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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05348317
Other study ID # CDX 22-007
Secondary ID PROJ-03672
Status Recruiting
Phase N/A
First received
Last updated
Start date May 19, 2022
Est. completion date September 30, 2026

Study information

Verified date September 2023
Source VA Office of Research and Development
Contact Deborah A Manderachia, MSW
Phone (734) 222-7424
Email deborah.manderachia@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 30, 2026
Est. primary completion date September 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

Behavioral:
VetReach
Telehealth-delivered MI-CBT substance use disorder care model

Locations

Country Name City State
United States VA Ann Arbor Healthcare System, Ann Arbor, MI Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
VA Office of Research and Development VA Ann Arbor Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in substance consumption 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
Other Change in frequency of substance use as reported on the Timeline Follow-Back (TLFB) Based on frequency and quantity, higher scores indicate worse outcome. baseline, 8 weeks post-baseline
Primary Feasibility of the intervention (engagement) Percent (%) of participants engaging in the intervention (at least 3 completed sessions) 8 weeks
Primary Acceptability of the telehealth intervention Study-specific acceptability rating completed by participants (% with a positive rating, higher % is better) 2 months
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