search
Back to results

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

Primary Purpose

Substance Use Disorders, Substance Use, Substance Dependence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Usual Care (EUC)
TeleTx intervention
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Telehealth, Cognitive behavioral therapy, Psychoeducation, Motivational interviewing, Alcohol consumption

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TeleTx intervention

Enhanced Usual Care (EUC)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 24, 2022
Last Updated
April 10, 2023
Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05410561
Brief Title
Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients
Official Title
Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Substance Use, Substance Dependence
Keywords
Telehealth, Cognitive behavioral therapy, Psychoeducation, Motivational interviewing, Alcohol consumption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TeleTx intervention
Arm Type
Experimental
Arm Description
The evidence-based manualized psychosocial program is via telehealth and uses adaptations of cognitive behavioral therapy and motivational interviewing.
Arm Title
Enhanced Usual Care (EUC)
Arm Type
Active Comparator
Arm Description
EUC will include brief psychoeducation about AUD and resources for treatment.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care (EUC)
Intervention Description
EUC will comprise one session of brief psychoeducation and referral information to alcohol use disorder (AUD) treatment.
Intervention Type
Behavioral
Intervention Name(s)
TeleTx intervention
Intervention Description
TeleTx will consist of an initial session and then 8 ~counseling sessions.
Primary Outcome Measure Information:
Title
Alcohol Use Disorder Treatment Initiation
Description
Percent of patients who initiate Alcohol Use Disorder psychotherapy treatment
Time Frame
3 months
Title
Alcohol Use Disorder Treatment Engagement
Description
Percent of patients who attend at least 2 additional Alcohol Use Disorder psychotherapy sessions
Time Frame
3 months
Title
Alcohol consumption days
Description
Percent days of alcohol use on the Timeline Follow Back interview
Time Frame
3-months
Title
Alcohol consumption days
Description
Percent days of alcohol use on the Timeline Follow Back interview
Time Frame
6-months
Title
Alcohol consumption days
Description
Percent days of alcohol use on the Timeline Follow Back interview
Time Frame
12-months
Title
Heavy drinking days
Description
Percent days heavy drinking on the Timeline Follow Back interview
Time Frame
3-months
Title
Heavy drinking days
Description
Percent days heavy drinking on the Timeline Follow Back interview
Time Frame
6-months
Title
Heavy drinking days
Description
Percent days heavy drinking on the Timeline Follow Back interview
Time Frame
12-months
Secondary Outcome Measure Information:
Title
Total Alcohol Use Disorder Psychotherapy Treatment Attendance
Description
Total number of psychotherapy sessions
Time Frame
6-months
Title
Total Alcohol Use Disorder Psychotherapy Treatment Attendance
Description
Total number of psychotherapy sessions
Time Frame
12-months
Title
Drinking Risk Levels (Based on World Health Organization Cut-Offs)
Description
Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes)
Time Frame
Baseline to 3-months
Title
Drinking Risk Levels (Based on World Health Organization Cut-Offs)
Description
Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes)
Time Frame
Baseline to 6-months
Title
Drinking Risk Levels (Based on World Health Organization Cut-Offs)
Description
Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes)
Time Frame
Baseline to 12-months
Title
World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)
Description
Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life.
Time Frame
Baseline to 3-months
Title
World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)
Description
Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life.
Time Frame
Baseline to 6-months
Title
World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)
Description
Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life.
Time Frame
Baseline to 12-months
Title
Alcohol consequences
Description
Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R
Time Frame
Baseline to 3-months
Title
Alcohol consequences
Description
Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R
Time Frame
Baseline to 6-months
Title
Alcohol consequences
Description
Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R
Time Frame
Baseline to 12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carly Brin, LMSW
Phone
734-552-6695
Email
brinca@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Mobley
Phone
734-232-0298
Email
lmobley@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Lin, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erin Bonar, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carly Brin
Email
brinca@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Allison Lin, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs