Suicidal BehaviorsSURVIVE 2NCT07554729
AN EXTENDED COHORT STUDY TO INVESTIGATE SUICIDAL BEHAVIOR IN SPAIN (THE SURVIVE 2 STUDY)
An observational study of Suicidal Behaviors, run by Parc de Salut Mar at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Suicidal Behaviors
- How many people
- 3,600 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Sep 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital del Mar
Barcelona, Catalonia, 08041
Matilde Elices, Dr, +34 933160623, melices@researchmar.net
- Recruiting
Hospital Clinic
Barcelona
Iria Grande, + 34 933160623, igrande@clinic.cat
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicidal Behaviors
- Keywords
- suicide, cohort study
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Bruha Life Events
Checklist of major stressful life events; higher counts indicate greater exposure to recent stressors.
Measured: 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.
Measured: baseline
Insomnia Severity Index (ISI)
Five-item self-report scale that measures insomnia symptoms and their impact; total score indicates insomnia severity
Measured: 1 year
Alcohol Use (AUDIT-C)
Three-item self-report questionnaire that screens for hazardous alcohol consumption; higher scores indicate higher risk drinking
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 Sep 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Víctor Pérez, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554729
- Sponsor's protocol ID
- 2023/11342/I
- Other IDs
- PI23/00147, 2023
- Acronym
- SURVIVE 2
- Status last verified
- Jan 2026
- First submitted
- 17 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE SURVIVE 2 PROJECT: AN EXTENDED COHORT STUDY TO INVESTIGATE SUICIDAL BEHAVIOR IN SPAIN AND THE EFFICACY OF SECONDARY PREVENTION STRATEGIES
- ClinicalTrials.gov ID
- NCT07554729
- Acronym / sponsor ID
- SURVIVE 2 / 2023/11342/I
- Conditions
- Suicidal Behaviors
- Keywords
- suicide, cohort study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
18 secondary outcomes
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
UCLA-3 Item Loneliness Scale
Time frame: 1 year
Reflective Functioning Questionnaire - RFQ-8
Time frame: 1 year
Bulimic Investigatory Test, Edinburgh - BITE
Time frame: 1 year
Feelings of Emptiness (CSV)
Time frame: 1 year
Lubben Social Network Scale
Time frame: 1 year
Sociodemographic and Clinical Characteristics (Ad-Hoc Questionnaire)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicidal Behaviors, run by Parc de Salut Mar at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor Perez-Sola, Dr (+34 933160623, vperez@psmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Columbia Suicide Severity Rating Scale (C-SSRS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.