Major Depressive Disorder (MDD)
Conditions
Brief 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.
Detailed description
This study is only recruiting internally from among established patients and does not accept external participants.
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.
Sponsors
Yale University
Otsuka Pharmaceutical Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients prescribed Rejoyn | From screening through enrollment, approximately 1 week | Number of patients prescribed Rejoyn out of all eligible patients in the clinic |
| Mean participant app use to assess engagement | up to Week 12 | Mean number of times app was engaged |
| Mean duration of app use to assess engagement | up to Week 12 | Mean duration in minutes of app use |
| Mean number lessons completed to assess engagement | up to Week 12 | Mean number lessons completed |
| Number of participants adherent to Rejoyn | up to Week 12 | Adherence defined as completion of at least 12 of the 18 sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Montgomery Asberg Depression Rating Scale (MADRS) score | 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). |
| Change in Quick Inventory of Depressive Symptomatology (QIDS) score | 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. |
| Mean mHealth Satisfaction Questionnaire score | baseline and 12-weeks | Satisfaction Questionnaire to assess participant satisfaction. Scores range from 1 to 5, with higher scores indicating more satisfaction. |
| Number of clinicians that completed the Clinician Feasibility & Workflow Questionnaire | Week 12 | Number of clinicians who referred patients to Rejoyn that complete the Clinician Feasibility \& Workflow Questionnaire at the end of the study |
Countries
United States
Contacts
CONTACTMorgan Hardy, MD, MPH
PRINCIPAL_INVESTIGATORMorgan Hardy, MD, MPH
Yale University
PRINCIPAL_INVESTIGATORSongjun W Li, MD PhD
Yale University
Outcome results
None listed