NCT05348317

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
May 2022Sep 2026

First Submitted

Initial submission to the registry

April 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

May 19, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

4.4 years

First QC Date

April 21, 2022

Last Update Submit

August 8, 2025

Conditions

Keywords

TelehealthMotivational InterviewingCognitive Behavioral TherapyRural Health

Outcome Measures

Primary Outcomes (2)

  • Feasibility of the intervention (engagement)

    Percent (%) of participants engaging in the intervention (at least 3 completed sessions)

    8 weeks

  • Acceptability of the telehealth intervention

    Study-specific acceptability rating completed by participants (% with a positive rating, higher % is better)

    2 months

Other Outcomes (2)

  • Change in substance consumption

    baseline, 8 weeks post-baseline

  • Change in frequency of substance use as reported on the Timeline Follow-Back (TLFB)

    baseline, 8 weeks post-baseline

Study Arms (1)

MI-CBT Teletx

EXPERIMENTAL

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).

Behavioral: VetReach

Interventions

VetReachBEHAVIORAL

Telehealth-delivered MI-CBT substance use disorder care model

MI-CBT Teletx

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Lewei Lin, MD

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

April 27, 2022

Study Start

May 19, 2022

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations