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REWIRE: Real-world Engagement With Interventional and Rejoyn Effectiveness
Sponsor: Yale University
Summary
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.
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
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2026-09
Completion Date
2027-03
Last Updated
2026-09-09
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (2)
Yale Greenwich Hospital Interventional Psychiatry Services
Greenwich, Connecticut, United States
Yale New Haven Hospital Interventional Psychiatry Services
New Haven, Connecticut, United States