RomSi mobile app to reduce suicide stigma and boost help-seeking
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Valencia Academic / other |
| Locations | 1 site (Valencia) |
| Trial ID | NCT06759129 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Valencia
- University of Valencia — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Adriana Mira Pastor, PhD
- Email: adriana.mira@uv.es
- Phone: +34963 86 41 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.