AzTrials
AzTrials

Suicidal IdeationBC-03869NCT07021404

The Epidemiology of Suicide Attempts and Suicidal Thoughts in Flanders

An observational study of Suicidal Ideation and Suicide Attempt, run by University Hospital, Ghent at 33 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
Semi-structured interview (Guideline for Suicide care and Evaluation =LOES)
How many people
50,000 participants
Where
33 sitesBelgium
Study dates
31 Dec 2006to 31 Mar 2033
How long will I take part?
1 Day
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: 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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

33 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nikita Vancayseele, Msc contact

+32 (0)9 332 07 75

nikita.vancayseele@ugent.be

Eva De Jaegere, Msc contact

+32 (0)9 332 07 75

eva.dejaegere@ugent.be

33 sites in 1 country

Belgium33 sites, 32 recruiting

  • Azorg

    Aalst, 9300

    Dries Van der schueren, +32 (0)53 72 41 11, dries.van.der.schueren@olvz-aalst.be

    Charles Du Four, MD

    Recruiting

  • Ziekenhuis aan de Stroom (UKJA)

    Antwerp, 2020

    Catherine Klockaerts, MD, +32 (0)3 280 49 00, catherine.klockaerts@zas.be

    Dirk van West, MD

    Recruiting

  • Universitair ziekenhuis Antwerpen

    Antwerp, 2650

    Filip Van Den Eede, 032 (0)3 821 49 11, filip.vandeneede@uza.be

    Filip Van Den Eede, MD

    Recruiting

  • Psychiatrisch ziekenhuis Bilzen-Hoeselt

    Bilzen, 3740

    Sabine Brocatus, +32 (0)89 50 91 11, sabine.brocatus@zorggroepmyna.be

    Tine Jaspers, MD

    Recruiting

  • Imeldaziekenhuis

    Bonheiden, 2820

    Micha Teuchie, +32 (0)15 50 60 05, micha.teuchie@imelda.be

    An Koeck, MD

    Recruiting

  • AZ Klina

    Brasschaat, 2930

    Heidi Wouters, +32 (0)3 298 10 99, heidi.wouters@klina.be

    J Martens, MD

    Recruiting

  • AZ sint Jan

    Bruges, 8000

    Jan Debaene, +32 (0)50 47 05 30, jan.debaene@azsintjan.be

    Jurgen De Fruyt, MD

    Recruiting

  • AZ sint Lucas

    Bruges, 8310

    Marleen Vincke, +32 (0)50 36 52 15, TSP@stlucas.be

    Thomas Santy, MD

    Recruiting

  • AZ Sint Vincentius

    Deinze, 9800

    Orphélie Lievens, +32 (0) 9 387 73 96, orphelie.lievens@mijnziekenhuis.be

    Sofie Houthoofd, MD

    Recruiting

  • AZ Sint Blasius

    Dendermonde, 9200

    Katrien Goossens, +32 (0)52 25 28 66, katrien.goossens@azstblasius.be

    Katrien Van Laeken, MD

    Recruiting

  • AZ Monica

    Deurne, 2100

    Frederik Somers, +32 (0)3 240 22 59, frederik.somers@azmonica.be

    Paul Descheemaeker, MD

    Recruiting

  • AZ Diest

    Diest, 3290

    Anne-Sophie Weckx, +32 (0)13 35 41 18, anne-sophie.weckx@azdiest.be

    Wim Simons, MD

    Recruiting

  • AZ Alma

    Eeklo, 9900

    Marc Van der Weyde, +32 (0)9 310 06 47

    André Orban, MD

    Recruiting

  • Ziekenhuis Geel

    Geel, 2440

    Ann Van Lommel, +32 (0)14 57 71 23, an.vanlommel@ziekenhuisgeel.be

    Francis Somvile, MD

    Recruiting

  • Ziekenhuis Oost Limburg

    Genk, 3600

    Sabine Keymis, +32 (0)89 50 60 10, sabine.keymis@zol.be

    Rika Vandevelde, MD

    Recruiting

  • AZ Jan Palfijn

    Ghent, 9000

    Sarah Fraeyman, +32 (0)9 224 71 11

    Guido Sieben, MD

    Recruiting

  • AZ Sint-Lucas

    Ghent, 9000

    Tania Coppens, +32 (0/9 224 56 47, tania.coppens@azstlucas.be

    Koen Willems, MD

    Recruiting

  • AZ Sint Maria

    Halle, 1500

    Valérie Demol, +32 (0)2 363 65 41, v.demol@sintmaria.be

    Bernard Raveschot, MD

    Recruiting

  • AZ Herentals

    Herentals, 2200

    Leny Scherlippens, +32 (0)14 24 64 66, leny.scherlippens@azherentals.be

    Luc Belmans, MD

    Recruiting

  • Jan Yperman ziekenhuis

    Ieper, 8900

    Sien Verdru, +32 (0)57 35 67 22, sien.verdru@yperman.net

    Stefan Van Hooreweghe, MD

    Recruiting

  • Sint-Jozefskliniek

    Izegem, 8770

    An Vanderjeught, +32 (0)51 33 41 11, an.vanderjeught@sjki.be

    Luc Grouwels, MD

    Recruiting

  • AZ Groeninge

    Kortrijk, 8500

    Heidi Lepouttre, +32 (0)56 63 69 11

    Koen Titeca, MD

    Recruiting

  • Heilig Hart Lier

    Lier, 2500

    Elisabeth Segers, +32 (0)3 491 31 88, elisabeth.segers@heilighartlier.be

    Filip Auwerkerken, MD

    Recruiting

  • AZ Voorkempen

    Malle, 2390

    Giselle Reyes, +32 (0)3 380 24 84, giselle.reyes@emmaus.be

    Dirk Peeters, MD

    Recruiting

  • AZ Sint Maarten

    Mechelen, 2800

    Sigrid Aerts, +32 (0)15 89 15 03, sigrid.aerts2@emmaus.be

