RecruitingNAINTERVENTIONAL

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

This important study is testing a new tool called EMOCARE, which is software designed to help monitor emotions. Researchers want to see if EMOCARE gives similar results to the questionnaires doctors currently use to assess people with mild to moderate depression. They also want to understand what it's like for patients to use this type of monitoring software, which works in the background without needing constant input from the user. The main goal is to find out if EMOCARE is reliable and if patients find it helpful, while also noting any medical issues that might come up during its use. This research could lead to new ways of understanding and supporting people living with depression.

At a glance

Status

Recruiting

Phase

Sponsor

Emobot

Enrolment target

104

Start

05 Mar 2025

Estimated completion

04 Feb 2027

Major Depressive Disorder (MDD)

What is this study about?

This study is about a new piece of computer software called EMOCARE, which is designed to keep an eye on how people are feeling emotionally. If you live with depression, you'll know that doctors often use questionnaires to understand your mood and how your treatment is going. This study aims to see if EMOCARE can provide similar, helpful information to these standard questionnaires.

The researchers are particularly interested in two things: firstly, if EMOCARE gives reliable results that match what doctors already use, and secondly, how patients feel about using this kind of software. EMOCARE works in the background, meaning you don't have to actively do much with it once it's set up. This study will help us understand if this 'passive monitoring' is a good way to keep track of emotional well-being and if it could be a useful tool alongside other methods.

Ultimately, the goal is to explore new and easy ways to support people with depression. By comparing EMOCARE to well-known tests like the PHQ-9 (Patient Health Questionnaire), the study hopes to find out if this technology could offer another way for you and your doctor to understand your emotional state better.

Key takeaways

New software (EMOCARE) is being tested for emotional monitoring.
Compares EMOCARE to standard depression questionnaires.
Aims to understand patient experience with passive monitoring.
Study lasts 6 weeks with two in-person visits and phone/home check-ins.
Participants must be diagnosed with mild to moderate depression and use a smartphone/computer.
Your participation helps develop new tools for mental health support.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with depression. Your doctor will use standard questionnaires to confirm your depression is mild to moderately severe. You also need to be comfortable using a smartphone or computer regularly and read and understand French, as the study materials and conversations will be in French.

There are some reasons why you wouldn't be able to join. For example, if you are currently taking certain mental health medications (antipsychotics), have another serious health condition that might interfere with the study, or have had recent thoughts or actions related to harming yourself (suicidal behaviour within the last 6 months).

Additionally, if you find it hard to communicate, have certain personality disorders, or have any other health issue that the doctors think would make it unsafe or unsuitable for you to participate, you would not be able to take part. Women who are pregnant, breastfeeding, or of childbearing age and not using effective contraception also cannot join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of depression (unipolar depression)?
Do you regularly use a smartphone or computer?
Can you read and understand French?
Are you NOT taking antipsychotic medication?
Have you NOT had thoughts or actions related to harming yourself in the last 6 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a selection visit to make sure the study is right for you. During this visit, you'll be able to install the EMOCARE software on your phone or computer, and you can switch it on or off whenever you like during the 6-week study period.

You'll have two in-person appointments at the study centre: one at the beginning and another 6 weeks later. At these appointments, you'll complete some questionnaires on your own and also answer questions from a doctor. In between these visits, you'll answer some more questionnaires at home around 2 weeks and 4 weeks after your first appointment. A doctor will also give you a phone call 3 weeks after your first visit to check in with you and see how you're doing. Throughout the study, you'll be asked to keep a simple diary of any symptoms you notice, doctor visits you have, or changes to any medicines you're taking. The total duration of active participation is 6 weeks.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as closely monitoring your emotional well-being and contributing to research that could help improve mental health support for others. There are minimal known risks with using software like EMOCARE, but as with any study, there's a small chance of unexpected side effects or discomfort. You might also find the questionnaires and appointments take up some of your time. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (11)

Private psychiatric practice
Verified postcode
Agen, France· Recruiting
Private psychiatric pratice
Verified postcode
Caen, France· Recruiting
Centre Psychothérapique de Nancy
Verified postcode
Laxou, France· Not yet recruiting
Private psychiatric practice
Verified postcode
Maxéville, France· Terminated
Private psychiatric practice
Verified postcode
Nantes, France· Recruiting
Centre Hospitalier Universitaire de Nantes
Verified postcode
Nantes, France· Not yet recruiting
Private psychiatric practice
Verified postcode
Paris, France· Not yet recruiting
Private psychiatric practice
Verified postcode
Reims, France· Not yet recruiting
Centre hospitalier Guillaume Régnier
Verified postcode
Rennes, France· Recruiting
Private psychiatric practice
Verified postcode
Saint-Grégoire, France· Recruiting
Private psychiatric practice
Verified postcode
Saint-Nazaire, France· Recruiting

Common questions

What is EMOCARE?

EMOCARE is a new computer software designed to monitor your emotional state and feelings.

How long will the study last if I join?

The study will involve a 6-week period of using the software and having check-ups.

Do I need a special device for EMOCARE?

You'll need a smartphone or computer that you use regularly to install the software.

Will I have to do anything with the EMOCARE software?

EMOCARE works passively in the background, so you won't need to do much with it once it's set up, though you can activate or deactivate it.

What if I feel unwell during the study?

You will have check-ins with your doctor, and you can withdraw from the study at any time if you feel unwell or for any other reason.

How to find out more

Tanel PETELOT

tanel.petelot@emobot.fr +33 6 51 44 26 67 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.