Smartphone-based Ecological Momentary Intervention to Help Prevent Suicide
Official title: Smartphone-based Ecological Momentary Intervention for Secondary Prevention of Suicidal Thoughts and Behavior: a Randomised Clinical Trial
Run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · NCT04775160 · Data updated 2026-11-12
A smartphone-based program called SmartSafe is tested to see if it can help prevent suicidal thoughts and behaviors in people recently at risk, alongside usual care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz Academic / other |
| Locations | 1 site (Madrid) |
| Status | Recruiting |
| Started | May 20, 2022 |
| Main results expected | May 19, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT04775160 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults presenting with current suicide risk or recent suicidal ideation who have a smartphone, are fluent in Spanish, and can consent.
✕Probably not a fit
Individuals without access to a compatible smartphone or who cannot use the mobile app may not benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial compares two groups of patients with a recent suicidal crisis or referral for suicidal ideation who are receiving standard psychiatric follow-up. The intervention group uses Ecological Momentary Assessment data plus the SmartSafe Ecological Momentary Intervention in addition to usual care, while the control group receives usual care alone. The study leverages real-time monitoring and mobile interventions to identify and address risk factors as they arise in daily life. Participants must own a smartphone, be fluent in Spanish, and consent to participate. The trial is conducted at Hospital Universitario Fundación Jiménez Díaz in Madrid, with collaboration from a French partner, Centre Hospitalier Régional Universitaire Montpellier.
Why it matters
Potential benefit: If successful, SmartSafe could provide timely support to reduce suicide risk and improve safety for people at imminent risk.
How similar studies have gone: Previous smartphone-based monitoring and intervention approaches have shown promise in reducing risk factors for suicide, but evidence varies by setting and population.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain Recruiting
Study contacts
- Principal investigator: Maria L Barrigon, PhD — Instituto de Investigación Fundación Jiménez Díaz
- Study coordinator: Alejandro A Porras-Segovia, PhD
- Email: alejandro.porras@quironsalud.es
- Phone: 0034915 50 48 00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.