Comprehensive CBT (Cognitive Behavioral Therapy) Via reSET App

NCT ID: NCT03826966

Last Updated: 2020-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-04

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Addiction Opioid-use Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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).

Interventions

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reSET

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role collaborator

Research Foundation for Mental Hygiene, Inc.

OTHER

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sarah Kawasaki

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pennsylvania Psychiatric Institute, Opioid Treatment Program

Harrisburg, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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00009931

Identifier Type: -

Identifier Source: org_study_id

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