Clinical trial NCT07021404: The Epidemiology of Suicide Attempts and Suicidal Thoughts in Flanders
Official title: The Epidemiology of Suicide Attempts and Suicidal Thoughts in Flanders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Suicidal Ideation
Suicide Attempt
Multicenter Study
Epidemiological Study
Suicidal Behavior
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 50000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of individuals who are admitted to hospitals or other healthcare institutions, clinic of University Hospital Ghent, A-zorg Aalst, Vitaz Sint-Niklaas, AZ Herentals, AZ Oudenaarde, AZ Sint-Lucas Gent, AZ Sint Vincentius Deinze, AZ Sint Blasius Dendermonde, AZ Jan Palfijn Gent, AZ Alma Eeklo, AZ Groeninge Kortrijk, AZ Oostende, OLV v Lourdes Waregem, AZ Sint Jan Brugge, AZ West Veurne, AZ Sint Lucas Brugge, Jan Yperman ziekenhuis, Sint Andriesziekenhuis Tielt, Sint-Jozefskliniek Izegem, AZ Delta Roeselare, AZ Sint Maria Halle, AZ diest, AZ Klina Brasschaat, AZ Monica Deurne, AZ Sint Maarten Mechelen, AZ Voorkempen Malle, Ziekenhuis Geel, Heilig Hart Lier, Universitair Ziekenhuis Antwerpen, Imeldaziekenhuis Bonheiden, ZSA-UKJA Antwerpen, Sint-Trudo Sint-Truiden, ZOL Genk, Psychiatrisch ziekenhuis Bilzen-Hoeselt.

Brief summary: The objective of this study is to collect data in Flanders on the incidence of suicide attempts and suicidal ideation across various healthcare settings. The study also aims to assess the proportion of individuals who receive adequate aftercare following a suicide attempt and to systematically document the methods and means used in suicidal behavior.

Detailed description: This study involves the registration of the frequency and characteristics of suicidal thoughts and suicide attempts among individuals presenting to healthcare services (including general hospitals, psychiatric hospitals, mobile crisis teams, and general practitioners). Participants will be evaluated using a semi-structured interview: the Guideline for Suicide Care and Evaluation (LOES).

The primary objective is to collect detailed data on individuals with suicidal behavior-including suicidal ideation and suicide attempts-using the LOES instrument. This approach allows for the collection of comprehensive information about suicidal individuals in Flanders and the suicidal processes affecting them.

The LOES comprises two components:

1. Basic Assessment The initial assessment occurs shortly after the individual presents at a healthcare institution. During this interview, an emergency nurse, physician, psychologist, or psychiatrist evaluates the individual's cognitive functioning, judgment, emotional state, observable behavior, potential mental health disorders, history of self-harm or suicidal behavior, social support, level of hopelessness, and willingness to engage in follow-up care. Sociodemographic data and details about the current and any previous suicide attempts are also recorded.

   The goals of this assessment are:
   * To ensure the individual feels heard and taken seriously.
   * To determine the appropriate timing for a more comprehensive risk assessment based on the initial findings.
2. Further Exploration of Suicidality This second phase is conducted by a nurse, psychologist, or psychiatrist. It includes a more in-depth evaluation of the individual's risk factors and treatment needs. Standardized questions cover topics such as suicidal intent, suicidal ideation and concrete planning, motivations for self-harm or suicidal thoughts, ambivalence, experienced life problems, psychiatric history, potential substance use, coping strategies, and care needs of both the individual and their immediate environment.

Based on the data collected through the LOES, a structured and well-supported risk formulation can be established.

Eligibility criteria: Inclusion Criteria:

* Everyone who is admitted alive to the emergency department after a suicide attempt is included. All methods used during the suicide attempt are included. Regarding the method of suicide attempts, a distinction is made between self-injury (hanging, strangulation, drowning, stab and cut wounds, jumping from a height, etc.) and self-poisoning (ingestion of (psycho)pharmaceuticals, drugs, alcohol, chemicals, or other harmful substances).
* Everyone who is admitted with suicidal thoughts

Exclusion Criteria:

* Accidental overdose, e.g., someone taking medication for a medical condition without any intent to harm themselves
* Alcohol intoxication without any intent to harm oneself
* Accidental overdose involving party drugs
* Individuals who were deceased upon arrival at the hospital due to suicide

