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Can a smartphone app stop a suicidal crisis?

NCT ID NCT04775160

NEW Prevention Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether a smartphone app called SmartSafe can help prevent suicidal thoughts and behavior in people who recently had a suicidal crisis. The app provides a personalized safety plan, check-ins, and coping tools. Participants also receive their usual psychiatric care. The trial compares those who use the app with those who only receive standard care, tracking changes in suicidal ideation over time.

What this could mean

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

Active substance
a smartphone app called SmartSafe that includes a digital safety plan, check-ins, and a mental toolbox
What this could lead to
If it works, this could offer a scalable way to support people between therapy sessions and help prevent suicidal crises.
What could go wrong
The app may not engage users enough to make a difference, and digital tools cannot replace professional care. This is a single-country trial, so results may not apply everywhere.

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 220 people

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

Started

May 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Presenting with a SA or an emergency referral for SI in the past month. * Being able to understand and sign the informed consent form. * Being fluent in Spanish * Owning a smartphone with internet access and iOS or Android operating system. Exclusion Criteria: * Refusal to install the mobile application * Inability to understand and sign the informed consent form for any reason. * Institutionalized or incarcerated patients, without access to regular mobile phone use.

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Conditions

The condition(s) this trial relates to.

Suicide

As listed by the trial registrant

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

Suicide

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

Locations

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

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