REWIRE: Real-world Engagement With Interventional and Rejoyn Effectiveness (REWIRE)

September 4, 2026 updated by: Yale University

A Prospective Observational Real-World Evidence Study of a 510(k)-Cleared Prescription Digital Therapeutic in Patients Receiving Interventional Treatment for Major Depressive Disorder

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • Greenwich, Connecticut, United States, 06830
        • Yale Greenwich Hospital Interventional Psychiatry Services
      • New Haven, Connecticut, United States, 06519
        • Yale New Haven Hospital Interventional Psychiatry Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults diagnosed with MDD who are receiving intranasal esketamine or TMS.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rejoyn in participants with Major Depressive Disorder
Rejoyn is a 510(k)-cleared Prescription Digital Therapeutic (PDT) for adults with Major Depressive Disorder (MDD) as an adjunct to clinician-managed treatment. The Rejoyn program includes 6 weeks of active Emotional Faces Memory Task (EFMT) training and Cognitive Behavioral Therapy (CBT) exercises, followed by an additional 6 weeks of access to the CBT content for additional review.
Device: Rejoyn
Rejoyn is a 510(k)-cleared Prescription Digital Therapeutic (PDT) for adults with Major Depressive Disorder (MDD) as an adjunct to clinician-managed treatment.
Behavioral: Cognitive Behavioral Therapy (CBT) exercises
Cognitive Behavioral Therapy (CBT) exercises, followed by an additional 6 weeks of access to the CBT content for additional review.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients prescribed Rejoyn
Time Frame: From screening through enrollment, approximately 1 week
Number of patients prescribed Rejoyn out of all eligible patients in the clinic
From screening through enrollment, approximately 1 week
Mean participant app use to assess engagement
Time Frame: up to Week 12
Mean number of times app was engaged
up to Week 12
Mean duration of app use to assess engagement
Time Frame: up to Week 12
Mean duration in minutes of app use
up to Week 12
Mean number lessons completed to assess engagement
Time Frame: up to Week 12
Mean number lessons completed
up to Week 12
Number of participants adherent to Rejoyn
Time Frame: up to Week 12
Adherence defined as completion of at least 12 of the 18 sessions
up to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Montgomery Asberg Depression Rating Scale (MADRS) score
Time Frame: baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
A 10-item rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed).
baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
Change in Quick Inventory of Depressive Symptomatology (QIDS) score
Time Frame: baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
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.
baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
Mean mHealth Satisfaction Questionnaire score
Time Frame: baseline and 12-weeks
Satisfaction Questionnaire to assess participant satisfaction. Scores range from 1 to 5, with higher scores indicating more satisfaction.
baseline and 12-weeks
Number of clinicians that completed the Clinician Feasibility & Workflow Questionnaire
Time Frame: Week 12
Number of clinicians who referred patients to Rejoyn that complete the Clinician Feasibility & Workflow Questionnaire at the end of the study
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Morgan Hardy, MD, MPH, Yale University
  • Principal Investigator: Songjun W Li, MD PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

August 20, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 28, 2026

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000042722

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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