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

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.

Study Overview

• Status: Recruiting
• Conditions: Suicide; Suicidal Ideation and Behavior
• Intervention / Treatment: Behavioral: Immediate-use of a mobile health application until completion; Behavioral: Delayed use of a mobile health application until completion

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 a daily assessment to collect real-time data. 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 10 days of waiting (dApp).
• T2: Follow-up 10 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 10 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, a daily assessment will be used to measure stigma levels, as well as suicidal ideation and help-seeking intentions.

• Study Type: Interventional
• Enrollment (Estimated): 214
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adriana Mira Pastor, PhD; Phone Number: +34963 86 41 00; Email: adriana.mira@uv.es

Study Locations

• Spain
  • Valencia, Spain
    • Recruiting
    • University of Valencia
    • Contact: Adriana Mira Pastor, PhD; Phone Number: +34 963 86 41 00; Email: adriana.mira@uv.es
    • Sub-Investigator: Rosa María Baños, Professor
    • Sub-Investigator: Tamara Escrivá-Martínez, PhD
    • Sub-Investigator: Maitena Pierantonelli, MA
    • Principal Investigator: Adriana Mira Pastor, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate-use; Participants will use the mobile application starting immediately after the baseline assessment (T0) for approximately 10 days or until they complete the app.	Behavioral: 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: Individuals with low suicidal ideation and/or self-stigma, who will engage in activities focused on reducing personal stigma.; 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.; Other Names: iApp
Active Comparator: Delayed use; Participants will start using the application 10 days after the baseline assessment (T0) and immediately after the T1 assessment.	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 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.; Other Names: dApp

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicide public stigma	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.	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.
Suicide literacy	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.	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.
Intention to seek help	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.	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.
Daily assessment questionnaire protocol	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).	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal suicide stigma	The Personal Suicide Stigma Questionnaire (PSSQ) will be used to assess individuals' perceptions of social responses to their experiences with suicidal behaviour. It comprises 16 items rated on a 5-point Likert scale (1 = never to 5 = very often) and includes three subscales: Rejection, Minimization, and Self-Blame. The total score ranges from 16 to 80, with higher scores indicating greater experiences of suicide-related stigma.	This measure will only be implemented for participants with low or moderate suicidal ideation. Assessments will be conducted at enrollment, immediately after app completion (14 days after enrollment for the iApp group or at the end of the control phase f
Suicide grief experience	The Grief Experience Questionnaire (GEQ) will be used to assess feelings arising from the experience of suicide among individuals close to the deceased. The scale consists of 55 items that measure the frequency of specific reactions experienced during the two years following the loss, rated on a 5-point Likert scale (1 = never to 5 = almost always). The items are distributed across 11 subscales.	This measure will only be implemented for participants who indicate bereavement as a consequence of suicide in the screening. Assessments will be conducted at enrollment, immediately after app completion (14 days after enrollment for the iApp group or at
Stigma by association towards suicide.	The Stigma of Suicide and Suicide Survivor Scale (STOSASS) will be used to assess perceived stigma toward suicide and suicide survivors. The tool consists of two subscales: one for stigma toward suicide and another for stigma toward survivors, each comprising 13 items rated on a 4-point scale (1 to 4). The total score is calculated as the average of the 13-item scores, with higher total scores indicating greater perceived stigma.	Assessments will be conducted at enrollment, immediately after app completion (14 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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	The Patient Health Questionnaire-9 (PHQ-9) will be administered. This is a nine-item scale based on the DSM-IV diagnostic criteria for major depression. Responses are recorded on a 4-point Likert scale reflecting the frequency of symptoms over the past two weeks, ranging from 0 ("Never") to 3 ("Nearly every day"). Additionally, the final question assesses the level of difficulty these issues have caused, using a 4-point Likert scale from 1 ("Not difficult at all") to 4 ("Extremely difficult"). Higher scores indicate greater severity of depressive symptoms.	Assessments will be conducted at enrollment, immediately after app completion (14 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.
Anxious symptoms	The Generalized Anxiety Disorder 7-item scale (GAD-7) will be administered to assess the presence and severity of generalized anxiety disorder. Participants will respond to 7 items regarding the frequency of their experiences over the past two weeks, using a scale ranging from 0 ("Not at all") to 3 ("Nearly every day").	Assessments will be conducted at enrollment, immediately after app completion (14 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.
Suicidal ideation	The severity of suicidal ideation will be assessed using the Suicidal Ideation Attributes Scale (SIDAS), which consists of 5 items. These items evaluate the frequency of suicidal thoughts (item 1), the ability to control them (item 2), proximity to a suicide attempt (item 3), associated distress (item 4), and interference with daily activities (item 5) over the past month. Responses are recorded on an 11-point Likert scale, with scores above 21 indicating a high risk of suicidal behavior.	Assessments will be conducted at enrollment, immediately after app completion (14 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.
Expectations and opinions on the intervention	Expectations and Opinion of Treatment Scales consist of two 5-item scales that provide a subjective measure of participants' expectations and opinions about the treatment. Items are rated on a 0-to-10 Likert scale, with higher scores indicating more positive expectations or opinions.	Immediately before and after the intervention
Usability	The System Usability Scale (SUS) is a 10-item questionnaire that evaluates the usability of a technological application.	Immediately after the intervention

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 27, 2024
• First Posted (Actual): January 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Stigma; Suicide Prevention; Suicide Literacy; Help Seeking
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Social Behavior; Suicide Prevention; Suicide; Suicidal Ideation; Behavior; Social Stigma; 1-(diethylaminopropyl)-4-phenylpiperazine
• Other Study ID Numbers: VH9FA3L6BJ015JSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No