Primary outcomes:
measure: Baseline Demographic and Socioeconomic Characteristics
timeFrame: Day 1
measure: Baseline Demographic, Socioeconomic and Clinical Admission Characteristics
timeFrame: Day 1
measure: Method of Suicide Attempt Classified by ICD-10 Category
timeFrame: Day 1
measure: Assessment of Current Emotional State (Open-Ended Response)
timeFrame: Day 1
measure: Suicidal Ideation Attributes (Modified SIDAS)
timeFrame: Day 1
measure: Assessment of Suicidal Planning and Intent (Mixed-Methods Interview)
timeFrame: Day 1
measure: History of Suicidal Behavior and Post-Attempt Treatment (Structured Interview)
timeFrame: Day 1
measure: History and Recency of Self-Harming Behavior (Structured Interview)
timeFrame: Day 1
measure: Perceived Social Support and Help-Seeking Behavior (Semi-Structured Interview)
timeFrame: Day 1
measure: Participant's Experience of Hopelessness (Open-Ended Response)
timeFrame: Day 1
measure: Openness to Professional Help When Experiencing Suicidal Thoughts
timeFrame: Day 1
measure: Suicide Intent Severity Assessed by Suicide Intent Scale (SIS)
timeFrame: Day 1
measure: Motives for Suicide Attempt Based on Structured Clinician Classification
timeFrame: Day 1
measure: Sources of Ambivalence Toward Suicide Attempt (Open-Ended Interview Question)
timeFrame: Day 1
measure: Presence and Duration of Stressful or Traumatic Life Events (Clinician-Coded Intake Observation)
timeFrame: Day 1
measure: Substance Use Risk Assessed by CRAFFT Screening Tool
timeFrame: Day 1
measure: History of Mental Health Problems and Prior Treatment (Categorical and Narrative Assessment)
timeFrame: Day 1
measure: Coping Strategies in Response to Stress (Narrative and Structured Clinician Assessment)
timeFrame: Day 1
measure: Perceived Positive and Negative Future Events (Open-Ended Interview Questions)
timeFrame: Day 1
measure: Patient-Reported Care Needs and Expectations (Open-Ended Interview Response)
timeFrame: Day 1
measure: Post-Assessment Care Pathways and Treatment Agreements
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Azorg
city: Antwerpen
country: Belgium
facility: Ziekenhuis aan de Stroom (UKJA)
city: Antwerpen
country: Belgium
facility: Universitair ziekenhuis Antwerpen
city: Bilzen
country: Belgium
facility: Psychiatrisch ziekenhuis Bilzen-Hoeselt
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Brugge
country: Belgium
facility: AZ sint Jan
city: Brugge
country: Belgium
facility: AZ sint Lucas
city: Deinze
country: Belgium
facility: AZ Sint Vincentius
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius
city: Deurne
country: Belgium
facility: AZ Monica
city: Diest
country: Belgium
facility: AZ Diest
city: Eeklo
country: Belgium
facility: AZ Alma
city: Geel
country: Belgium
facility: Ziekenhuis Geel
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Gent
country: Belgium
facility: AZ Jan Palfijn
city: Gent
country: Belgium
facility: AZ Sint-Lucas
city: Halle
country: Belgium
facility: AZ Sint Maria
city: Herentals
country: Belgium
facility: AZ Herentals
city: Ieper
country: Belgium
facility: Jan Yperman ziekenhuis
city: Izegem
country: Belgium
facility: Sint-Jozefskliniek
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Lier
country: Belgium
facility: Heilig Hart Lier
city: Malle
country: Belgium
facility: AZ Voorkempen
city: Mechelen
country: Belgium
facility: AZ Sint Maarten
city: Oostende
country: Belgium
facility: AZ oostende
city: Oudenaarde
country: Belgium
facility: AZ Oudenaarde
city: Roeselare
country: Belgium
facility: AZ Delta
city: Sint-Niklaas
country: Belgium
facility: VITAZ
city: Sint-Truiden
country: Belgium
facility: Sint-Trudo ziekenhuis
city: Tielt
country: Belgium
facility: Sint Andriesziekenhuis
city: Veurne
country: Belgium
facility: AZ West
city: Waregem
country: Belgium
facility: O.L.V. van Lourdes ziekenhuis Waregem
Study officials:
affiliation: University Ghent
name: Gwendolyn Portzky, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vancayseele N, Portzky G, van Heeringen K. Increase in Self-Injury as a Method of Self-Harm in Ghent, Belgium: 1987-2013. PLoS One. 2016 Jun 1;11(6):e0156711. doi: 10.1371/journal.pone.0156711. eCollection 2016.
citation: de Beurs D, Vancayseele N, van Borkulo C, Portzky G, van Heeringen K. The association between motives, perceived problems and current thoughts of self-harm following an episode of self-harm. A network analysis. J Affect Disord. 2018 Nov;240:262-270. doi: 10.1016/j.jad.2018.07.047. Epub 2018 Jul 27.
citation: Vancayseele N, Rotsaert I, Portzky G, van Heeringen K. Medication used in intentional drug overdose in Flanders 2008-2013. PLoS One. 2019 May 2;14(5):e0216317. doi: 10.1371/journal.pone.0216317. eCollection 2019.