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REWIRE: Real-world Engagement With Interventional and Rejoyn Effectiveness

A Prospective Observational Real-World Evidence Study of a 510(k)-Cleared Prescription Digital Therapeutic in Patients Receiving Interventional Treatment for Major Depressive Disorder

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how Rejoyn, a prescription digital treatment for adults with major depression, fits into usual care at Yale New Haven Hospital’s Interventional Psychiatry Service. It follows people taking antidepressants who are also getting or starting TMS or esketamine, and looks at how they use Rejoyn.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A clinician has confirmed that you have major depression.
  • You are taking an antidepressant medicine.
  • You are getting or starting TMS (a treatment using magnetic pulses) or esketamine (a medicine for depression) at Yale New Haven Hospital’s Interventional Psychiatry Service.
  • If you are getting TMS, you can start Rejoyn within the first two weeks of TMS.
  • You have at least mild depression symptoms, with a score of 6 or higher on the QIDS depression symptom scale.
  • Your clinician decides Rejoyn is right for you and prescribes it as part of your usual care.
  • You can access and use a smartphone that works with Rejoyn.
  • You can give informed consent, meaning you understand and agree to let researchers use your health care data.

Who can't join

  • Your clinician decides Rejoyn is not right or safe for you.
  • You have serious problems with thinking or memory that prevent you from using the app.
  • You cannot understand enough English to use Rejoyn.
  • You are in another study testing a treatment that would interfere with this study’s data on usual care.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (2)

CT