RomSi: Mobile Health Intervention to Enhance Suicide Prevention by Reducing Stigma and Increasing Literacy

Suicide is one of the leading causes of death in Spain, representing a public health crisis that requires urgent and effective solutions. The stigma surrounding suicide prevents many at-risk individuals from seeking help, worsening the problem. Addressing this stigma is essential to implement more effective and accessible prevention strategies. This study aims to design and evaluate an innovative mobile health intervention to reduce stigma and encourage help-seeking behaviours in the general population. While the intervention targets the general population, two specific groups will access specialized and tailored content: individuals with low suicidal ideation and family members or close friends of people who have died by suicide. A daily assessment will collect real-time data and evaluate the intervention's impact. The study will employ a randomised controlled trial (RCT) with a crossover design, with participants randomly assigned to immediate or delayed use conditions. The intervention's effectiveness and usability will be assessed at four key points through quantitative analyses and qualitative interviews. We hypothesise that the intervention will improve suicide literacy, reduce suicide-related stigma, increase help-seeking behaviours, and demonstrate high usability and acceptability.

NCT Number	NCT06759129
Lead Sponsor	University of Valencia
Conditions	Suicidal Ideation and Behavior, Suicide
Enrollment	214 participants
Start Date	2025-10-15
Primary Completion	2026-11 (estimated)
Study Completion	2027-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-12