Active not recruitingNAINTERVENTIONAL

Detection Algorithm for Recurrence or Relapse of Depression Thanks to a Smartwach

This study is exploring a new way to help people who have experienced depression. It uses a special smartwatch and a phone app called Dalia. The Dalia app is designed to track things like your heart activity and sleep quality, along with your moods. The idea is to see if these measurements can help detect early signs that depression might be returning, sometimes called a relapse or recurrence. By spotting these signs sooner, doctors might be able to offer support and treatment more quickly, potentially making it easier to manage depression and improve overall well-being. The study aims to see how well Dalia can do this compared to a doctor's diagnosis.

At a glance

Status

Active not recruiting

Phase

Sponsor

Dalia Care

Enrolment target

800

Start

19 Dec 2024

Estimated completion

18 Feb 2026

Depressive Disorder Depressive Disorder, Major Depressive Disorder Depressive Disorder Not Otherwise Specified (NOS)

What is this study about?

Depression is a common illness that affects many people around the world, making them feel very low and losing interest in things they once enjoyed. While treatments can help, it's quite common for depression to come back, especially after the first time. Each time it returns, the risk of it happening again often goes up. When depression returns, it can be very difficult and can affect many parts of a person's life.

This study is looking at a new tool to help manage depression. It's called Dalia, and it's a mobile app that works with a special smartwatch. Dalia keeps an eye on different parts of your health, like your sleep patterns, how your heart is working, and changes in your mood. The project was created with input from both patients and mental health doctors, aiming to make it as helpful as possible.

The main goal of this study is to see if Dalia can effectively spot the early warning signs that depression might be returning, even before a person or their doctor might fully recognise it. By understanding how Dalia performs, doctors hope to find better ways to help people with depression receive timely support, which could make a big difference in how they manage their condition.

Key takeaways

The study uses a smartwatch and app to monitor for early signs of depression returning.
It hopes to improve how depression is managed by allowing for quicker support.
The Dalia app was designed with input from patients and doctors.
Participation involves wearing a smartwatch and using an app to track health data.
This study is for adults over 18 who have recovered or are in remission from depression.

Who may be eligible?

To join this study, you need to be at least 18 years old and living in France. You should be in a period where your depression has improved or gone away, as confirmed by a psychiatrist within the last six months.

You'll also need your own smartphone, computer, or tablet that can connect to the internet, and you should be able to speak French. You must be signed up to a social security scheme in France.

There are some conditions that would mean you can't take part. For example, if you're taking certain heart medications, have a pacemaker, or certain heart rhythm problems. People with substance use disorders in the last six months, or those with certain thinking or mental health conditions (like dementia, schizophrenia, bipolar disorder, or severe anxiety disorders) would also not be able to join. Your doctor will also check if you are able to understand and follow the study instructions, and if you can wear a smartwatch for the whole study.

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?
Have you recently recovered from a depressive episode (within the last 6 months)?
Do you own a smartphone, computer, or tablet with internet access?
Do you live in France and have health insurance there?
Do you not have certain heart conditions or other serious mental health conditions?

Answer every question to see your result.

What does participation involve?

This section is not fully detailed in the provided clinical trial information. However, based on the brief summary, participation would involve wearing a special smartwatch and using the Dalia mobile application. The app would monitor various health signs like heart activity, sleep quality, and moods. The goal is to collect this information to see if changes in these measurements can predict the return of depression. The length of time you'd need to wear the smartwatch and use the app isn't specified, but it would involve regular monitoring during a period where your depression has improved or gone. There's no mention of specific hospital visits or taking new medications as part of this study, but regular communication about your mood would likely be involved. You would also have check-ups with a psychiatrist to confirm your depression status.

Potential risks and benefits

Taking part in this study could offer some potential benefits, as it aims to find better ways to detect when depression might be returning, potentially leading to earlier support. However, there are no direct health benefits guaranteed from participating. Risks are generally low; wearing a smartwatch is usually safe, but some people might find it uncomfortable or get skin irritation. Your personal data would be collected, but strict privacy rules would be followed. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Hôpital Saint-Antoine
Verified postcode
Paris, France

Common questions

What is the main goal of this study?

The study aims to see if a special smartwatch and app (Dalia) can detect early signs that depression might be returning (a relapse or recurrence).

Who developed the Dalia app?

The Dalia app was created with help from both patients and mental health doctors.

What kind of information does the smartwatch track?

It tracks things like your heart activity, sleep quality, and your moods.

What happens if depression returns while I'm in the study?

The study is designed to identify this early, so doctors can learn if Dalia can help provide timely support, but it does not specify direct intervention mechanisms within the study itself.

Do I have to live in France to join?

Yes, you need to live in France and be covered by a social security scheme there to participate in this study.