Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients Suffering From Unipolar Depression

Emobot98 enrolled

Overview

The aim of this study is to validate the EmoDTx as a digital tool for mood monitoring in adult patients with unipolar depression. The study is prospective, multicenter, and observational, with a single-arm approach. The device studied, EmoDTx, is a mood-monitoring application that analyzes patients' facial expressions to assess their emotional state. The study aims to compare mood scores obtained via EmoDTx with those of standard depression questionnaires (MADRS, PHQ-9, BDI-II, HAMD-17, QIDS-SR16). It will also provide information on how patients feel about the use of passive monitoring software (without the active involvement of the patient) and how the feedback sent to patients can help in their care. 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 8-week follow-up period. 2. Attend scheduled appointments at the center (a first appointment, then a second 4 weeks later, and a final at 8 weeks) to complete a series of questionnaires, be questioned by the doctor, and fill in other questionnaires on their own. 3. At home, answer questionnaires independently, 2 weeks and 6 weeks after the first appointment. 4. The application's feedback will be deactivated during the first 4 weeks and then reactivated during the final 4 weeks. 5. In parallel, an ancillary study will be conducted on 16 patients enrolled in EMC2FR who accepted and performed the video recording of their structured clinical interview following SCID-5-CV at baseline and 4 weeks.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Unipolar Depression Major Depressive Disorder (MDD)Depression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Outpatients diagnosed with mild to severe unipolar disorder 2. Age ≥ 18 years old 3. Patients willing and able to participate (i.e willing to use the EmoDTx App and having the necessary technical equipment to use it) 4. Patients who read, write and understand French 5. Patients having signed the Patient Informed Consent Exclusion criteria: 1. Patients hospitalized 2. Patients taking more than 75% of the maximal recommended daily dose of benzodiazepines 3. Patients taking more than 75% of the maximal recommended daily dose of antipsychotics 4. Patients taking more than 75% of the maximal recommended daily dose of neuroleptics 5. Patients who did not respond to 10 different pharmacological treatments 6. Patients who attempted suicide within the previous last 6 months and presenting with suicidal ideations 7. Patient presenting with bipolar disorders 8. Patients with a contra-indication to the device under evaluation: * Severe depression requiring hospitalization * Schizophrenic disorders according to DSM 5 classification * Major neurocognitive disorders according to DSM 5 classification * Illiteracy * Subject hospitalized in a healthcare or social institution for reasons other than biomedical research or is deprived of freedom by administrative or judicial decision or is placed under guardianship 9. Patients unable to read, write and understand French 10. Patients with no access to a smartphone or a computer with an internet connection 11. Patients who refuse to sign the Patient Informed Consent 12. Patients already participating in another interventional clinical study

Outcomes

Primary Outcomes

Change of score EmoDTx

Absolute difference

Time frame: From baseline to 4 weeks

Change of score MADRS administrated by an investigator

Absolute difference

Time frame: From baseline to 4 weeks

Secondary Outcomes

Change of EmoDTx score

Time frame: Between 2 weeks and 6 weeks

Change of score PHQ-9 self reported

Time frame: Between 2 weeks and 6 weeks

Change of EmoDTx score

Time frame: Between Baseline and 4 weeks, between Baseline and 8 weeks and between 4 weeks and 8 weeks

Change of HAMD-17 questionnaire administered by the investigator

Time frame: Between Baseline and 4 weeks, between Baseline and 8 weeks and between 4 weeks and 8 weeks

Change of EmoDTx score

Time frame: between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks

Change of score QIDS- SR16 self administrated

Time frame: between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks

Change of score BDI-II self administrated

Time frame: between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks

Score EmoDTx

Time frame: At 4-weeks, at 8 week

Score MADRS administrated by the investigator

Time frame: At 4-weeks, at 8 week

Score HAMD-17 administrated by the investigator

Time frame: At 4-weeks, at 8 week

Score PHQ-9 self administrated

Time frame: At 2-weeks and 6 weeks.

Score QIDS-SR16 self administrated

Time frame: At 4-weeks and 8 weeks

To evaluate the ability of EmoDTx to predict changes in patient's mood earlier than the standard-of-care questionnaires HAMD-17, within 4 weeks and 8 weeks of follow-up.

Time frame: Time to detection by EmoDTx of changes to depression severity symptoms within 4 weeks and 8 weeks of follow-up as compared to changes detected by standard-of-care questionnaires HAMD-17 Changes in depression severity

To evaluate the ability of EmoDTx to predict changes in patient's mood earlier than the standard-of-care questionnaires MADRS, within 4 weeks and 8 weeks of follow-up.

Score EQ-5D-5L

Time frame: At 4 weeks and 8 weeks

Change of EmoDTx score when feedback is deactivated

Time frame: From baseline to 4 weeks

Change of EmoDTx score when feedback is activated

Time frame: From 4 weeks to 8 weeks

Acceptability of medical device questionnaire

Time frame: A baseline and 8 weeks

Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients Suffering From Unipolar Depression

Overview

Conditions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts