Examining Feasibility and Acceptability of Telemedicine for Substance Use Disorder (SUD)

Not Applicable

Active, not recruiting

• Conditions: Substance Use Disorders; Substance Use; Substance Dependence
• Interventions: Behavioral: MI-CBT Teletx

• Registration Number: NCT04768920
• Lead Sponsor: University of Michigan

Brief Summary

The objective of this pilot intervention study is to iteratively refine motivational interviewing and psychosocial intervention programs delivered via telehealth (Teletx) to help improve substance use and other related outcomes in SUD patients who are not receiving SUD care. We will examine feasibility and acceptability of these pilot psychosocial programs in a total of n=50 participants. The goal is to refine the programs to improve acceptability and feasibility and collect preliminary data for a future fully powered randomized controlled trial (RCT) in the future.

In addition to study sessions, participants that are enrolled in the study will complete surveys prior to, during, and after treatment.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-24
• Study Start: 2022-11-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Outpatient care at Michigan Medicine in past year
• 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
• Have a Smart phone, tablet or another Wi-Fi or data-enabled device (e.g. with a camera)

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Exclusion Criteria

• Inability to speak or understand English
• 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 (DTs). Those who are at-risk of complicated withdrawal (e.g., seizures, DTs) require greater medical attention and will be excluded and referred to their clinician for medical management.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Teletx	MI-CBT Teletx	The evidence-based manualized psychosocial programs that will be delivered via telehealth are adaptations of cognitive behavioral therapy, motivational interviewing, and other psychosocial interventions to enhance initial and ongoing treatment engagement. TeleTx consists of up to 8 \~30-50 minute psychosocial sessions delivered via phone or videoconference platform (e.g. Zoom etc).

Primary Outcome Measures

Name	Time	Method
Tele-Tx Intervention acceptability	8 weeks	Study-specific acceptability rating completed by participants. Based on Likert scale, higher scores indicate greater treatment acceptability
Feasibility of the intervention (engagement)	8 weeks	Percent (%) of participants engaging in the intervention

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States