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

NCT04768920 | Active Not Recruiting

• 1 other identifier: HUM00189259
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders; Substance Use; Substance Dependence

Keywords

Telehealth; Motivational interviewing; Cognitive behavioral therapy

Outcome Measures

Primary Outcomes (2)

• Feasibility of the intervention (engagement)

  Percent (%) of participants engaging in the intervention

  8 weeks

• Tele-Tx Intervention acceptability

  Study-specific acceptability rating completed by participants. Based on Likert scale, higher scores indicate greater treatment acceptability

  8 weeks

Other Outcomes (2)

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

  baseline, 8 weeks post-baseline

• Change in Alcohol Consumption

  baseline, 8 weeks post baseline

Study Arms (1)

Teletx

EXPERIMENTAL

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).

Behavioral: MI-CBT Teletx

Interventions

MI-CBT Teletx BEHAVIORAL

Participants will first receive a 20-45 min phone or video session focused on raising participants' motivation to engage in treatment activities and psychoeducation material about substance use (i.e. "engagement session") including possible discussion about risks of substance use, value of alternative healthier activities, and the community and crisis resources pamphlet. 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)

Teletx

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Allison Lin, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 24, 2021
• Study Start: November 11, 2022
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): August 18, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)