Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders

NCT05594238 | Active Not Recruiting DMC

• 2 other identifiers: HUM00210546R01AA029808
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alcohol Use Disorder

Keywords

Telehealth

Outcome Measures

Primary Outcomes (8)

• AUD Treatment Initiation

  % of patients who initiate psychotherapy treatment

  4-months post-enrollment

• AUD Treatment Engagement

  % of patients who attend at least 2 psychotherapy treatment sessions

  4-months post-enrollment

• Alcohol consumption days

  % of days of alcohol consumption as measured by the Timeline Follow Back Interview

  4-months post-enrollment

• Alcohol consumption days

  % of days of alcohol consumption as measured by the Timeline Follow Back Interview

  8-months post-enrollment

• Alcohol consumption days

  % of days of alcohol consumption as measured by the Timeline Follow Back Interview

  12-months post-enrollment

• Heavy drinking days

  % of days of heavy drinking as measured by the Timeline Follow Back Interview

  4-months post-enrollment

• Heavy drinking days

  % of days of heavy drinking as measured by the Timeline Follow Back Interview

  8-months post-enrollment

• Heavy drinking days

  % of days of heavy drinking as measured by the Timeline Follow Back Interview

  12-months post-enrollment

Study Arms (6)

Arm A

ACTIVE COMPARATOR

First stage intervention: Telephone engagement Second stage intervention: Telehealth Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT program)

Behavioral: Telephone Engagement; Behavioral: MI-CBT

Arm B

ACTIVE COMPARATOR

First stage intervention: Telephone engagement Second stage intervention: Enhanced Telephone engagement

Behavioral: Telephone Engagement

Arm C

ACTIVE COMPARATOR

First stage intervention: Telephone engagement Second stage intervention: Not Applicable (NA), proceed directly to follow up

Behavioral: Telephone Engagement

Arm D

ACTIVE COMPARATOR

First stage intervention: Portal Engagement Second stage intervention: NA, proceed directly to follow up

Behavioral: Portal Engagement

Arm E

ACTIVE COMPARATOR

First stage intervention: Portal Engagement Second stage intervention: Enhanced Portal Engagement

Behavioral: Portal Engagement

Arm F

ACTIVE COMPARATOR

First stage intervention: Portal Engagement Second stage intervention: Telehealth MI-CBT program

Behavioral: Portal Engagement; Behavioral: MI-CBT

Interventions

Telephone Engagement BEHAVIORAL

Brief phone session with a study counselor.

Arm A; Arm B; Arm C

Portal Engagement BEHAVIORAL

Access to a virtual portal where participant messages with study counselors.

Arm D; Arm E; Arm F

MI-CBT BEHAVIORAL

8 one-on-one sessions done over the phone or video chat with a study counselor

Arm A; Arm F

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AUD
• past month heavy alcohol use
• internet access
• phone access
• able to provide informed consent

You may not qualify if:

• inability to speak or understand English
• conditions precluding informed consent or understanding of intervention or assessment content
• recent AUD treatment
• history of or at risk for complex alcohol withdrawal
• involvement in another ongoing study for alcohol/mental health/substance use treatment
• current cancer diagnosis/ currently receiving cancer treatment (other than skin cancers)
• PI discretion

Sponsors & Collaborators

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

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Bonar EE, Kidwell K, Chapman L, Walton MA, Zheng K, Bourque C, Manderachia D, Robinson OE, Eissa AA, Dailey SE, Dolecki F Jr, Teasdale OD, NanCoff A, Chizek EE, Tyner TS, Miller AL, Lin LA. Telehealth engagement and treatment strategies for adults living with alcohol use disorder: A sequential multiple assignment randomized trial protocol. Contemp Clin Trials. 2025 Sep;156:108003. doi: 10.1016/j.cct.2025.108003. Epub 2025 Jul 9.

  PMID: 40645371 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Erin E Bonar

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants are first randomly assigned to two interventions: either Telephone Engagement or Portal Engagement. Participants who do not meet the criteria for response at the post-test will be re-randomized into either enhanced first stage or a Telehealth MI-CBT program.

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: August 7, 2023
• Primary Completion (Estimated): June 18, 2027
• Study Completion (Estimated): June 18, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)