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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
104
Use of the EMOCARE software on the digital device of participant (smartphone, computer, etc.). The participant can activate and deactivate the software whenever he wishes.
Private psychiatric practice
Agen, France
RECRUITINGPrivate psychiatric pratice
Caen, France
RECRUITINGCentre Psychothérapique de Nancy
Laxou, France
NOT_YET_RECRUITINGPrivate psychiatric practice
Maxéville, France
TERMINATEDPrivate psychiatric practice
Nantes, France
RECRUITINGCentre Hospitalier Universitaire de Nantes
Nantes, France
NOT_YET_RECRUITINGPrivate psychiatric practice
Paris, France
NOT_YET_RECRUITINGPrivate psychiatric practice
Reims, France
NOT_YET_RECRUITINGCentre hospitalier Guillaume Régnier
Rennes, France
RECRUITINGPrivate psychiatric practice
Saint-Grégoire, France
RECRUITING...and 1 more locations
Change of scores EMOCARE
Absolute difference
Time frame: From baseline to 6 weeks
Change of scores PHQ-9 self-administrered
Absolute difference
Time frame: From baseline to 6 weeks
Score EMOCARE
Time frame: At baseline, at 2 weeks, at 4 weeks
Change of EMOCARE score
Time frame: From baseline to 2 weeks, from baseline to 4 weeks
Score PHQ-9 self administered
Time frame: At baseline, at 2 weeks, at 4 weeks, at 6 weeks
Change of score PHQ-9 self administered
Time frame: From baseline to 2 weeks, From baseline to 4 weeks
Score PHQ-9 administered by an investigator
Time frame: At baseline, at 6 weeks
Change of score PHQ-9 administered by an investigator
Time frame: From baseline to 6 weeks
Score MADRS administered by an investigator
Time frame: At baseline, at 6 weeks
Change of MADRS administered by an investigator
Time frame: From baseline to 6 weeks
Score BDI-II
Time frame: At baseline, at 6 weeks
Change of BDI-II
Time frame: From baseline to 6 weeks
Score BDI-II
Time frame: At baseline, at 2 weeks, at 4 weeks, at 6 weeks
Change of BDI-II
Time frame: From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks
EMOCARE operating time
Time frame: From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks
EQ-5D-5L
Time frame: At baseline, at 6 weeks
Number of patient with adverse event
Time frame: At baseline, at 2 weeks, at 3 weeks, at 4 weeks, at 6 weeks
Acceptability of medical device questionnaire
Time frame: At baseline, at 6 weeks
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