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NCT Number: NCT07554729

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

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital del Mar, Barcelona, Catalonia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: 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.

Secondary outcomes

  1. Patient Health Questionnaire (PHQ-9)

    Time frame: 1 year

    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.

  2. Generalized Anxiety Disorder (GAD-7)

    Time frame: 1 year

    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.

  3. McLean Screening Instrument for BPD (MSI-BPD)

    Time frame: 1 year

    Self-report questionnaire that screens for symptoms of borderline personality disorder; total score reflects the severity of borderline traits.

  4. Bruha Life Events

    Time frame: 1 year

    Checklist of major stressful life events; higher counts indicate greater exposure to recent stressors.

  5. Childhood Trauma Questionnaire (CTQ-SF)

    Time frame: baseline

    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.

  6. Insomnia Severity Index (ISI)

    Time frame: 1 year

    Five-item self-report scale that measures insomnia symptoms and their impact; total score indicates insomnia severity

  7. Alcohol Use (AUDIT-C)

    Time frame: 1 year

    Three-item self-report questionnaire that screens for hazardous alcohol consumption; higher scores indicate higher risk drinking

  8. Heaviness of Smoking Index (HSI)

    Time frame: 1 year

    Two-item index derived from cigarettes per day and time to first cigarette; higher scores indicate greater nicotine dependence

  9. Drug Abuse Screening Test (DAST)

    Time frame: 1 year

    Self-report screening tool for problematic use of non-alcohol drugs; total score reflects severity of drug-related problems

  10. Difficulties in Emotion Regulation Scale (DERS-18)

    Time frame: 1 year

    Eighteen-item self-report measure of problems in emotion regulation across several domains; higher scores reflect greater difficulties regulating emotions.

  11. Barratt Impulsiveness Scale (BIS-11)

    Time frame: 1 year

    Self-report questionnaire with 30 items that evaluates different facets of impulsivity (attentional, motor and non-planning); higher total scores indicate greater impulsive traits.

  12. Health-related Quality of Life (EuroQol-5D)

    Time frame: 1 year

    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.

  13. UCLA-3 Item Loneliness Scale

    Time frame: 1 year

    Three-item self-report scale that screens for perceived loneliness and social isolation; higher scores indicate greater feelings of loneliness

  14. Reflective Functioning Questionnaire - RFQ-8

    Time frame: 1 year

    Eight-item self-report questionnaire that assesses difficulties in understanding one's own and others' mental states; scores reflect problems in reflective functioning/mentalizing.

  15. Bulimic Investigatory Test, Edinburgh - BITE

    Time frame: 1 year

    Self-report questionnaire that evaluates symptoms and severity of bulimic eating behaviors; higher scores indicate more severe bulimic pathology

  16. Feelings of Emptiness (CSV)

    Time frame: 1 year

    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.

  17. Lubben Social Network Scale

    Time frame: 1 year

    Brief questionnaire that assesses the size and frequency of supportive contacts with family and friends; lower scores indicate higher risk of social isolation

  18. Sociodemographic and Clinical Characteristics (Ad-Hoc Questionnaire)

    Time frame: Baseline

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Matilde Elices, Dr

CONTACT

[email protected]

+34 933160623

Victor Perez-Sola, Dr

CONTACT

[email protected]

+34 933160623

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

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

Acronym: SURVIVE 2

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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