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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 214
- 试验地点
- 2
- 主要终点
- Suicide public stigma
研究概览
简要总结
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.
详细描述
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:
- Psychoeducation,
- Interpersonal contact,
- Cognitive flexibility, and
- Values-based work.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Immediate-use
Participants will use the mobile application starting immediately after the baseline assessment (T0) for approximately 10 days or until they complete the app.
干预措施: Immediate-use of a mobile health application until completion (Behavioral)
Delayed use
Participants will start using the application 10 days after the baseline assessment (T0) and immediately after the T1 assessment.
干预措施: Delayed use of a mobile health application until completion (Behavioral)
结局指标
主要结局
Suicide public stigma
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- 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.)
研究者
Rosa M. Baños Rivera
Full Professor of Psycology
University of Valencia