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Researchers are evaluating EmoDTx, a digital tool designed to monitor mood in adults diagnosed with unipolar depression. This prospective, multicenter observational study uses a single-arm design to compare mood scores obtained through the EmoDTx application, which analyzes facial expressions, with standard depression questionnaires like MADRS, PHQ-9, BDI-II, HAMD-17, and QIDS-SR16. The study also explores patient experiences with passive monitoring software and how feedback from the app may support their care. Participants will install the EmoDTx software on a digital device such as a smartphone or computer and can turn it on or off during the 8-week follow-up period. They will attend three scheduled visits at the study center: the initial visit, a 4-week follow-up, and a final visit at 8 weeks. At these visits, they will complete various questionnaires and have discussions with their doctor. Additionally, participants will complete questionnaires independently at home at 2 and 6 weeks after the first appointment. The app's feedback feature will be disabled during the first 4 weeks and activated during the last 4 weeks of the study. A smaller ancillary study will involve video-recorded clinical interviews for some participants at baseline and 4 weeks. Throughout the study, researchers will measure changes in depression scores from baseline to 4 weeks using EmoDTx and investigator-administered MADRS. Participants' emotional states and responses to the app will be monitored through questionnaires and clinical interviews. The study includes safety monitoring and aims to understand how digital mood monitoring may aid in managing unipolar depression over the 8-week period.

Age: 18Years +All Genders
2 locations
Clinical trials in Changé | DecenTrialz