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 Moderate Depressive Episode

Last updated: March 5, 2025
Sponsor: Emobot
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

EMOCARE software

Clinical Study ID

NCT06601140
EB-EMC1-2024
2024-A01487-40
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Patient of both sexes aged 18 or over.

  • Outpatient with unipolar depression (regardless of the time of the episode) (majordepressive disorder).

  • Patient with an episode of major depression supported by PHQ-9 score greater than orequal to 5 and strictly less than 20.

  • Patient with an episode of major depression supported by MADRS score greater than orequal to 7 and strictly less than 35.

  • Patient accustomed to regular use of a smartphone and/or computer

  • Patient who, in the opinion of the investigator, will comply with the requirementsof the protocol.

  • Patient affiliated to a social security scheme or beneficiary of such a scheme.

  • Patient who has received full information about how the clinical investigation shallbe conducted and has signed an informed consent form.

  • Patient who reads and understands French.

  • Patient who has undergone clinical screening adapted to the clinical investigation.

Exclusion

Exclusion Criteria:

  • 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 mentallevel, language difficulties or impaired cerebral function.

  • Patient with an active suicidal tendency or patient who has had a suicidal episodein the last 6 months

  • Patients with borderline personality disorders.

  • Patient with a contra-indication to the product(s) under evaluation.

  • Woman of childbearing age without effective contraception.

  • Pregnant woman, birthing or breastfeeding mother

  • Minor (not emancipated)

  • Incapacitated person

Study Design

Total Participants: 104
Treatment Group(s): 1
Primary Treatment: EMOCARE software
Phase:
Study Start date:
March 05, 2025
Estimated Completion Date:
November 04, 2025

Connect with a study center

  • Centre Psychothérapique de Nancy

    Laxou, 54521
    France

    Site Not Available

  • Private psychiatric practice

    Maxéville, 54320
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093
    France

    Site Not Available

  • Centre hospitalier Guillaume Régnier

    Rennes, 35000
    France

    Site Not Available

  • Private psychiatric practice

    Saint Nazaire, 44600
    France

    Active - Recruiting

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