NCT04129580

reSET-O RCT (Randomized Controlled Trial)

A Randomized Clinical Trial of Comprehensive Cognitive Behavioral Therapy (CBT) Via reSET-O for a Hub and Spoke Medication Assisted Treatment (MAT) System of Care.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial research study will be evaluating an app, reSET-O, owned by Pear Therapeutics, Inc., to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment.

Detailed description

This randomized controlled trial research study will enroll 200 subjects, where half will be randomly assigned to treatment as usual (TAU) and the app, reSET-O (n = 100), and half will be assigned to TAU only (n = 100), in order to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment. All subjects will participate in the study for a total of six months, and all subjects will attend five research appointments across the six months. Participants assigned to TAU + reSET-O will be expected to engage with the app, reSET-O, for the full six months. The app works as an extension of cognitive behavioral therapy as it provides psychoeducation related to opioid dependence and use, and is designed as an adjunctive treatment with medication assisted treatment for opioid use disorder.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
DEVICE	reSET-O app	The reSET-O app, owned by Pear Therapeutics, Inc., is designed to work as cognitive behavioral therapy, adjunctive to medication assisted treatment, for opioid use disorder. The app provides psychoeducation related to opioid use and dependence, coping skills, and skills to avoid relapse,

Timeline

• Start date: 2020-09-15
• Primary completion: 2023-07-14
• Completion: 2024-09-19
• First posted: 2019-10-17
• Last updated: 2024-11-20
• Results posted: 2024-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study