reSET-O RCT (Randomized Controlled Trial)

Not Applicable

Completed

Conditions: Opioid-use Disorder

Interventions: Device: reSET-O app

Registration Number: NCT04129580

Lead Sponsor: Milton S. Hershey Medical Center

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

Inclusion Criteria

18 years of age or older
Diagnosis of opioid use disorder (OUD) as determined through routine clinical care
Recently starting outpatient treatment for OUD within the Penn State Health Hub and Spoke System of Care
Initiating MAT with buprenorphine-naloxone (suboxone), buprenorphine (Subutex), or methadone. Since buprenorphine (Subutex) is an FDA approved MAT for pregnant women with OUD, pregnant women are eligible to participate in the research study, assuming they meet all other eligibility requirements.
Prison inmates are eligible to participate in the study
Ability to read, write, and comprehend English

Exclusion Criteria

Initiating maintenance treatment that does not include MAT or switching to a maintenance treatment that does not include MAT (i.e.: detoxification and counseling treatment only without MAT).
Planning an outpatient detoxification
Judged by the evaluating physician or allied clinician to need a higher level of care (i.e.: residential or inpatient treatment)
Less than 18 years of age
Unable to read, write, and comprehend English

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment-As-Usual (TAU) + reSET-O	reSET-O app	Participants randomly assigned to this arm will receive their TAU alongside the use of the app, reSET-O.

Primary Outcome Measures

Name	Time	Method
Retention in Treatment on MAT for 6 Months After Enrolling in the Study	6 months	reSET-O is a mobile app designed to provide extended cognitive behavioral therapy for patients initiating medication assisted treatment (MAT) for opioid use disorder (OUD). 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.

Secondary Outcome Measures

Name	Time	Method
Opioid and Other Substance Abuse as Assessed Through Biological Specimen	6 months	Part of this study is looking at the effect of reSET-O on substance use. This will be measured by collecting urine drug screens to assess drug use (if any) at each research appointment. The number of endorsed drugs used (as indicated by a positive urine drug screen) will be counted and recorded for each research visit.
Overall Mental Health Symptoms Related to Depression and Anxiety as Assessed by the K-10	6 months	Part of this study is looking at the effect of reSET-O on 6 month adherence and mediation of improvements in quality of life outcomes such as overall mental health symptoms as measured by participant self-report on the Kessler 10 (K-10). A score of one indicates that an individual experiences symptoms or issues "None of the time," whereas a score of five indicates that an individual experiences symptoms or issues "All of time." The scores are summed and total amounts will fall in one of four categories: Score under 20 = likely to be well; Score 20-24 = likely to have a mild mental disorder; Score 25-29 = likely to have a moderate mental disorder; and Score 30 or more = likely to have a severe mental disorder. Baseline measurements were assessed and compared with results at 24 weeks in each arm. A negative number indicates improvement over the course of the study.
Mental Health Symptoms Specific to Depression as Assessed by the PHQ-9	6 months	Part of this study is looking at the effect of reSET-O on 6 month adherence and mediation of improvements in quality of life outcomes such as mental health specific to depression as measured by the participant self-report on the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9 item questionnaire that assesses depressive symptoms or issues using a likert scale from "0 to 3;" 0 indicating no symptoms or issues and 3 indicating symptoms or issues occurring nearly every day. Scores are summed to calculate a total score. Scores 1-4 indicated minimal depression; scores 5-9 indicate mild depression; scores 10-14 indicate moderate depression; scores 15-19 indicated moderately severe depression; and scores 20-27 indicate severe depression. Baseline measurements were assessed and compared with results at 24 weeks in each arm. A negative number indicates improvement over the course of the study.
Opioid and Other Substance Abuse as Assessed Through Participant Self-report	6 months	Part of this study is looking at the effect of reSET-o on substance use. This will be measured by participant self-report on the Timeline Follow Back Questionnaire (TLFB). The TLFB is a self-report measure that gages the participant's memory by using a calendar to assess drug use within a specific period of time. The number of endorsed drugs used (as indicated by the participant) will be counted and recorded for each research visit.
Mental Health Symptoms Related to PTSD as Assessed by the PCL-C	6 months	Part of this study is looking at the effect of reSET-O on 6 month adherence and mediation of improvements in quality of life outcomes such as mental health specific to post-traumatic stress disorder as measured by the participant self-report on the abbreviated PTSD Checklist-Civilian Version (PCL-C). The PCL-C is a 17 item questionnaire that assesses PTSD symptoms on a likert scale from one to five (one = no symptoms or issues; five = extreme symptoms or issues). The scores are summed and a score of 30 or more indicates clinical PTSD symptoms. Baseline measurements were assessed and compared with results at 24 weeks in each arm. A negative number indicates improvement over the course of the study.