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

NCT ID: NCT06759129

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2025-10-31

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.

Conditions

Suicidal Ideation and Behavior; Suicide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Immediate-use

Participants will use the mobile application starting immediately after the baseline assessment (T0) for approximately 14 days or until they complete the app.

Group Type: EXPERIMENTAL

Immediate-use of a mobile health application until completion

Intervention Type: BEHAVIORAL

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.

Delayed use

Participants will start using the application 14 days after the baseline assessment (T0) and immediately after the T1 assessment.

Group Type: ACTIVE_COMPARATOR

Delayed use of a mobile health application until completion

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

iApp; dApp

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Rosa M. Baños Rivera

Full Professor of Psycology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Valencia

Valencia, , Spain

Countries

Spain

Central Contacts

Adriana Mira Pastor, PhD

Role: CONTACT

adriana.mira@uv.es

+34963 86 41 00

Facility Contacts

Adriana Mira Pastor, PhD

Role: primary

adriana.mira@uv.es

+34 963 86 41 00

Rosa María Baños, Professor

Role: backup

Tamara Escrivá-Martínez, PhD

Role: backup

Maitena Pierantonelli, MA

Role: backup

Adriana Mira Pastor, PhD

Role: backup

Other Identifiers

VH9FA3L6BJ015JSE

Identifier Type: -

Identifier Source: org_study_id