Back to results

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

Primary Purpose

Substance Use Disorders, Substance Use, Substance Dependence

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MI-CBT Teletx

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Telehealth, Motivational interviewing, Cognitive behavioral therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Teletx

Arm Description

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).

Outcomes

Primary Outcome Measures

Feasibility of the intervention (engagement)

Percent (%) of participants engaging in the intervention

Tele-Tx Intervention acceptability

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04768920

First Posted

February 19, 2021

Last Updated

June 27, 2023

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT04768920

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 11, 2022 (Actual)

Primary Completion Date

February 28, 2026 (Anticipated)

Study Completion Date

February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Use Disorders, Substance Use, Substance Dependence

Keywords

Telehealth, Motivational interviewing, Cognitive behavioral therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Teletx

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

MI-CBT Teletx

Intervention Description

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)

Primary Outcome Measure Information:

Title

Feasibility of the intervention (engagement)

Description

Percent (%) of participants engaging in the intervention

Time Frame

8 weeks

Title

Tele-Tx Intervention acceptability

Description

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

Time Frame

8 weeks

Other Pre-specified Outcome Measures:

Title

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

Description

Based on frequency and quantity, higher scores indicate worse outcome.

Time Frame

baseline, 8 weeks post-baseline

Title

Change in Alcohol Consumption

Description

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.

Time Frame

baseline, 8 weeks post baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allison Lin, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs