THE SURVIVE 2 PROJECT: AN EXTENDED COHORT STUDY TO INVESTIGATE SUICIDAL BEHAVIOR IN SPAIN AND THE EFFICACY OF SECONDARY PREVENTION STRATEGIES
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,600
- 试验地点
- 2
- 主要终点
- Columbia Suicide Severity Rating Scale (C-SSRS)
研究概览
简要总结
The goal of this observational study is to learn more about people who come to emergency departments in Spain after a suicide attempt and to find ways to prevent another attempt. The main questions are whether some personal, social, biological, and clinical factors are linked to a higher risk of trying again, and whether different follow-up strategies can help lower this risk over time.
Researchers will follow a total of about 3,600 people who attempted suicide: around 1,800 who were already recruited in a previous study and about 1,800 new participants who will be added in this project, in several hospitals across Spain.
Some participants may also be invited to give blood samples, answer online questionnaires, or use smartphone-based tools to understand better changes in mood and suicidal thoughts in daily life. A subset of participants may be invited to join separate clinical trials that test different follow-up programs to prevent another suicide attempt; these trials will be registered and described in their own study records.
详细描述
BACKGROUND: Suicide is the leading preventable cause of death in the world. In Spain, the data show a growing trend in recent years, indicating the need to implement evidence-based prevention strategies. OBJECTIVES: The main objective of this study is to continue monitoring a previously established cohort of 1,800 suicide attempts and extend it to include 3,600 cases. The secondary objectives are: 1) to identify risk factors (1a: socioeconomic, psychological, and clinical, 1b: biological, and 1c: genetic) that can predict a repeat attempt, 2) to study suicidal behavior in the pandemic and post-pandemic times, 3) to identify phenotypes related to suicidal ideation and behavior using momentary ecological assessment and 4) to determine the efficacy of secondary prevention programs for suicidal behavior compared with treatment as usual (TaU). METHOD: Multi-center-coordinated cohort study with five nested clinical controlled trials. The participants will be recruited in nine centers distributed in the Spanish territory. The primary variable will be the time to repeat the attempt.
SUB-PROJECT 1: a) long-term follow-up study (5 years) of a cohort of suicide attempts (total n = 3600 cases), b) study of biological and c) genetic markers associated with a suicide attempt. SUB-PROJECT 2: will study suicidal ideation and behavior phenotypes using momentary ecological assessment and experience sampling. SUB-PROJECT 3: will evaluate the efficacy of different secondary prevention programs compared to TaU.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Individuals (above 12 years old) who present to participating Spanish hospital emergency departments after a suicide attempt, as defined by self-injurious behavior with at least some intent to die.
- •Able to understand the study procedures and provide informed consent (or assent with parental/guardian consent for minors, according to local regulations)
- •Sufficient proficiency in Spanish to complete study assessments
排除标准
- •Suicide attempts clearly judged as accidental or without suicidal intent
- •Severe cognitive impairment, intellectual disability, or neurological condition that, in the opinion of the clinical team, prevents valid assessment or informed consent
- •Acute medical instability that makes participation in research procedures unsafe.
- •Any condition or circumstance that, in the opinion of investigators, would seriously interfere with participation or follow-up in the cohort.
研究组 & 干预措施
Suicide attempt cohort
Adults and adolescents who present to participating Spanish hospitals after a suicide attempt and are enrolled in the SURVIVE cohort. This group includes about 1,800 participants from a previous study and about 1,800 newly recruited participants, all followed for up to 3 years.
结局指标
主要结局
Columbia Suicide Severity Rating Scale (C-SSRS)
时间窗: 1 year
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a brief, structured interview that uses simple questions about suicidal thoughts and behaviors to identify whether someone is at risk for suicide and how severe and urgent that risk is.
次要结局
- Patient Health Questionnaire (PHQ-9)(1 year)
- Generalized Anxiety Disorder (GAD-7)(1 year)
- McLean Screening Instrument for BPD (MSI-BPD)(1 year)
- Bruha Life Events(1 year)
- Childhood Trauma Questionnaire (CTQ-SF)(baseline)
- Insomnia Severity Index (ISI)(1 year)
- Alcohol Use (AUDIT-C)(1 year)
- Heaviness of Smoking Index (HSI)(1 year)
- Drug Abuse Screening Test (DAST)(1 year)
- Difficulties in Emotion Regulation Scale (DERS-18)(1 year)
- Barratt Impulsiveness Scale (BIS-11)(1 year)
- Health-related Quality of Life (EuroQol-5D)(1 year)
- UCLA-3 Item Loneliness Scale(1 year)
- Reflective Functioning Questionnaire - RFQ-8(1 year)
- Bulimic Investigatory Test, Edinburgh - BITE(1 year)
- Feelings of Emptiness (CSV)(1 year)
- Lubben Social Network Scale(1 year)
- Sociodemographic and Clinical Characteristics (Ad-Hoc Questionnaire)(Baseline)
研究者
Víctor Pérez
Doctor
Parc de Salut Mar