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RomSi: Mobile Health Intervention to Enhance Suicide Prevention by Reducing Stigma and Increasing Literacy
Sponsor: University of Valencia
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
214
Start Date
2025-10-15
Completion Date
2027-01
Last Updated
2026-05-12
Healthy Volunteers
Yes
Conditions
Interventions
Immediate-use of a mobile health application until completion
Participants will use the RomSi app for approximately 10 days, completing all scheduled activities. Throughout the intervention, they will respond to a daily assessment designed to evaluate stigma, help-seeking intentions, and suicidal ideation. The activities within the app will include interactive games aimed at fostering empathy and emotional understanding. Participants will also have continuous access to specialized help contacts to ensure their well-being during the study. The protocol involves two groups that will receive tailored information based on their specific needs: 1. Individuals with low suicidal ideation and/or self-stigma, who will engage in activities focused on reducing personal stigma. 2. Individuals experiencing suicide bereavement, who will receive support tailored to address their loss and foster resilience. A follow-up will be carried out one month and three months after the end of the intervention.
Delayed use of a mobile health application until completion
Participants assigned to the dApp group (delayed use) will not have access to the RomSi app during the first 10 days of the study. After completing this initial control phase, participants in the dAPP group will begin using the RomSi app, following the same protocol as the iAPP group. This includes interactive activities, such as games designed to foster empathy and understanding, along with continuous access to specialized help contacts. A daily assessment will collect real-time data and evaluate the intervention's impact. This crossover design allows for the immediate effects of the intervention to be compared between groups, while also evaluating changes in pre- and post-intervention measures across both conditions. A follow-up will be carried out one month and three months after the end of the intervention.
Locations (1)
University of Valencia
Valencia, Spain