REWIRE: Real-world Engagement With Interventional and Rejoyn Effectiveness (REWIRE)
4. september 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is only recruiting internally from among established patients and does not accept external participants.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
50
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Morgan Hardy, MD, MPH
- Telefonnummer: (203)764-9131
- E-mail: rewire.study@yale.edu
Studiesteder
-
-
Connecticut
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Greenwich, Connecticut, Forenede Stater, 06830
- Yale Greenwich Hospital Interventional Psychiatry Services
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New Haven, Connecticut, Forenede Stater, 06519
- Yale New Haven Hospital Interventional Psychiatry Services
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
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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
|
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Mean duration of app use to assess engagement
Tidsramme: up to Week 12
|
Mean duration in minutes of app use
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up to Week 12
|
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Mean number lessons completed to assess engagement
Tidsramme: up to Week 12
|
Mean number lessons completed
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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
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up to Week 12
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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).
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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
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Satisfaction Questionnaire to assess participant satisfaction.
Scores range from 1 to 5, with higher scores indicating more satisfaction.
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baseline and 12-weeks
|
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Number of clinicians that completed the Clinician Feasibility & Workflow Questionnaire
Tidsramme: Week 12
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Number of clinicians who referred patients to Rejoyn that complete the Clinician Feasibility & Workflow Questionnaire at the end of the study
|
Week 12
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Morgan Hardy, MD, MPH, Yale University
- Ledende efterforsker: Songjun W Li, MD PhD, Yale University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. marts 2027
Studieafslutning (Anslået)
1. marts 2027
Datoer for studieregistrering
Først indsendt
20. august 2026
Først indsendt, der opfyldte QC-kriterier
24. august 2026
Først opslået (Faktiske)
28. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2000042722
Plan for individuelle deltagerdata (IPD)
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