AN EXTENDED COHORT STUDY TO INVESTIGATE SUICIDAL BEHAVIOR IN SPAIN (THE SURVIVE 2 STUDY) (SURVIVE 2)

THE SURVIVE 2 PROJECT: AN EXTENDED COHORT STUDY TO INVESTIGATE SUICIDAL BEHAVIOR IN SPAIN AND THE EFFICACY OF SECONDARY PREVENTION STRATEGIES

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.

Study Overview

• Status: Recruiting
• Conditions: Suicidal Behaviors

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.

• Study Type: Observational
• Enrollment (Estimated): 3600

Contacts and Locations

• Study Contact: Name: Victor Perez-Sola, Dr; Phone Number: +34 933160623; Email: vperez@psmar.cat
• Study Contact Backup: Name: Matilde Elices, Dr; Phone Number: +34 933160623; Email: melices@researchmar.net

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Clinic
    • Contact: Iria Grande; Phone Number: + 34 933160623; Email: igrande@clinic.cat
  • Catalonia
    • Barcelona, Catalonia, Spain, 08041
      • Recruiting
      • Hospital Del Mar
      • Contact: Matilde Elices, Dr; Phone Number: +34 933160623; Email: melices@researchmar.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
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.	1 year
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.	1 year
Bruha Life Events	Checklist of major stressful life events; higher counts indicate greater exposure to recent stressors.	1 year
Childhood Trauma Questionnaire (CTQ-SF)	Twenty-eight-item self-report measure that assesses history of childhood maltreatment across five domains (emotional, physical and sexual abuse, and emotional and physical neglect); higher subscale and total scores indicate more severe childhood trauma.	baseline
Insomnia Severity Index (ISI)	Five-item self-report scale that measures insomnia symptoms and their impact; total score indicates insomnia severity	1 year
Alcohol Use (AUDIT-C)	Three-item self-report questionnaire that screens for hazardous alcohol consumption; higher scores indicate higher risk drinking	1 year
Heaviness of Smoking Index (HSI)	Two-item index derived from cigarettes per day and time to first cigarette; higher scores indicate greater nicotine dependence	1 year
Drug Abuse Screening Test (DAST)	Self-report screening tool for problematic use of non-alcohol drugs; total score reflects severity of drug-related problems	1 year
Difficulties in Emotion Regulation Scale (DERS-18)	Eighteen-item self-report measure of problems in emotion regulation across several domains; higher scores reflect greater difficulties regulating emotions.	1 year
Barratt Impulsiveness Scale (BIS-11)	Self-report questionnaire with 30 items that evaluates different facets of impulsivity (attentional, motor and non-planning); higher total scores indicate greater impulsive traits.	1 year
Health-related Quality of Life (EuroQol-5D)	Standardized questionnaire that assesses health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression); higher index values reflect better perceived health.	1 year
UCLA-3 Item Loneliness Scale	Three-item self-report scale that screens for perceived loneliness and social isolation; higher scores indicate greater feelings of loneliness	1 year
Reflective Functioning Questionnaire - RFQ-8	Eight-item self-report questionnaire that assesses difficulties in understanding one's own and others' mental states; scores reflect problems in reflective functioning/mentalizing.	1 year
Bulimic Investigatory Test, Edinburgh - BITE	Self-report questionnaire that evaluates symptoms and severity of bulimic eating behaviors; higher scores indicate more severe bulimic pathology	1 year
Feelings of Emptiness (CSV)	Self-report questionnaire that measures the frequency and intensity of chronic feelings of emptiness; higher scores indicate more severe feelings of emptiness, often associated with borderline and suicidal presentations.	1 year
Lubben Social Network Scale	Brief questionnaire that assesses the size and frequency of supportive contacts with family and friends; lower scores indicate higher risk of social isolation	1 year
Sociodemographic and Clinical Characteristics (Ad-Hoc Questionnaire)	Study-specific questionnaire developed by the research team to collect sociodemographic and basic clinical information (for example age, sex, education, employment, living situation, psychiatric history, and treatment). Data will be used to describe the sample and as covariates in analyses	Baseline

Collaborators and Investigators

• Sponsor: Parc de Salut Mar

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: cohort study; suicide
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Behavior; Suicide
• Other Study ID Numbers: 2023/11342/I; PI23/00147 (Other Grant/Funding Number: Instituto de Salud Carlos III)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because the dataset includes highly sensitive information on suicidal behavior collected in a limited number of centers, which increases the risk of re-identification even after de-identification. Data sharing is therefore restricted to protect participant privacy and comply with ethical and regulatory requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No