Suicide Prevention and Intervention (SURVIVE): Cohort Study and Nested Randomized Controlled Trials of Secondary Prevention Programs for Suicide Attempts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,742
- 试验地点
- 16
- 主要终点
- Suicide repetition (or death by suicide)
研究概览
简要总结
Suicide is one of the leading causes of avoidable death worldwide. Gathering population-representative data on the incidence of suicidal behavior, as well as developing effective secondary prevention strategies are imperative parts of evidence-based public health policies, currently lacking in Spain. The Suicide Prevention and Intervention Study (SURVIVE) is a multi-site-cohort study with nested randomized-controlled clinical trials. The principal aims of the SURVIVE study are to determine the incidence of suicide attempts in Spain and to investigate the efficacy of two secondary prevention programs.
详细描述
Suicide is the leading cause of avoidable death worldwide, demanding urgent attention. Collecting national-representative data is the first step towards developing effective evidence-based public-policies.
The SURVIVE study presents four inter-connected objectives:
- To determine the incidence of suicide attempts in Spain
- To follow up suicide attempters with the aim of studying the probability of them re-attempting
- To identify influential risk factors to explain suicide attempts and an increased risk of re-attempting
- To determine the efficacy of secondary prevention programs to prevent suicide re-attempts in comparison to treatment as usual (TAU).
Study design: Multi-site-coordinated cohort study with nested randomized controlled trials. Participants will be recruited at mental-health sites distributed across Spain.
Participants: A cohort of 2.000 individuals presenting a suicide attempt will be established.
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
- None (Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria:
- •Female and males, age >= 12 years
- •Having attended a hospital emergency department due to a suicide attempt
- •Willing and able to comply with study procedures and to give written informed consent
- •Specific inclusion criteria for iFD-S:
- •Minimum knowledge of internet use and availability of an internet device (tablet, computer, smartphone)
- •Depressive symptoms according to PHQ-9 scores above 15
- •Specific inclusion criteria for SAM:
- •Age between 12-17
- •Informed consent of legal guardians
排除标准
- •Incapacity to give informed consent
- •Lack of fluency in Spanish
- •Currently taking part in another clinical study which, in the opinion of the investigator, is likely to interfere with the objectives of the SURVIVE study.
结局指标
主要结局
Suicide repetition (or death by suicide)
时间窗: 12 months
The primary outcome is subsequent suicide attempts (and/or suicide mortality) captured across assessment points. Is a binary variable (yes/no).
次要结局
- Brief Symptoms Inventory(1 month)
- Patient Health Questionnaire 9-items(2 weeks)
- Generalized Anxiety Disorder 7-items(2 weeks)
- Barrat Impulsivity Scale(2 weeks)
- EuroQol 5D(1 day)
- Acquired capability of suicide Scale -Fearlesness about Death(2 weeks)
- Reflective Functioning Questionnaire(2 weeks)
- Columbia Suicide Rating Scale(1 month)
- Strengths and Difficulties Questionnaire (SDQ)(1 month)
研究者
Víctor Pérez
Medical Director
Parc de Salut Mar