Testing EmoDTx, a Digital Tool for Monitoring Mood in Adults With Unipolar Depression Comparing EmoDTx With Standard Depression Questionnaires in an Observational Study

What this Trial Is About

Researchers are evaluating the EmoDTx, a digital mood-monitoring application, in adult patients with unipolar depression. This prospective, multicenter, observational study aims to validate EmoDTx by comparing its mood scores, based on facial expression analysis, with standard depression questionnaires such as MADRS, PHQ-9, BDI-II, HAMD-17, and QIDS-SR16. The study also explores patient opinions on passive monitoring software and how feedback from the app may support their care. Participants will install EmoDTx on their smartphone or computer and can choose to activate or deactivate the app during the 8-week follow-up. They will attend three appointments at the study center at the start, 4 weeks, and 8 weeks, completing questionnaires and clinical interviews. The app feedback will be off for the first 4 weeks and then turned on for the last 4 weeks. A smaller group of 16 patients will also participate in a related video-recorded clinical interview study. During the study, participants complete questionnaires in person and at home at set intervals 2, 4, 6, and 8 weeks. Researchers will measure changes in EmoDTx scores compared to standard questionnaires and assess the apps ability to detect mood changes earlier. They will also evaluate patient acceptance of the device. The total participation duration is 8 weeks, with mood monitoring and clinical assessments throughout this period.

Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients Suffering From Unipolar Depression