REWIRE: Real-world Engagement With Interventional and Rejoyn Effectiveness

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.

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