- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04768920
Examining Feasibility and Acceptability of Telemedicine for Substance Use Disorder (SUD)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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).
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of the intervention (engagement)
Time Frame: 8 weeks
|
Percent (%) of participants engaging in the intervention
|
8 weeks
|
|
Tele-Tx Intervention acceptability
Time Frame: 8 weeks
|
Study-specific acceptability rating completed by participants.
Based on Likert scale, higher scores indicate greater treatment acceptability
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in frequency of substance use as reported on the Timeline Follow-Back (TLFB)
Time Frame: baseline, 8 weeks post-baseline
|
Based on frequency and quantity, higher scores indicate worse outcome.
|
baseline, 8 weeks post-baseline
|
|
Change in Alcohol Consumption
Time Frame: baseline, 8 weeks post baseline
|
Alcohol consumption will be assessed using the 30-day Timeline Follow-Back (TLFB).
The TLFB will capture information on the frequency and quantity of alcohol use including binge drinking, with total consumption calculated.
|
baseline, 8 weeks post baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Allison Lin, MD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00189259
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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