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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Suicide public stigma — Assessments will be conducted at enrollment, immediately after app completion (10 days after enrollment for the iApp group or at the end of the control phase for the dApp group), and at one-month and three-month follow-ups.
  Public stigma will be assessed using the Spanish version of the Stigma of Suicide Scale - Short Form (SOSS-SF). This scale includes 16 adjectives that prototypically describe a person who has died by suicide. It is designed for use with the general population and identifies three distinct factors: (1) Stigma (e.g., pathetic), (2) glorification/Normalization (e.g., brave), and (3) isolation/Depression (e.g., lonely). Each item is rated on a 5-point Likert scale, where higher scores indicate stronger agreement with the adjective as a representation of a prototypical suicidal person.
• Suicide literacy — Assessments will be conducted at enrollment, immediately after app completion (10 days after enrollment for the iApp group or at the end of the control phase for the dApp group), and at one-month and three-month follow-ups.
  The Literacy of Suicide Scale - Short Form (LOSS-SF) will be used to assess levels of suicide-related knowledge. The Spanish validation comprises 10 items divided into four domains: (1) signs and symptoms, (2) causes or nature, (3) risk factors, and (4) treatment and prevention. Responses are provided on a three-point scale ("true," "false," "don't know"). Each correct response is awarded one point, with higher scores indicating greater literacy about suicide.
• Intention to seek help — Assessments will be conducted at enrollment, immediately after app completion (10 days after enrollment for the iApp group or at the end of the control phase for the dApp group), and at one-month and three-month follow-ups.
  The General Help-Seeking Questionnaire (GHSQ) measures the intention to seek help from various sources. Participants rate 10 items regarding their likelihood of seeking help on a 7-point scale ranging from 1 (extremely unlikely) to 7 (extremely likely) for 10 different help sources. The questionnaire provides an overall score and two subscale scores: formal help sources and informal help sources, with higher scores indicating greater help-seeking intention.
• Daily assessment questionnaire protocol — Public stigma will be assessed daily during the 10-day intervention period. Help-seeking intention and suicidal ideation will be assessed at three specific time points throughout the intervention.
  Participants will be assessed daily using a brief self-report assessment to evaluate public stigma toward suicide, suicidal ideation, and help-seeking intention. Public stigma will be measured using words derived from the literature. Help-seeking intention will be assessed with a specific item, while suicidal ideation will be evaluated using the Spanish version of the Suicidal Ideation Attributes Scale (SIDAS).

Trial sites (1)

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