    Isabelle Van Hecke, MD

    Recruiting

  • AZ oostende

    Ostend, 8400

    An Decorte, +32 (0)59 41 61 90, adecorte@azdamiaan.be

    J. Loyens, MD

    Recruiting

  • AZ Oudenaarde

    Oudenaarde, 9700

    Marissa De Meester, +32 (0)55 33 61 11, marissa.demeester@azoudenaarde.be

    Chris Eekchout, MD

    Recruiting

  • AZ Delta

    Roeselare, 8800

    Ingrid Vermeulen, +32 (0)51 23 81 30, ingrid.vermeulen@azdelta.be

    M. Vandewalle, MD

    Recruiting

  • VITAZ

    Sint-Niklaas, 9100

    Active, not recruiting

  • Sint-Trudo ziekenhuis

    Sint-Truiden, 3800

    Sofie Melotte, +32 (0)11 69 91 52, sofie.melotte@stzh.be

    Henri De Vooght, MD

    Recruiting

  • Sint Andriesziekenhuis

    Tielt, 8700

    Katty De Rammelaere, +32 (0)51 42 50 70, katty.de.rammelaere@sintandriestielt.be

    Jozef Verhamme, MD

    Recruiting

  • AZ West

    Veurne, 8630

    Emiel Van Den Eynden, +32 (0)58 33 32 36, emiel.vandeneynden@azwest.be

    Piet Kindts, MD

    Recruiting

  • O.L.V. van Lourdes ziekenhuis Waregem

    Waregem, 8790

    Freya Bernaert, +(32) 56 62 30 70, freya.bernaert@ziekenhuiswaregem.be

    Pieterjan Callens, MD

    Recruiting

Other trials in Belgium

About this study

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.

Read the 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.
  1. 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.

Being tested
Semi-structured interview (Guideline for Suicide care and Evaluation =LOES)
Medical subject headings
Suicidal Ideation, Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semi-structured interview (Guideline for Suicide care and Evaluation =LOES)Other

    A semi-structured interview is utilized in general hospitals and other healthcare institutions by clinicians and nurses as part of the psychosocial assessment, with the aim of collecting standardized data on episodes of self-harm and individuals experiencing suicidal ideation.

    The interview consists of two parts:

    Part 1 is administered shortly after admission to the healthcare facility due to an episode of self-harm or reported suicidal thoughts. It is conducted by a trained nurse or psychologist. This section collects demographic information, characteristics of the self-harm episode, history of self-harm behavior, perceived social support, level of hopelessness, and current suicidal ideation.

    Part 2 focuses on a more in-depth exploration of the individual's psychological state. It assesses underlying motives for the self-harm or suicidal thoughts, perceived personal and interpersonal problems, and current and current thoughts of self-harm.

Study groups in NCT07021404
Study groupRoleWhat they receive
Individuals who presented with suïcidale behavior to Hospitals and other healthcare institutionsNot described
Receives: Other: Semi-structured interview (Guideline for Suicide care and Evaluation =LOES)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline Demographic and Socioeconomic Characteristics

    Sociodemographic information will be collected via standardized intake forms during the initial assessment interview. The following variables will be recorded:

    • Date of birth (continuous, in DD/MM/YYYY format)
    • Gender (Male / Female / X)
    • Marital status (Unmarried / Officially cohabitating / Married / Divorced / Widowed)
    • Housing situation (Alone / Not alone)
    • Presence of children (Yes / No)
    • Economic activity status (Economically active / Unemployed / Economically inactive)
    • If economically inactive: Pupil or student / Disability due to physical or psychological problems / Retirement / Other (specify) Profession (open text, if applicable)
    • School situation (if student):
    • Primary education
    • Secondary education (ASO / TSO / BSO / KSO / BuSO)
    • Higher education or university
    • Other (specify) All responses will be recorded and coded for analysis. Categorical variables will be summarized using frequency and percentage. Open-ended responses will be described narratively

    Measured: Day 1

  2. Baseline Demographic, Socioeconomic and Clinical Admission Characteristics

    Additional personal and contextual characteristics will be collected during the initial assessment interview. These include:

    Pregnancy status (Yes / No)

    Country of birth of the participant, their mother, and their father (Belgium / Other - specify)

    Current medication: Open-ended question regarding all prescribed or self-used medications at time of intake.

