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

NCT ID: NCT05594238

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-07

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm F

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

Group Type ACTIVE_COMPARATOR

Portal Engagement

Intervention Type BEHAVIORAL

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

MI-CBT

Intervention Type BEHAVIORAL

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

Arm E

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

Group Type ACTIVE_COMPARATOR

Portal Engagement

Intervention Type BEHAVIORAL

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

Arm A

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

Group Type ACTIVE_COMPARATOR

Telephone Engagement

Intervention Type BEHAVIORAL

Brief phone session with a study counselor.

MI-CBT

Intervention Type BEHAVIORAL

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

Arm B

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

Group Type ACTIVE_COMPARATOR

Telephone Engagement

Intervention Type BEHAVIORAL

Brief phone session with a study counselor.

Arm C

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

Group Type ACTIVE_COMPARATOR

Telephone Engagement

Intervention Type BEHAVIORAL

Brief phone session with a study counselor.

Arm D

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

Group Type ACTIVE_COMPARATOR

Portal Engagement

Intervention Type BEHAVIORAL

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

Interventions

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Telephone Engagement

Brief phone session with a study counselor.

Intervention Type BEHAVIORAL

Portal Engagement

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

Intervention Type BEHAVIORAL

MI-CBT

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Erin Bonar

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erin E Bonar

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Carly Brin

Role: CONTACT

7344968154

Carly Brin

Role: CONTACT

Facility Contacts

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Carly Brin

Role: primary

734-496-8154

References

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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.

Reference Type DERIVED
PMID: 40645371 (View on PubMed)

Other Identifiers

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R01AA029808

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00210546

Identifier Type: -

Identifier Source: org_study_id