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

Official title

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

Overview

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.

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.

Interventions

• 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 in
• 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 evalu

Primary outcome measures

• Suicide public stigma [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 (3)

• Personal suicide stigma [Time frame: 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 [Time frame: 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. [Time frame: 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.]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Prevention

Study locations

Spain · 1 center

• University of Valencia — Valencia

Identifiers

NCT: NCT06759129 · VH9FA3L6BJ015JSE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