Suicide, AttemptedCSRC-EpiNCT04235127
The Catalonia Suicide Risk Code Epidemiology Study: an Epidemiological Study of Suicide Attempts in Catalonia, Spain
An observational study of Suicide, Attempted and Suicide, run by Hospital del Mar Research Institute (IMIM).
Trial summary
Suicide attempts (SA) constitute a major public health issue worldwide. Research suggests that 2.7% of adult people ever attempt suicide; among children and adolescents this is estimated to be 6.0%. SA are related to subsequent suicide which represents an annual loss of 34.6 million years of life worldwide. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Suicide, Attempted, Suicide, Suicide and Self-harm
- What is being tested?
- sociodemographic variables, somatic conditions, mental disorders, treatment and drug use
- How many people
- 186,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 2019
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The target population consists of the dynamic cohort of all Catalan residents during the 6-year period 2014-2019.
Who may be able to join
- Catalan residency during 2014-2019
- age 10 or more at end of observation period
Who cannot join
- none
About this study
Official title: The Catalonia Suicide Risk Code Epidemiology Study: a Two-Stage Exposure-Enriched Nested Case-Control Study of Suicide Attempts in Catalonia, Spain
Suicide attempts (SA) constitute a major public health issue worldwide. Research suggests that 2.7% of adult people ever attempt suicide; among children and adolescents this is estimated to be 6.0%. SA are related to subsequent suicide which represents an annual loss of 34.6 million years of life worldwide. Suicide attempts are also related to persistent physical and mental health issues, psychiatric hospitalizations, impaired academic performance, unemployment, partner abuse victimization and perpetration, having children removed by social services, loneliness, relationship difficulties, impaired social functioning and low life satisfaction. Despite this considerable societal impact, there is a lack of epidemiological research focussing on providing suicide attempt surveillance in the population, to inform public health action aimed at reducing risk for suicide attempts in the population, and to provide data-driven support for suicide risk assessment across healthcare settings. To address this shortcoming, the investigators designed the Catalonia Suicide Risk Code Epidemiology study. Using centralized Electronic Healthcare Record data from the entire public healthcare system of Catalonia, Spain, the CSRC-Epi study aims to estimate reliable suicide incidence rates, identify suicide attempt risk factors, and develop validated suicide attempt risk prediction tools.
- Conditions
- Suicide, Attempted, Suicide, Suicide and Self-harm
- Being tested
- sociodemographic variables, somatic conditions, mental disorders, treatment and drug use
- Keywords
- nested case-control study, electronic healthcare records, register-based study, incidence, risk factors, risk prediction, machine learning techniques, inverse probability weighting, public health, surveillance, population-attributable risk proportions
- Medical subject headings
- Suicide, Attempted, Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sociodemographic variables, somatic conditions, mental disorders, treatment and drug useOther
- sociodemographic variables
- history of self-injurious behaviours; all types of somatic conditions; neurodevelopmental, mental, behavioural, personality and substance use disorders; all types of medical procedures performed; and number and type of healthcare contacts.
- prescriptions for psychopharmacological products
- the Suicidal Scale of the Mini-International Neuropsychiatric Interview, the type and lethality of the attempt that warranted evaluation, presence and type of mental disorder, hopelessness, impulsivity, aggressiveness, altered state of conscience, use or dependence of alcohol, use or dependence of illicit drugs, serious somatic disease (including chronic diseases, chronic pain, and disabilities), living status, presence of family or social support, social problems, stressful life events, access to lethal means, and family history of suicide
| Study group | Role | What they receive |
|---|---|---|
| Catalan population | The target population consists of the dynamic cohort of all Catalan residents during the 6-year period 2014-2019. Annual total population of Catalonia is between 7.5-7.6 million, with annual rates for immigration, emigration, birth and death being ~2.5%, ~1.9%, ~0.9%, and ~0.8%, respectively. Based on these figures, we expect a maximum of ~9.1 million individuals with Catalan residency status on at least one point in time over the 2014-2019 period. However, we expect SA in Catalonia to be extremely rare before the age of 10, in line with findings that self-injurious behaviour generally occurs as from the adolescent period. We will therefore exclude cases and controls that have not reached age 10 by the end of the 2014-2019 period (i.e., ~10.9%), lowering the total expected target population to ~8.1 million. Receives: Other: sociodemographic variables, somatic conditions, mental disorders, treatment and drug use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of catalan residents with suicide attempt (incidence)
Suicide attempt is a nonfatal, self-directed, potentially injurious behaviour with a non-zero degree of intent to die as a result of the behaviour, even if the behaviour does not result in injury
Measured: 2014-2019
Secondary outcomes (1)
Number of Catalan residents committing suicide (incidence)
Suicide is a fatal, self-directed, injurious behaviour with a non-zero degree of intent to die as a result of the behaviour
Measured: 2014-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study startJun 2014
- Primary completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 186,000 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Hospital del Mar Research Institute (IMIM)
- Sponsor type
- University, hospital or other
- Collaborators
- Catalan Agency for Health Information, Assessment and Quality, National Centre for Suicide Research and Prevention, Norway, Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Jordi Alonso, Hospital del Mar Research Institute (IMIM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235127
- Sponsor's protocol ID
- CSRC-EPI (2017/7431/I)
- Acronym
- CSRC-Epi
- Status last verified
- Jan 2020
- First submitted
- 16 Jan 2020
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mortier P, Vilagut G, Puertolas Gracia B, De Ines Trujillo A, Alayo Bueno I, Ballester Coma L, Blasco Cubedo MJ, Cardoner N, Colls C, Elices M, Garcia-Altes A, Gene Badia M, Gomez Sanchez J, Martin Sanchez M, Morros R, Prat Pubill B, Qin P, Mehlum L, Kessler RC, Palao D, Perez Sola V, Alonso J; CODIRISC Epidemiology Study Group. Catalonia Suicide Risk Code Epidemiology (CSRC-Epi) study: protocol for a population-representative nested case-control study of suicide attempts in Catalonia, Spain. BMJ Open. 2020 Jul 12;10(7):e037365. doi: 10.1136/bmjopen-2020-037365.
