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Not yet recruitingNCT07792252REWIREUpdated Sep 9, 2026

REWIRE: Real-world Engagement With Interventional and Rejoyn Effectiveness

An observational study in Major Depressive Disorder (MDD), sponsored by Yale University. Not yet recruiting at 2 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Yale University · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
22 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 22 studies in Depressive Disorder, Major by Yale University — 5 open to participants now, 8 under way, none of them phase 3. Depressive Disorder, Major · Yale University.

Started
2026
the only one that year
Observational
6 of 22
2 open now
Registered
22nd of 22
by date

Among the 22 studies in Depressive Disorder, Major by Yale University, this one is the only one that started in 2026, is one of 6 observational ones, and was the 22nd registered.

Depressive Disorder, Major

3,047 studies on the registry are indexed under Depressive Disorder, Major; 593 are open to participants now.

Browse Depressive Disorder, Major studies →

Open to participants now

5 of the 22 studies in Depressive Disorder, Major by Yale University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 413 Depressive Disorder, Major studies recruiting now, 93 (23%) set no upper age limit and 294 (71%) stop at 75 or younger; 55 take children under 18; 99 take healthy volunteers.

This study: 22 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the detailed description

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

03

Conditions studied

  • Major Depressive Disorder (MDD)
04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 for use of clinical data in research

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceRejoyn

    Rejoyn is a 510(k)-cleared Prescription Digital Therapeutic (PDT) for adults with Major Depressive Disorder (MDD) as an adjunct to clinician-managed treatment.

  • BehavioralCognitive Behavioral Therapy (CBT) exercises

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

06

What researchers measure

Primary outcomes

  1. Number of patients prescribed Rejoyn

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

    Time frame: From screening through enrollment, approximately 1 week

  2. Mean participant app use to assess engagement

    Mean number of times app was engaged

    Time frame: up to Week 12

  3. Mean duration of app use to assess engagement

    Mean duration in minutes of app use

    Time frame: up to Week 12

  4. Mean number lessons completed to assess engagement

    Mean number lessons completed

    Time frame: up to Week 12

  5. Number of participants adherent to Rejoyn

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

    Time frame: up to Week 12

Secondary outcomes

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

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

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

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

    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.

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

  3. Mean mHealth Satisfaction Questionnaire score

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

    Time frame: baseline and 12-weeks

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

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

    Time frame: Week 12

07

Study locations

2 sites
  • Yale Greenwich Hospital Interventional Psychiatry Services
    Greenwich, Connecticut 06830, United States
  • Yale New Haven Hospital Interventional Psychiatry Services
    New Haven, Connecticut 06519, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.

Of 121 non-industry observational studies under Depressive Disorder, Major, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 73. This study's planned 6 months is below that.

Counting every sponsor, half of 150 studies reached it within 38 months; a quarter within 21 and three quarters within 67.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2026
First posted
Aug 28, 2026
StartEst.
Sep 2026
Primary completionEst.
Mar 2027
CompletionEst.
Mar 2027
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07792252
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
Aug 28, 2026
Start date
Sep 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Morgan Hardy, MD, MPH
Contact
rewire.study@yale.edu
(203)764-9131
Morgan Hardy, MD, MPH
principal investigator · Yale University
Songjun W Li, MD PhD
principal investigator · Yale University

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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