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NCT Number: NCT07792252

REWIRE: Real-world Engagement With Interventional and Rejoyn Effectiveness

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.

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Key information

Conditions

Major Depressive Disorder (MDD) Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale Greenwich Hospital Interventional Psychiatry Services, Greenwich, Connecticut, United States

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About this study

This study is only recruiting internally from among established patients and does not accept external participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of patients prescribed Rejoyn

    Time frame: From screening through enrollment, approximately 1 week

    Number of patients prescribed Rejoyn out of all eligible patients in the clinic

  2. Mean participant app use to assess engagement

    Time frame: up to Week 12

    Mean number of times app was engaged

  3. Mean duration of app use to assess engagement

    Time frame: up to Week 12

    Mean duration in minutes of app use

  4. Mean number lessons completed to assess engagement

    Time frame: up to Week 12

    Mean number lessons completed

  5. Number of participants adherent to Rejoyn

    Time frame: up to Week 12

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

Secondary outcomes

  1. Change in Montgomery Asberg Depression Rating Scale (MADRS) score

    Time frame: baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks

    A 10-item rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed).

  2. Change in Quick Inventory of Depressive Symptomatology (QIDS) score

    Time frame: baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks

    A 16-item self-reported rating scale designed to assess severity of depressive symptoms. Scores range from 0 to 27, with higher scores indicating greater depression.

  3. Mean mHealth Satisfaction Questionnaire score

    Time frame: baseline and 12-weeks

    Satisfaction Questionnaire to assess participant satisfaction. Scores range from 1 to 5, with higher scores indicating more satisfaction.

  4. Number of clinicians that completed the Clinician Feasibility & Workflow Questionnaire

    Time frame: Week 12

    Number of clinicians who referred patients to Rejoyn that complete the Clinician Feasibility & Workflow Questionnaire at the end of the study

Study contacts

Contact information is provided by the study sponsor or research team.

Morgan Hardy, MD, MPH

CONTACT

[email protected]

(203)764-9131

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study 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

Acronym: REWIRE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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