REWIRE: Real-world Engagement With Interventional and Rejoyn Effectiveness

Part of paid clinical trials in Greenwich, Connecticut.

Sponsor
Yale University
Study ID
NCT07792252
Status
Not Yet Recruiting

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Conditions

  • Major Depressive Disorder (MDD)

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Number of patients prescribed Rejoyn [ Time Frame: From screening through enrollment, approximately 1 week ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale Greenwich Hospital Interventional Psychiatry ServicesGreenwichConnecticut06830-
Yale New Haven Hospital Interventional Psychiatry ServicesNew HavenConnecticut06519-

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Yale Greenwich Hospital Interventional Psychiatry Services· Greenwich, CTYale New Haven Hospital Interventional Psychiatry Services· New Haven, CT

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