Arbor Health Care | Veterans Affairs

Ann Arbor, Michigan, 48105, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 38679140 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Alcohol Drinking

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Study Officials

• Allison Lin, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Erin Bonar, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 8, 2022
• Study Start: November 1, 2022
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)