RecruitingNot ApplicableNCT06759129

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

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

Sponsor

University of Valencia

Enrollment

214 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

Suicide Suicidal Ideation and Behavior

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria3

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).

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Interventions

BEHAVIORALImmediate-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.

BEHAVIORALDelayed 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.