    Reason for admission (Suicidal thoughts / Suicide attempt)

    All categorical variables will be recorded using predefined categories. Open-text fields (e.g., country of birth, medication list) will be thematically categorized post-hoc where applicable. These variables are used to describe the population and examine their relationship with clinical outcomes.

    Measured: Day 1

  3. Method of Suicide Attempt Classified by ICD-10 Category

    The method of suicide attempt will be assessed through a semi-structured interview and classified according to the relevant ICD-10 codes for intentional self-harm (e.g., X60-X84). Each participant's attempt will be categorized based on the specific method used (e.g., poisoning, cutting, jumping, hanging), as defined by ICD-10 classification.

    Measured: Day 1

  4. Assessment of Current Emotional State (Open-Ended Response)

    Participants will be asked the open-ended question:

    "How are you feeling right now?" Responses will be collected verbatim during a clinical interview. A qualitative content or thematic analysis will be performed to identify and categorize emotional states (e.g., anxious, sad, calm, angry). The number and percentage of participants reporting each emotional category will be reported.

    Measured: Day 1

  5. Suicidal Ideation Attributes (Modified SIDAS)

    A modified version of the Suicidal Ideation Attributes Scale (SIDAS) will be used to assess the presence and characteristics of suicidal ideation in the past month. The following six items will be included:

    • Current suicidal thoughts: Response: Yes / No.
    • Frequency of suicidal thoughts in the past month
    • Duration of suicidal thoughts
    • Perceived control over suicidal thoughts
    • Emotional suffering due to suicidal thoughts
    • Functional interference (e.g. with work or household tasks)
    • Proximity to a suicide attempt in the past month (only asked if ideation present, not in case of actual attempt).

    This version retains the conceptual dimensions of the original SIDAS but uses predefined categorical response scales instead of numerical ratings. Results will be analyzed using frequency distributions and, where appropriate, ordinal scales. This adapted version allows for structured yet clinically nuanced evaluation of suicidal ideation during intake.

    Measured: Day 1

  6. Assessment of Suicidal Planning and Intent (Mixed-Methods Interview)

    Suicidal planning and intent will be assessed through a structured set of questions combining categorical responses and open-ended fields. The following domains will be evaluated:

    Presence of a current suicide plan (categorized as: no thoughts, thoughts without plan, detailed plan)

    Method(s) considered (open-ended response)

    Availability of method (Yes/No)

    Degree of preparation (No preparation, Minimal preparation, Extensive preparation)

    Timing and delay of planned action (open-ended response)

    Categorical data will be analyzed descriptively (counts and percentages per category). Open-ended responses will undergo thematic analysis to identify patterns in methods considered and perceived urgency or control over suicidal intent.

    Measured: Day 1

  7. History of Suicidal Behavior and Post-Attempt Treatment (Structured Interview)

    Participants will be asked a structured set of questions to assess the history of suicidal behavior and care received following previous suicide attempts. The following aspects will be recorded:

    Number of lifetime suicide attempts (0, 1, 2, 3, ≥4)

    Time since last attempt (≤6 months, 6-12 months, >12 months)

    Psychological treatment received after attempt (Yes/No)

    Satisfaction with treatment (Yes/No)

    Type of provider or setting (e.g., psychiatrist, school guidance center, residential care, mental health center, other)

    Whether the attempt required medical treatment (Yes/No) and location (e.g., hospital, general practitioner, other)

    Method used in previous attempt(s) (open-ended)

    Categorical data will be summarized using frequencies and percentages. Open-ended responses on method used will be analyzed qualitatively and grouped by ICD-10 method category (e.g., poisoning, cutting, jumping).

    Measured: Day 1

  8. History and Recency of Self-Harming Behavior (Structured Interview)

    Participants will be asked whether they have ever deliberately hurt or injured themselves (Yes/No). If the response is Yes, they will be asked to indicate when they last engaged in self-harming behavior:

    < 6 months ago > 6 months ago

    Responses will be recorded categorically to assess lifetime presence and recency of non-suicidal self-injury (NSSI) or deliberate self-harm.

