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

Not Applicable

Not yet recruiting

• Conditions: Suicidal Ideation and Behavior; Suicide

• Registration Number: NCT06759129
• Lead Sponsor: University of Valencia

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. 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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-27
• Last Update Submitted: 2024-12-27
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Study Start: 2025-03
• Primary Completion: 2025-07
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 214

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Suicide public 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.	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 (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.	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 (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.	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.
EMA questionnaire protocol	Public stigma will be assessed daily during the 14-day intervention period. Help-seeking intention and suicidal ideation will be assessed at four specific time points throughout the intervention.	Participants will be assessed daily using ecological momentary assessments (EMA) to evaluate public stigma toward suicide, suicidal ideation, and help-seeking intention. Public stigma will be measured using words derived from the literature and the previously mentioned SOSS questionnaire. 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).

Secondary Outcome Measures

Name	Time	Method
Personal suicide 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	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.
Suicide grief experience	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	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.
Stigma by association towards suicide.	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.	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.

Trial Locations

Locations (1)

University of Valencia; 🇪🇸 Valencia, Spain