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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmobot

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

Qualifiers

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

Treatments tested in this trial

  • EMOCARE software

Treatment groups

104 Participants
are divided into 1 treatment group

Sponsors and collaborators

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