PubMed 32660952
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Catalonia Suicide Risk Code Epidemiology Study: a Two-Stage Exposure-Enriched Nested Case-Control Study of Suicide Attempts in Catalonia, Spain
- ClinicalTrials.gov ID
- NCT04235127
- Acronym / sponsor ID
- CSRC-Epi / CSRC-EPI (2017/7431/I)
- Conditions
- Suicide, Attempted, Suicide, Suicide and Self-harm
- Keywords
- nested case-control study, electronic healthcare records, register-based study, incidence, risk factors, risk prediction, machine learning techniques, inverse probability weighting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 186,000 participants (estimated)
- Lead sponsor
- Hospital del Mar Research Institute (IMIM)University, hospital or other
- Collaborators
- Catalan Agency for Health Information, Assessment and Quality, National Centre for Suicide Research and Prevention, Norway, Harvard Medical School (HMS and HSDM)
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- First posted
- 21 Jan 2020 (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.
Suicide attempts (SA) constitute a major public health issue worldwide. Research suggests that 2.7% of adult people ever attempt suicide; among children and adolescents this is estimated to be 6.0%. SA are related to subsequent suicide which represents an annual loss of 34.6 million years of life worldwide. Suicide attempts are also related to persistent physical and mental health issues, psychiatric hospitalizations, impaired academic performance, unemployment, partner abuse victimization and perpetration, having children removed by social services, loneliness, relationship difficulties, impaired social functioning and low life satisfaction. Despite this considerable societal impact, there is a lack of epidemiological research focussing on providing suicide attempt surveillance in the population, to inform public health action aimed at reducing risk for suicide attempts in the population, and to provide data-driven support for suicide risk assessment across healthcare settings. To address this shortcoming, the investigators designed the Catalonia Suicide Risk Code Epidemiology study. Using centralized Electronic Healthcare Record data from the entire public healthcare system of Catalonia, Spain, the CSRC-Epi study aims to estimate reliable suicide incidence rates, identify suicide attempt risk factors, and develop validated suicide attempt risk prediction tools.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 6 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catalan population | – | Other: sociodemographic variables, somatic conditions, mental disorders, treatment and drug useThe target population consists of the dynamic cohort of all Catalan residents during the 6-year period 2014-2019. Annual total population of Catalonia is between 7.5-7.6 million, with annual rates for immigration, emigration, birth and death being ~2.5%, ~1.9%, ~0.9%, and ~0.8%, respectively. Based on these figures, we expect a maximum of ~9.1 million individuals with Catalan residency status on at least one point in time over the 2014-2019 period. However, we expect SA in Catalonia to be extremely rare before the age of 10, in line with findings that self-injurious behaviour generally occurs as from the adolescent period. We will therefore exclude cases and controls that have not reached age 10 by the end of the 2014-2019 period (i.e., ~10.9%), lowering the total expected target population to ~8.1 million. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target population consists of the dynamic cohort of all Catalan residents during the 6-year period 2014-2019.
Key inclusion criteria (2 listed)
- Catalan residency during 2014-2019
- age 10 or more at end of observation period
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sociodemographic variables, somatic conditions, mental disorders, treatment and drug use* sociodemographic variables * history of self-injurious behaviours; all types of somatic conditions; neurodevelopmental, mental, behavioural, personality and substance use disorders; all types of medical procedures performed; and number and type of healthcare contacts. * prescriptions for psychopharmacological products * the Suicidal Scale of the Mini-International Neuropsychiatric Interview, the type and lethality of the attempt that warranted evaluation, presence and type of mental disorder, hopelessness, impulsivity, aggressiveness, altered state of conscience, use or dependence of alcohol, use or dependence of illicit drugs, serious somatic disease (including chronic diseases, chronic pain, and disabilities), living status, presence of family or social support, social problems, stressful life events, access to lethal means, and family history of suicide | Other | Catalan population |
Primary outcome
Number of catalan residents with suicide attempt (incidence)
Time frame: 2014-2019
Suicide attempt is a nonfatal, self-directed, potentially injurious behaviour with a non-zero degree of intent to die as a result of the behaviour, even if the behaviour does not result in injury
1 secondary outcome
Number of Catalan residents committing suicide (incidence)
Time frame: 2014-2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Derived from this study: PubMed 32660952Mortier P, Vilagut G, Puertolas Gracia B, De Ines Trujillo A, Alayo Bueno I, Ballester Coma L, Blasco Cubedo MJ, Cardoner N, Colls C, Elices M, Garcia-Altes A, Gene Badia M, Gomez Sanchez J, Martin Sanchez M, Morros R, Prat Pubill B, Qin P, Mehlum L, Kessler RC, Palao D, Perez Sola V, Alonso J; CODIRISC Epidemiology Study Group. Catalonia Suicide Risk Code Epidemiology (CSRC-Epi) study: protocol for a population-representative nested case-control study of suicide attempts in Catalonia, Spain. BMJ Open. 2020 Jul 12;10(7):e037365. doi: 10.1136/bmjopen-2020-037365.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide, Attempted and Suicide, run by Hospital del Mar Research Institute (IMIM).
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of catalan residents with suicide attempt (incidence) (time frame: 2014-2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04235127, which also lists 1 linked publication.
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 Jan 2020.