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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary completion date: Jul 2025 to Nov 2026
    • Start date changed from estimate of Mar 2025 to Oct 15, 2025
    • Primary endpoints revised (4)
    • Study completion date: Oct 2025 to Jan 2027
    • Study description shortened, about 21 words
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06759129
Lead Sponsor University of Valencia
Conditions
(from sponsor)
Suicidal Ideation and Behavior, Suicide
Related terms Behavior, Social Stigma, Suicidal Ideation, Suicide, Suicide Prevention
Enrollment 214 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov