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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07554729
Acronym
SURVIVE 2
Enrollment
3600
Registered
2026-04-28
Start date
2024-09-01
Completion date
2026-12-01
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicidal Behaviors

Keywords

suicide, cohort study

Brief summary

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.

Interventions

None listed

Sponsors

Parc de Salut Mar
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Columbia Suicide Severity Rating Scale (C-SSRS)1 yearThe 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

MeasureTime frameDescription
Patient Health Questionnaire (PHQ-9)1 yearNine-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.
Generalized Anxiety Disorder (GAD-7)1 yearBrief 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.
McLean Screening Instrument for BPD (MSI-BPD)1 yearSelf-report questionnaire that screens for symptoms of borderline personality disorder; total score reflects the severity of borderline traits.
Bruha Life Events1 yearChecklist of major stressful life events; higher counts indicate greater exposure to recent stressors.
Childhood Trauma Questionnaire (CTQ-SF)baselineTwenty-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.
Insomnia Severity Index (ISI)1 yearFive-item self-report scale that measures insomnia symptoms and their impact; total score indicates insomnia severity
Alcohol Use (AUDIT-C)1 yearThree-item self-report questionnaire that screens for hazardous alcohol consumption; higher scores indicate higher risk drinking
Heaviness of Smoking Index (HSI)1 yearTwo-item index derived from cigarettes per day and time to first cigarette; higher scores indicate greater nicotine dependence
Drug Abuse Screening Test (DAST)1 yearSelf-report screening tool for problematic use of non-alcohol drugs; total score reflects severity of drug-related problems
Difficulties in Emotion Regulation Scale (DERS-18)1 yearEighteen-item self-report measure of problems in emotion regulation across several domains; higher scores reflect greater difficulties regulating emotions.
Barratt Impulsiveness Scale (BIS-11)1 yearSelf-report questionnaire with 30 items that evaluates different facets of impulsivity (attentional, motor and non-planning); higher total scores indicate greater impulsive traits.
Health-related Quality of Life (EuroQol-5D)1 yearStandardized 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.
UCLA-3 Item Loneliness Scale1 yearThree-item self-report scale that screens for perceived loneliness and social isolation; higher scores indicate greater feelings of loneliness
Reflective Functioning Questionnaire - RFQ-81 yearEight-item self-report questionnaire that assesses difficulties in understanding one's own and others' mental states; scores reflect problems in reflective functioning/mentalizing.
Bulimic Investigatory Test, Edinburgh - BITE1 yearSelf-report questionnaire that evaluates symptoms and severity of bulimic eating behaviors; higher scores indicate more severe bulimic pathology
Feelings of Emptiness (CSV)1 yearSelf-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.
Lubben Social Network Scale1 yearBrief questionnaire that assesses the size and frequency of supportive contacts with family and friends; lower scores indicate higher risk of social isolation
Sociodemographic and Clinical Characteristics (Ad-Hoc Questionnaire)BaselineStudy-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

Countries

Spain

Contacts

CONTACTVictor Perez-Sola, Dr
vperez@psmar.cat+34 933160623
CONTACTMatilde Elices, Dr
melices@researchmar.net+34 933160623

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026