What this study is
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.
What's being tested
- Rejoyn
Intervention · DEVICE
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) exercises
Intervention · BEHAVIORAL
Cognitive Behavioral Therapy (CBT) exercises, followed by an additional 6 weeks of access to the CBT content for additional review.
Study details
- Official title
- A Prospective Observational Real-World Evidence Study of a 510(k)-Cleared Prescription Digital Therapeutic in Patients Receiving Interventional Treatment for Major Depressive Disorder
- Sponsor
- Yale University
- Conditions
- Major Depressive Disorder (MDD)
- Enrolling
- 50 people
- Starts
- 2026-09
- Est. completion
- 2027-03
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 22 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openYale Greenwich Hospital Interventional Psychiatry Services
Greenwich, Connecticut, United States
Yale New Haven Hospital Interventional Psychiatry Services
New Haven, Connecticut, United States
Study team
Sponsor
Yale University
Study ID 2000042722
Principal investigator
Morgan Hardy, MD, MPH
Yale University
Principal investigator
Songjun W Li, MD PhD
Yale University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.