NCT06759129 RomSi: Mobile Health Intervention to Enhance Suicide Prevention by Reducing Stigma and Increasing Literacy
| NCT ID | NCT06759129 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Valencia |
| Condition | Suicidal Ideation and Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 214 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 214 participants in total. It began in 2025-10-15 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06759129 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Suicidal Ideation and Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06759129 currently recruiting?
Yes, NCT06759129 is actively recruiting participants. Contact the research team at adriana.mira@uv.es for enrollment information.
Where is the NCT06759129 trial being conducted?
This trial is being conducted at Valencia, Spain.
Who is sponsoring the NCT06759129 clinical trial?
NCT06759129 is sponsored by University of Valencia. The trial plans to enroll 214 participants.