NCT06759129

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: University of Valencia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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. Ecological Momentary Assessments (EMA) 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.

Detailed description

Despite advances in suicide prevention research, implementation faces significant challenges. One major obstacle is stigma, which discourages many at-risk individuals from seeking help and hinders public awareness and societal commitment to addressing this issue openly and responsibly. Public stigma includes negative beliefs, such as perceiving individuals with suicidal thoughts as "weak" or "selfish." This stigma can be internalized by those experiencing suicidal ideation or behaviour, negatively affecting their self-esteem and increasing their distress and isolation due to fear of rejection. Furthermore, family members and friends who have lost a loved one to suicide also face stigma, complicating their grieving process and increasing their risk of depression. This context highlights the need for effective interventions to reduce stigma, encourage help-seeking, and provide support for both at-risk individuals and their loved ones. The goal of this study is to develop and validate a mobile application called RomSi ("Rompiendo el silencio" in Spanish; Breaking the Silence), designed to improve knowledge about suicide, reduce associated stigma, and promote help-seeking behaviours. The app incorporates four intervention approaches that have proven effective in other mental health stigma reduction programs: 1. Psychoeducation, 2. Interpersonal contact, 3. Cognitive flexibility, and 4. Values-based work. Additionally, the app will leverage innovative tools like Ecological Momentary Assessment (EMA) to collect real-time data and personalize the intervention to each participant's needs. Gamification elements will also be used to enhance motivation and engagement throughout the intervention. To evaluate the effectiveness of RomSi, a randomized controlled trial (RCT) with a crossover design will be conducted. Participants will be randomly assigned to one of two groups: * iApp: Immediate use of the app. * dApp: Delayed use (waitlist control). The randomization process will use a computer-generated sequence, concealed from researchers until group assignment, and stratified based on stigma levels toward suicide. Evaluations will occur at five key time points: * T0 (pre-intervention): Initial questionnaires. * T1 (post-intervention): After app completion (iApp) or after 14 days of waiting (dApp). * T2: Follow-up 14 days after T1. * T3: Follow-up 1 month. * T4: Follow-up 3 months. The iApp group will begin using the app immediately after T0 and will have 14 days to complete it, though they may proceed at their own pace. The dApp group will act as a waitlist control, starting the app after completing T1 and following the same evaluation schedule. During the intervention, EMA will be used to measure stigma levels daily, while suicidal ideation and help-seeking behaviors will be assessed at T0, at 7 days, and at the end of the intervention.

Conditions

• Suicidal Ideation and Behavior
• Suicide

Interventions

Type	Name	Description
BEHAVIORAL	Immediate-use of a mobile health application until completion	Participants will use the RomSi app for approximately 14 days, completing all scheduled activities. Throughout the intervention, they will respond to ecological momentary assessments (EMA) 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.
BEHAVIORAL	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 two weeks of the study. During this period, they will complete ecological momentary assessments (EMA) to evaluate stigma, help-seeking intentions, and suicidal ideation, without engaging in the intervention activities associated with the app. 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. 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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-07-01
• Completion: 2025-10-01
• First posted: 2025-01-06
• Last updated: 2025-01-06

Locations

1 site across 1 country: Spain