AN EXTENDED COHORT STUDY TO INVESTIGATE SUICIDAL BEHAVIOR IN SPAIN (THE SURVIVE 2 STUDY)
ConditionSuicidal Behaviors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorParc de Salut Mar
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Individuals (adolescents and adults) who present to the emergency departments of participating hospitals in Spain after a suicide attempt. The study will follow approximately 3,600 participants (about 1,800 already enrolled in a previous cohort and about 1,800 newly recruited) for up to 3 years to examine suicidal behavior and related risk and protective factors
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
3,600 Participants
are grouped into 1 trial groupGroup A: Suicide attempt cohort
Trial outcomes
Primary outcomes
1
Columbia Suicide Severity Rating Scale (C-SSRS)
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.
Time frame
1 yearSecondary outcomes
1
Patient Health Questionnaire (PHQ-9)
Nine-item self-report questionnaire that measures the severity of depressive symptoms over the past 2 weeks; total score ranges from 0 to 27, with higher scores indicating more severe depression.
Time frame
1 year2
Generalized Anxiety Disorder (GAD-7)
Brief Description Seven-item self-report questionnaire that assesses symptoms of generalized anxiety during the past 2 weeks; total score ranges from 0 to 21, with higher scores indicating more severe anxiety.
Time frame
1 year3
McLean Screening Instrument for BPD (MSI-BPD)
Self-report questionnaire that screens for symptoms of borderline personality disorder; total score reflects the severity of borderline traits.
Time frame
1 year4
Bruha Life Events
Checklist of major stressful life events; higher counts indicate greater exposure to recent stressors.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov