Clinical trial NCT06759129: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicidal Ideation and Behavior
Suicide
Keywords: Suicide Prevention
Stigma
Suicide Literacy
Help Seeking
Randomized Controlled Trial
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Suicide public stigma
timeFrame: 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.
measure: Suicide literacy
timeFrame: 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.
measure: Intention to seek help
timeFrame: 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.
measure: EMA questionnaire protocol
timeFrame: 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.
Secondary outcomes:
measure: Personal suicide stigma
timeFrame: 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
measure: Suicide grief experience
timeFrame: 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
measure: Stigma by association towards suicide.
timeFrame: 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 outcomes:
measure: Depressive symptoms
timeFrame: 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.
measure: Anxious symptoms
timeFrame: 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.
measure: Suicidal ideation
timeFrame: 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.
measure: Expectations and opinions on the intervention
timeFrame: Immediately before and after the intervention
measure: Usability
timeFrame: Immediately after the intervention
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
References: