REWIRE: Real-world Engagement With Interventional and Rejoyn Effectiveness

N/ANot Yet RecruitingNCT07792252

Yale University50 enrolled

Overview

Rejoyn is a Prescription Digital Therapeutic (PDT) for adults with Major Depressive Disorder (MDD). This study aims to evaluate the feasibility, engagement, and clinical context of integrating Rejoyn into standard interventional workflows at the Yale New Haven Hospital Interventional Psychiatry Service (IPS). This is a non-significant risk, observational real-world evidence (RWE) study.

This study is only recruiting internally from among established patients and does not accept external participants.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Major Depressive Disorder (MDD)

Interventions

RejoynDEVICE

Rejoyn is a 510(k)-cleared Prescription Digital Therapeutic (PDT) for adults with Major Depressive Disorder (MDD) as an adjunct to clinician-managed treatment.

Cognitive Behavioral Therapy (CBT) exercisesBEHAVIORAL

Cognitive Behavioral Therapy (CBT) exercises, followed by an additional 6 weeks of access to the CBT content for additional review.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinician-confirmed diagnosis of Major Depressive Disorder * Currently being treated with an antidepressant medication * Currently receiving or initiating TMS or esketamine at YNHH IPS * For those receiving TMS, they must be able to initiate Rejoyn within the first two weeks of beginning TMS * Experiencing at least mild depressive symptoms as defined by QIDS of ≥6 * Clinician determines patient is appropriate for Rejoyn and prescribes it as part of standard care * Able to access and use a compatible smartphone * Able to provide informed consent for use of clinical data in research Exclusion Criteria: * Clinician determines Rejoyn is not suitable or safe for the patient * Significant cognitive impairment that prevents app use * Insufficient English proficiency to use Rejoyn * Concurrent participation in another interventional study that would interfere with naturalistic data

Locations (2)

Yale Greenwich Hospital Interventional Psychiatry Services

Greenwich, Connecticut, United States

Yale New Haven Hospital Interventional Psychiatry Services

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Number of patients prescribed Rejoyn

Number of patients prescribed Rejoyn out of all eligible patients in the clinic

Time frame: From screening through enrollment, approximately 1 week

Mean participant app use to assess engagement

Mean number of times app was engaged

Time frame: up to Week 12

Mean duration of app use to assess engagement

Mean duration in minutes of app use

Time frame: up to Week 12

Mean number lessons completed to assess engagement

Mean number lessons completed

Time frame: up to Week 12

Number of participants adherent to Rejoyn

Adherence defined as completion of at least 12 of the 18 sessions

Time frame: up to Week 12

Secondary Outcomes

Change in Montgomery Asberg Depression Rating Scale (MADRS) score

A 10-item rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed).

Time frame: baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks

Change in Quick Inventory of Depressive Symptomatology (QIDS) score

A 16-item self-reported rating scale designed to assess severity of depressive symptoms. Scores range from 0 to 27, with higher scores indicating greater depression.

Time frame: baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks

Mean mHealth Satisfaction Questionnaire score

Central Contacts

Morgan Hardy, MD, MPH

CONTACT

(203)764-9131 rewire.study@yale.edu

Data from ClinicalTrials.gov

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