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Can a smartphone app lift depression? new trial aims to find out

NCT ID NCT07211984

Symptom relief Sponsor: Dalia Care Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a digital monitoring device called Dalia can improve depression symptoms when added to usual care. About 644 adults with moderate-to-severe depression will use the device for 3 months. The main goal is to see if more people feel significantly better compared to those receiving standard care alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dalia digital telemonitoring device
What this could lead to
If successful, this could offer a new way to track and improve depression care using a smartphone or tablet.
What could go wrong
This is an early-stage trial with no blinding, so results may be influenced by expectations. The device is an add-on, not a standalone treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 644 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 76 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years * Patient with a diagnosis of depressive episode, as defined by ICD-11, and with a PHQ-9 score ≥ 15 confirmed by a psychiatrist or general practitioner * Patient receiving a first antidepressant treatment (treatment-naïve) OR having had a modification of antidepressant treatment in the two weeks prior to inclusion * Patient equipped with a smartphone or a computer or a tablet with internet access * Patient affiliated to a health insurance scheme * Patient able to read and understand French * Patient having signed informed consent Exclusion Criteria: * Patient under non-cardioselective beta-blocker (carvedilol, labetalol, propranolol, pindolol) and beta-mimetic (salbutamol, terbutaline) * Patient with a pacemaker or with a known cardiac arrhythmia * Patient with major neurocognitive disorder (e.g., dementia) or psychotic disorders likely to compromise participation in the study * Patient hospitalized at the time of inclusion whose discharge is not planned within the next two weeks * Patient treated with esketamine * Patient with excessive consumption of psychoactive substances (alcohol or drugs), which may interfere with the course or follow-up of the study * Patient unable to wear the bracelet during the study due to dermatological conditions * Patient under guardianship, curatorship, or legal protection, or any other administrative or judicial measure depriving rights and freedom * Patient considered non-autonomous by the investigator * Patient already included in another interventional research study * Vulnerable persons referred to in Articles L.1121-5 to 8 and L.1122-1-2 of the French Public Health Code are excluded from the study

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Conditions

The condition(s) this trial relates to.

anxiety disorder Consciousness Disorders Depression depressive disorder major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depressed Depressed mood Depression and quality of life Depression chronic Depression diagnosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Neurostim Luxembourg

    Paris, 75005, France

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Other studies related to the condition(s) this trial covers.