Comparing EMOCARE Emotional Monitoring Software with Standard Questionnaires for Adults with Mild to Severe Major Depressive Disorder

What this Trial Is About

Researchers are evaluating whether the EMOCARE emotional monitoring software provides consistent results compared to standard questionnaires used to assess emotional states in patients with mild to moderately severe depressive episodes. This study aims to understand how well EMOCARE matches tools like PHQ-9, MADRS, GAD-7, BDI-II, and EQ-5D-5L, and to learn about any medical issues participants may experience when using this passive monitoring software. The study focuses on outpatients with major depressive disorder who use digital devices regularly. Participants will install the EMOCARE software on a smartphone, computer, or similar device and can activate or deactivate it during a six-week follow-up period. They will attend two scheduled visits at the centerone at the start and one six weeks laterto complete questionnaires and be interviewed by a doctor. Additionally, participants will complete questionnaires independently at home two and four weeks after the first appointment. A phone call from the doctor will take place three weeks after the initial visit to check on how participants are feeling. Participants will also keep a diary of symptoms, medical consultations, and any medication changes. Throughout the study, researchers will collect and compare scores from EMOCARE and various questionnaires at multiple time points, including baseline, two, four, and six weeks. They will monitor the acceptability of the device, adverse events, and changes in depression severity. The main outcomes measured are changes in EMOCARE scores and PHQ-9 scores from baseline to six weeks. The total participation duration is six weeks, with regular monitoring and assessments to understand emotional states and device use.

Evaluation of the Concordance Between Measures Obtained by a Medical Device for Emotional Monitoring (EMOCARE) and the Patient Health Questionnaire (PHQ-9) Score in Patients With Mild to Severe Depressive Episode