RomSi mobile app to reduce suicide stigma and boost help-seeking
Official title: RomSi (Rompiendo el Silencio) Mobile Health Intervention to Enhance Suicide Prevention by Reducing Stigma and Increasing Literacy: Protocol for a Cross-Over Randomized Controlled Trial
Run by University of Valencia · NCT06759129 · Data updated 2026-11-12
This project tests the RomSi mobile app to see if it reduces suicide stigma and encourages help-seeking among Spanish-speaking adults, with tailored content for people with low suicidal thoughts and for relatives or friends bereaved by suicide.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 214 (estimated) |
| Sponsor | University of Valencia Academic / other |
| Locations | 1 site (Valencia) |
| Status | Recruiting |
| Started | October 15, 2025 |
| Main results expected | November 2026 |
| Study ends | January 2027 |
| Registry record updated | May 12, 2026 |
| Trial ID | NCT06759129 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are Spanish-speaking adults (18+) with internet-capable phones who do not have high suicidal ideation or acute mental impairment, including people with low suicidal thoughts and family or friends bereaved by suicide.
✕Probably not a fit
People with high suicidal ideation or recent suicide attempts, those scoring high on social desirability, individuals with acute psychosis/intoxication/mania, non-Spanish speakers, or those without a smartphone are unlikely to benefit from this app-based intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study will develop and deploy RomSi, a smartphone app combining psychoeducation, interpersonal contact, cognitive flexibility, and values-based exercises aimed at improving suicide literacy and reducing stigma. Participants will be randomly assigned in a crossover randomized controlled design to immediate or delayed access, with daily assessments collecting real-time data on attitudes and help-seeking behavior. Adults 18+ who speak Spanish and have an internet-capable phone are eligible, while individuals with high suicidal ideation, high social desirability bias, or acute altered mental status are excluded. The trial is coordinated at the University of Valencia and will measure changes in stigma, suicide literacy, and help-seeking over the intervention and follow-up periods.
Why it matters
Potential benefit: If successful, RomSi could lower suicide-related stigma, increase help-seeking, and provide a scalable, easily accessible prevention resource via smartphones.
How similar studies have gone: Components like psychoeducation, interpersonal contact, cognitive flexibility, and values-based work have shown benefits in other mental-health stigma programs, but their combined delivery via a mobile app with a crossover RCT in Spain is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be 18 years old or older. * Have a cell phone with internet access during the intervention and follow-up periods. * Be able to speak, understand, and read in Spanish. Exclusion Criteria: * Presence of high suicidal ideation (measured during screening, with a score above 20 on the total SIDAS scale or between 7 and 10 on the item assessing suicide attempts). * Presence of high social desirability bias (measured during screening, with a score of 14 or higher on the MC-SDS scale). * Altered mental status that impedes the ability to provide informed consent or assent (e.g., acute psychosis, intoxication, or mania).
Where it's running
-
University of Valencia
Valencia, Spain Recruiting
Study contacts
- Study coordinator: Adriana Mira Pastor, PhD
- Email: adriana.mira@uv.es
- Phone: +34963 86 41 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.