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

Study Overview
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Brief Summary
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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.

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

Conditions
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Substance Use Disorders, Substance Use, Substance Dependence

Intervention / Treatment
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* Behavioral: MI-CBT Teletx


Participation Criteria
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Eligibility Criteria
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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) 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teletx<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telehealth, Motivational interviewing, Cognitive behavioral therapy