AN EXTENDED COHORT STUDY TO INVESTIGATE SUICIDAL BEHAVIOR IN SPAIN (THE SURVIVE 2 STUDY)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Suicidal Behaviors. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
THE SURVIVE 2 PROJECT: AN EXTENDED COHORT STUDY TO INVESTIGATE SUICIDAL BEHAVIOR IN SPAIN AND THE EFFICACY OF SECONDARY PREVENTION STRATEGIES
Overview
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.
Detailed description
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.
Primary outcome measures
- Columbia Suicide Severity Rating Scale (C-SSRS) [Time frame: 1 year]
Secondary outcome measures (12)
- Patient Health Questionnaire (PHQ-9) [Time frame: 1 year]
- Generalized Anxiety Disorder (GAD-7) [Time frame: 1 year]
- McLean Screening Instrument for BPD (MSI-BPD) [Time frame: 1 year]
- Bruha Life Events [Time frame: 1 year]
- Childhood Trauma Questionnaire (CTQ-SF) [Time frame: baseline]
- Insomnia Severity Index (ISI) [Time frame: 1 year]
- Alcohol Use (AUDIT-C) [Time frame: 1 year]
- Heaviness of Smoking Index (HSI) [Time frame: 1 year]
- Drug Abuse Screening Test (DAST) [Time frame: 1 year]
- Difficulties in Emotion Regulation Scale (DERS-18) [Time frame: 1 year]
- Barratt Impulsiveness Scale (BIS-11) [Time frame: 1 year]
- Health-related Quality of Life (EuroQol-5D) [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 2 centers
- Hospital del Mar — Barcelona
- Hospital Clinic — Barcelona
Identifiers
NCT: NCT07554729 · 2023/11342/I · PI23/00147