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Clinical Trials/NCT05594238
NCT05594238
Active, not recruiting
Not Applicable

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

University of Michigan2 sites in 1 country362 target enrollmentAugust 7, 2023

Overview

Phase
Not Applicable
Intervention
Portal Engagement
Conditions
Alcohol Use Disorder
Sponsor
University of Michigan
Enrollment
362
Locations
2
Primary Endpoint
Heavy drinking days
Status
Active, not recruiting
Last Updated
19 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 7, 2023
End Date
June 18, 2027
Last Updated
19 days ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Erin Bonar

Associate Professor

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • 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

Arms & Interventions

Arm F

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

Intervention: Portal Engagement

Arm F

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

Intervention: MI-CBT

Arm A

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

Intervention: Telephone Engagement

Arm A

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

Intervention: MI-CBT

Arm B

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

Intervention: Telephone Engagement

Arm C

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

Intervention: Telephone Engagement

Arm D

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

Intervention: Portal Engagement

Arm E

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

Intervention: Portal Engagement

Outcomes

Primary Outcomes

Heavy drinking days

Time Frame: 12-months post-enrollment

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

AUD Treatment Initiation

Time Frame: 4-months post-enrollment

% of patients who initiate psychotherapy treatment

AUD Treatment Engagement

Time Frame: 4-months post-enrollment

% of patients who attend at least 2 psychotherapy treatment sessions

Alcohol consumption days

Time Frame: 12-months post-enrollment

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

Alcohol consumption days

Time Frame: 4-months post-enrollment

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

Alcohol consumption days

Time Frame: 8-months post-enrollment

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

Heavy drinking days

Time Frame: 4-months post-enrollment

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

Heavy drinking days

Time Frame: 8-months post-enrollment

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

Study Sites (2)

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