REWIRE: Real-world Engagement With Interventional and Rejoyn Effectiveness

NCT07792252 | Not Yet Recruiting FDA Device

• 1 other identifier: 2000042722
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (5)

• Number of patients prescribed Rejoyn

  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

  Mean number of times app was engaged

  up to Week 12

• Mean duration of app use to assess engagement

  Mean duration in minutes of app use

  up to Week 12

• Mean number lessons completed to assess engagement

  Mean number lessons completed

  up to Week 12

• Number of participants adherent to Rejoyn

  Adherence defined as completion of at least 12 of the 18 sessions

  up to Week 12

Secondary Outcomes (4)

• Change in Montgomery Asberg Depression Rating Scale (MADRS) score

  baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks

• Change in Quick Inventory of Depressive Symptomatology (QIDS) score

  baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks

• Mean mHealth Satisfaction Questionnaire score

  baseline and 12-weeks

• Number of clinicians that completed the Clinician Feasibility & Workflow Questionnaire

  Week 12

Study Arms (1)

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; Behavioral: Cognitive Behavioral Therapy (CBT) exercises

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.

Rejoyn in participants with Major Depressive Disorder

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.

Rejoyn in participants with Major Depressive Disorder

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You 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 may not qualify 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

Sponsors & Collaborators

• Yale University: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

Yale Greenwich Hospital Interventional Psychiatry Services

Greenwich, Connecticut, 06830, United States

Location

Yale New Haven Hospital Interventional Psychiatry Services

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Cognitive Behavioral Therapy; Exercise

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Morgan Hardy, MD, MPH

  Yale University

  PRINCIPAL INVESTIGATOR

• Songjun W Li, MD PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgan Hardy, MD, MPH

CONTACT

(203)764-9131; morgan.hardy@yale.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)