About this trial
The aim of this clinical investigation is to find out whether the EMOCARE emotional monitoring software provides consistent results compared with the tools available for assessing the emotional state of patients suffering from mild to moderately severe depressive episod. It will also provide information on how patients feel about the use of passive monitoring software (without the active involvement of patient). The main questions it aims to answer are as follows:
Does EMOCARE provide consistent results compared with tools already used in current practice? What are the medical problems encountered by participants when using EMOCARE?
The researchers will compare EMCOCARE to various questionnaires usually used in the management of patients suffering from depression (PHQ-9, MADRS, GAD-7, BDI-II, EQ-5D-5L).
Participants who agree to take part in the study, during a selection visit, will be able to:
1. Install the software on a digital interface (smartphone, computer, etc.) and activate or deactivate it whenever they wish during the 6-week follow-up period. 2. Attend 2 scheduled appointments at the centre (a first appointment then a second 6 weeks later) to complete a series of questionnaires, being questioned by the doctor, and fill in other questionnaires on their own. 3. At home, answer questionnaires independently, 2 weeks and 4 weeks after the first appointment. 4. Receive a telephone call from the doctor 3 weeks after the first appointment to find out how the participants are feeling. 5. Keep a diary with the symptoms they have experienced, any medical consultations they have made, or changes in drug treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient of both sexes aged 18 or over.
Outpatient with unipolar depression (regardless of the time of the episode) (major depressive disorder).
Patient with an episode of major depression supported by PHQ-9 score greater than or equal to 5.
Patient with an episode of major depression supported by MADRS score greater than or equal to 7.
Disqualifiers
Patient treated with antipsychotic drugs.
Patient with an unstable pathology that could interfere with the study.
Patient unable to communicate or cooperate with the investigator due to a low mental level, language difficulties or impaired cerebral function.
Patient with an active suicidal tendency or patient who has had a suicidal episode in the last 6 months
Trial design
Single group
Treatments tested in this trial
EMOCARE software
DeviceUse of the EMOCARE software on the digital device of participant (smartphone, computer, etc.). The participant can activate and deactivate the software whenever he wishes.
Treatment groups
Trial outcomes
Primary outcomes
Change of scores EMOCARE
Absolute difference
Change of scores PHQ-9 self-administrered
Absolute difference
Secondary outcomes
Score EMOCARE
Change of EMOCARE score
Score PHQ-9 self administered
Change of score PHQ-9 self administered
Sponsors and contacts
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Emobot
Lead sponsor
Nantes University Hospital
Collaborator
Private psychiatric practice, Saint-Nazaire
Collaborator
Groupement Hospitalier Paul Guiraud, Villejuif
Collaborator
Centre Hospitalier Guillaume Régnier, RENNES
Collaborator
Centre de Psychothérapie Nancéen, Laxou
Collaborator
Rumb
Collaborator
Private psychiatric pratice, Agen
Collaborator
Private psychiatric pratice, Caen
Collaborator