Smartphone-based Ecological Momentary Intervention for Secondary Prevention of Suicidal Thoughts and Behavior: a Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Reduction of suicidal ideation
研究概览
简要总结
Introduction: Suicide is one of the leading public health issues worldwide. Mobile health can help us to combat suicide through monitoring and treatment. The SmartCrisis 2.0 randomized clinical trial aims to evaluate the effectiveness of a smartphone-based Ecological Momentary Intervention to prevent suicidal thoughts and behaviour.
Methods and analysis: The SmartCrisis 2.0 study is a randomized clinical trial with two parallel groups, conducted among patients with a history of suicidal behaviour treated at the University Hospital Fundación Jiménez Díaz. The intervention group will be monitored using Ecological Momentary Assessment and will receive an Ecological Momentary Intervention called 'SmartSafe' in addition to their treatment as usual (TAU). TAU will consist of psychiatric follow-up of the patient (scheduled appointments with a psychiatrist) in our outpatient Suicide Prevention clinic, with predetermined clinical appointments according to the Brief Intervention Contact recommendations (1, 2, 4, 7 and 11 weeks, and 4, 6, 9 and 12 months). The control group would receive TAU and be monitored using EMA.
Ethics and dissemination: This study has been approved by the Ethics Committee of the University Hospital Fundación Jiménez Díaz. It is expected that, in the near future, the mobile applications MEmind and eB2 can be implemented in routine clinical practice. Results will be disseminated through peer-reviewed journals and psychiatric congresses.
详细描述
Introduction: Over 800,000 die every year by suicide, while suicide attempts are estimated to be 20 times more frequent. Suicidal ideation (SI) is estimated to affect 2% of the population. Suicidal thoughts and behaviours (STB) increase the risk of death by suicide, impair people's quality of life and result in high healthcare costs.
New technologies can help us in the management and prevention of STB. Among other advantages, these devices open the possibility of implementing smartphone-based real-time monitoring. There are two main types of smartphone-based monitoring: active and passive. The active mode is also known as Ecological Momentary Assessment (EMA). EMA involves asking daily questions, resulting in real-time responses in the patient's usual environment. EMA provides a more accurate picture of the emotional and cognitive context in which SI appears, offering us the opportunity to identify its immediate predictors.
Passive monitoring -also called passive EMA- involves using the mobile phone's native sensors to collect information such as physical activity, mobility or sleep, which can be useful as proxy factors for mental state. The combination of active and passive monitoring produces valuable information to characterize people's behaviour, giving rise to what is known as an individual's digital phenotype (Barrigón et al., 2019). As it does not require patient effort, passive EMA can increase the acceptability of monitoring and counteract the so-called "EMA fatigue", which occurs when patients stop answering EMA questions.
A considerable number of studies have applied EMA technology to suicide research. In contrast, passive EMA has been used scarcely in suicidology.
A further step is to exploit EMA's potential to design digital therapeutic tools, providing continuous support in the patient's usual environment. This is known as Ecological Momentary Intervention (EMI). EMIs can be a useful add-on to traditional treatment, thanks to their 24-hour availability, low cost, and the possibility of continuing follow-up in a non-presential manner. Some studies have explored the effectiveness of EMI on suicidal behaviour, showing good acceptability and a reduction in SI after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting with a SA or an emergency referral for SI in the past month.
- •Being able to understand and sign the informed consent form.
- •Being fluent in Spanish
- •Owning a smartphone with internet access and iOS or Android operating system.
排除标准
- •Refusal to install the mobile application
- •Inability to understand and sign the informed consent form for any reason.
- •Institutionalized or incarcerated patients, without access to regular mobile phone use.
研究组 & 干预措施
Control group
The control group will be monitored using smartphone-based active and passive Ecological Momentary Assessment through the MEmind and eB2 mobile applications, and will receive treatment as usual, which will consist of psychiatric follow-up (scheduled appointments with their psychiatrist) in an outpatient Secondary Suicide Prevention Programme, with predetermined clinical reviews according to the Brief Intervention Contact recommendations (1, 2, 4, 7 and 11 weeks, and 4, 6, 9 and 12 months)
Intervention group
The intervention group will receive an Ecological Momentary Intervention called SmartSafe, will be monitored using smartphone-based active and passive Ecological Momentary Assessment through the MEmind and eB2 mobile applications, and their treatment as usual, which will consist of psychiatric follow-up (scheduled appointments with their psychiatrist) in an outpatient Secondary Suicide Prevention Programme, with predetermined clinical reviews according to the Brief Intervention Contact recommendations (1, 2, 4, 7 and 11 weeks, and 4, 6, 9 and 12 months)
干预措施: SmartSafe (Device)
结局指标
主要结局
Reduction of suicidal ideation
时间窗: 1 year
Our primary outcome will be reduction of suicidal ideation, measured at follow-up using the Columbia Suicide Severity Rating Scale
Reduction of suicidal ideation
时间窗: 6 months
Our primary outcome will be reduction of suicidal ideation, measured at follow-up using the Columbia Suicide Severity Rating Scale
次要结局
- Feasibility of the project: Compliance(1 year)
- Feasibility of the project: Retention(1 year)
- Acceptability of the mobile health applications(1 year)
- Reduction of suicide attempts(1 year)
- Feasibility of the project: Participation(1 year)
- Acceptability of the mobile health applications(6 months)
- Feasibility of the project: Compliance(6 months)
- Reduction of suicide attempts(6 months)