- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05348317
Developing a Telehealth Model to Improve Treatment Access for Rural Veterans With Substance Use Disorders (VetReach)
September 27, 2023 updated by: VA Office of Research and Development
Using Telehealth to Expand Treatment Access for Veterans With Opioid Use Disorder (CDA 18-008)
This project will pilot-test and obtain stakeholder input on a telehealth-delivered substance use disorder (SUD) care model (with initial engagement and ongoing MI-CBT treatment) with the goal of increasing treatment utilization and improving outcomes for rural and non-rural Veterans with SUDs.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Deborah A Manderachia, MSW
- Phone Number: (734) 222-7424
- Email: deborah.manderachia@va.gov
Study Contact Backup
- Name: Carly Brin, MSW
- Phone Number: (734) 769-7100
- Email: brinca@med.umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48105-2303
- Recruiting
- VA Ann Arbor Healthcare System, Ann Arbor, MI
-
Contact:
- Carly Brin, MSW
- Phone Number: (734) 769-7100
- Email: brinca@med.umich.edu
-
Contact:
- Deborah A Manderachia, MSW
- Phone Number: 734-222-7424
- Email: deborah.manderachia@va.gov
-
Principal Investigator:
- Lewei Lin, MD
-
Sub-Investigator:
- Mark A. Ilgen, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Veteran patients at the Ann Arbor VA Healthcare System
- Diagnostic and Statistical Manual of Mental Disorders (DSM-5) SUD diagnosis and/or substance use on average of 2 days a week over the past month
- Telephone access
- Able to provide informed consent
Exclusion Criteria:
- Receiving SUD psychotherapy
- Inability to speak or understand English
- Substantial mental health instability or conditions that preclude informed consent (e.g., acute psychosis, cognitive deficits) or understanding of assessment or program content
- Prior alcohol withdrawal seizures or delirium tremens
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MI-CBT Teletx
The intervention consists of an initial 30-60 min phone-delivered Engagement session that focuses on MI to help participants build self-efficacy and motivation to engage and to empower them to plan change and use Elicit-Provide-Elicit (EPE) to address treatment barriers (e.g., stigma, appeal, accessibility).
Participants will then complete up to 8 ~50 minute Teletx weekly sessions via videoconference (or phone if needed).
The intervention is highly patient-centered, by meeting and assessing patients where they are including in their unique context (i.e.
rural community), helping them identify reasons and motivations for change, and centered around their goals (e.g.
substance use reduction or abstinence).
|
Telehealth-delivered MI-CBT substance use disorder care model
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of the intervention (engagement)
Time Frame: 8 weeks
|
Percent (%) of participants engaging in the intervention (at least 3 completed sessions)
|
8 weeks
|
Acceptability of the telehealth intervention
Time Frame: 2 months
|
Study-specific acceptability rating completed by participants (% with a positive rating, higher % is better)
|
2 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in substance consumption
Time Frame: baseline, 8 weeks post-baseline
|
Substance use/consumption will be assessed using the 30-day Timeline Follow-Back (TLFB).
The TLFB will capture information on the frequency and quantity of substance use, with total consumption calculated.
|
baseline, 8 weeks post-baseline
|
Change in frequency of substance use as reported on the Timeline Follow-Back (TLFB)
Time Frame: baseline, 8 weeks post-baseline
|
Based on frequency and quantity, higher scores indicate worse outcome.
|
baseline, 8 weeks post-baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Lewei Lin, MD, VA Ann Arbor Healthcare System, Ann Arbor, MI
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 19, 2022
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Study Registration Dates
First Submitted
April 21, 2022
First Submitted That Met QC Criteria
April 21, 2022
First Posted (Actual)
April 27, 2022
Study Record Updates
Last Update Posted (Actual)
September 29, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDX 22-007
- PROJ-03672 (Other Identifier: VA Ann Arbor Healthcare System)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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