REWIRE: Real-world Engagement With Interventional and Rejoyn Effectiveness (REWIRE)
4. september 2026 oppdatert av: Yale University
A Prospective Observational Real-World Evidence Study of a 510(k)-Cleared Prescription Digital Therapeutic in Patients Receiving Interventional Treatment for Major Depressive Disorder
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study is only recruiting internally from among established patients and does not accept external participants.
Studietype
Observasjonsmessig
Registrering (Antatt)
50
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Morgan Hardy, MD, MPH
- Telefonnummer: (203)764-9131
- E-post: rewire.study@yale.edu
Studiesteder
-
-
Connecticut
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Greenwich, Connecticut, Forente stater, 06830
- Yale Greenwich Hospital Interventional Psychiatry Services
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New Haven, Connecticut, Forente stater, 06519
- Yale New Haven Hospital Interventional Psychiatry Services
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Adults diagnosed with MDD who are receiving intranasal esketamine or TMS.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
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, followed by an additional 6 weeks of access to the CBT content for additional review.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of patients prescribed Rejoyn
Tidsramme: From screening through enrollment, approximately 1 week
|
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
Tidsramme: up to Week 12
|
Mean number of times app was engaged
|
up to Week 12
|
|
Mean duration of app use to assess engagement
Tidsramme: up to Week 12
|
Mean duration in minutes of app use
|
up to Week 12
|
|
Mean number lessons completed to assess engagement
Tidsramme: up to Week 12
|
Mean number lessons completed
|
up to Week 12
|
|
Number of participants adherent to Rejoyn
Tidsramme: up to Week 12
|
Adherence defined as completion of at least 12 of the 18 sessions
|
up to Week 12
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Montgomery Asberg Depression Rating Scale (MADRS) score
Tidsramme: 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).
|
baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
|
|
Change in Quick Inventory of Depressive Symptomatology (QIDS) score
Tidsramme: 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.
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baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
|
|
Mean mHealth Satisfaction Questionnaire score
Tidsramme: baseline and 12-weeks
|
Satisfaction Questionnaire to assess participant satisfaction.
Scores range from 1 to 5, with higher scores indicating more satisfaction.
|
baseline and 12-weeks
|
|
Number of clinicians that completed the Clinician Feasibility & Workflow Questionnaire
Tidsramme: Week 12
|
Number of clinicians who referred patients to Rejoyn that complete the Clinician Feasibility & Workflow Questionnaire at the end of the study
|
Week 12
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Morgan Hardy, MD, MPH, Yale University
- Hovedetterforsker: Songjun W Li, MD PhD, Yale University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. mars 2027
Studiet fullført (Antatt)
1. mars 2027
Datoer for studieregistrering
Først innsendt
20. august 2026
Først innsendt som oppfylte QC-kriteriene
24. august 2026
Først lagt ut (Faktiske)
28. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2000042722
Plan for individuelle deltakerdata (IPD)
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NEI
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