Comprehensive CBT (Cognitive Behavioral Therapy) Via reSET App

NCT03826966 | Completed DMC

• 1 other identifier: 00009931
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to find out whether an app based cognitive behavior therapy called reSET improves the adherence to and outcome of buprenorphine treatment for opioid use disorder (OUD) in the setting of a Hub and Spoke implementation system.

Conditions

Addiction; Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Retention in treatment on MAT for 6 months after enrolling in the study

  ReSET is a mobile app designed to provide extended cognitive behavioral therapy for patients initiating medication assisted treatment (MAT) for opioid use disorder (OUD). This pilot trial is evaluating the acceptability and feasibility of the app, reSET. The first outcome being measure is treatment retention. We want to examine if participants enrolled in the study will maintain on MAT for 6 months after enrollment. This will be evaluated based on the number of appointments attended by the research participants. Data mining through our systems electronic medical record (EMR) will be conducted in order to count the number of attended appointments for study participants to gauge their treatment retention.

  6 months

Secondary Outcomes (12)

• Opioid and other substance abuse as assessed through biological specimen

  6 months

• Opioid and other substance abuse as assessed through participant self-report

  6 months

• Cravings to use drugs as assessed by the reSET app

  6 months

• Overall mental health symptoms related to depression and anxiety as assessed by the K-10

  6 months

• Mental health symptoms specific to depression as assessed by the PHQ-9

  6 months

Interventions

reSET DEVICE

reSET is a mobile app created by Pear Therapeutics, Inc., which has previously been approved by the FDA.

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Starting outpatient treatment for OUD within the PACMAT Hub and Spoke system (either the Hub or one of the Spokes)
• Planning maintenance treatment with buprenorphine
• Willing to participate in the study
• Can read, write and comprehend English

You may not qualify if:

• Planning an outpatient detoxification, or treatment other than buprenorphine maintenance (e.g. methadone maintenance, Vivitrol, or counseling with no medication)
• Judged by the evaluating physician or allied clinician to need a higher level of care (e.g. residential or inpatient treatment)
• Unwilling to participate in the study
• Under the age of 18
• Unable to read, write and comprehend English

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Columbia University: collaborator
• Research Foundation for Mental Hygiene, Inc.: collaborator

Study Sites (1)

Pennsylvania Psychiatric Institute, Opioid Treatment Program

Harrisburg, Pennsylvania, 17110, United States

Location

MeSH Terms

Conditions

Behavior, Addictive; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: N/A at this time. This trial is a pilot study seeking an N of 15 participants. All participants will be assigned the "treatment," which is accessing an mobile app, re-SET, for cognitive behavioral therapy extension that is to be used with MAT (Buprenorphine only at this time).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: February 1, 2019
• Study Start: March 4, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

US (1)