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

NCT06759129 | Not Yet Recruiting

• 1 other identifier: VH9FA3L6BJ015JSE
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation and Behavior; Suicide

Keywords

Suicide Prevention; Stigma; Suicide Literacy; Help Seeking; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (4)

• 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 (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.

• 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 (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.

• 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 (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.

• EMA questionnaire protocol

  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).

  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 (3)

• 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

• 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

• 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.

Other Outcomes (5)

• 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

  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

  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.

Study Arms (2)

Immediate-use

EXPERIMENTAL

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

Behavioral: Immediate-use of a mobile health application until completion

Delayed use

ACTIVE COMPARATOR

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

Behavioral: Delayed use of a mobile health application until completion

Interventions

Immediate-use of a mobile health application until completion 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.

Also known as: iApp

Immediate-use

Delayed use of a mobile health application until completion 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.

Also known as: dApp

Delayed use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, Spain

Location

MeSH Terms

Conditions

Suicidal Ideation; Behavior; Suicide; Suicide Prevention; Social Stigma

Interventions

1-(diethylaminopropyl)-4-phenylpiperazine

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Social Behavior

Central Study Contacts

Adriana Mira Pastor, PhD

CONTACT

+34963 86 41 00; adriana.mira@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Psycology

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: January 6, 2025
• Study Start: March 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)