    Measured: Day 1

  9. Perceived Social Support and Help-Seeking Behavior (Semi-Structured Interview)

    Social support will be assessed using a semi-structured interview consisting of both categorical and open-ended questions, focusing on:

    Perceived emotional support: "Do you feel there are people who care about you?" (Yes/No)

    Identified source(s) of support: Open-ended response if Yes

    Availability of support when struggling: (Not inclined to seek support / No / Yes)

    Identified support figure: Open-ended response if Yes

    Actual help-seeking behavior: (No / Sometimes / Yes)

    Open-ended responses (e.g., to whom the participant turns) will be categorized using inductive thematic coding. Categorical responses will be summarized as frequencies and proportions.

    Measured: Day 1

  10. Participant's Experience of Hopelessness (Open-Ended Response)

    Participants will be asked the following open-ended questions:

    "Do you feel completely stuck, as if there is no way out?" "Do you feel hopeless, like there's no way out of your situation?" "Is there anything that might help you get through this period?" Responses will be collected in written form. Qualitative analysis (e.g., thematic analysis or content coding) will be used to identify recurring expressions of hopelessness or related emotional states. Results will be reported as the number and percentage of participants expressing each identified theme.

    Measured: Day 1

  11. Openness to Professional Help When Experiencing Suicidal Thoughts

    Participants will be asked about their willingness to engage in professional help when struggling with suicidal thoughts. The question is phrased as:

    "When struggling with suicidal thoughts, it is recommended to get professional help. Would you be open to have a conversation with [healthcare provider] to gain more insight into the things you are struggling with and possible next steps?"

    Response options are:

    • Does not want professional help
    • Neutral
    • Is open to professional help

    Responses will be recorded categorically and reported as frequencies and proportions across the three levels.

    Measured: Day 1

  12. Suicide Intent Severity Assessed by Suicide Intent Scale (SIS)

    The severity of intent during the most recent suicide attempt will be assessed using the Suicide Intent Scale (SIS). The SIS is a 8-item clinician-administered scale evaluating objective circumstances and subjective expectations associated with the attempt.

    Each item is scored from 0 to 2 (range total score: 0-16), with higher scores indicating greater suicidal intent.

    Scores will be reported as continuous outcomes (mean, SD), and optionally categorized (e.g., low intent: ≤5; high: >6).

    Measured: Day 1

  13. Motives for Suicide Attempt Based on Structured Clinician Classification

    Motives for the suicidal behavior will first be explored through an open-ended question:

    "What motives did you have for your suicide attempt / suicidal thoughts?"

    Based on the participant's narrative, the clinician will categorize the motives using a predefined set of thematic categories:

    • Internal conflict (e.g., emotional overwhelm, self-punishment, feeling of failure)
    • Interpersonal motives (e.g., desire to be heard, influence others, show love, revenge)
    • Death wish
    • Magical thinking (e.g., rebirth, reunion with deceased)

    Multiple categories may be selected per participant. Open-text responses will be retained for qualitative analysis; category selections will be summarized as frequencies and proportions.

    Measured: Day 1

  14. Sources of Ambivalence Toward Suicide Attempt (Open-Ended Interview Question)

    Participants will be asked the open-ended question:

    "What is currently stopping you from attempting suicide?"

    Responses will be documented verbatim. No predefined answer categories will be provided. The data will be used for qualitative analysis of protective factors, barriers, or ambivalent thoughts associated with suicidal ideation or behavior.

    Measured: Day 1

  15. Presence and Duration of Stressful or Traumatic Life Events (Clinician-Coded Intake Observation)

    During the assessment, clinicians will code the presence and estimated duration of any significant life events or psychosocial stressors spontaneously reported by the participant, based on a predefined list of known suicide-related risk factors. These include:

    • Health-related: psychiatric symptoms, physical illness, disability
    • Loss-related: death or illness of a significant person, suicide or suicide attempt of a significant other
    • Trauma: abuse (physical/emotional/sexual), neglect, assault
    • Social/relational: problems with parents, children, partner, friends, bullying
    • Environmental stressors: financial, housing, work/school, legal, identity-related problems

    Each event is coded by the clinician if mentioned, and the duration of suffering related to each event is estimated using a 3-point scale:

    1. = weeks
    2. = months
    3. = years

    Measured: Day 1

  16. Substance Use Risk Assessed by CRAFFT Screening Tool

    Substance use risk will be assessed using the CRAFFT Screening Interview, a validated 6-item questionnaire designed to identify risky substance use behaviors among adolescents and young adults. Each item is scored 0 (No) or 1 (Yes), resulting in a total score ranging from 0 to 6. A score of ≥2 indicates high risk of problematic substance use.

    Measured: Day 1

  17. History of Mental Health Problems and Prior Treatment (Categorical and Narrative Assessment)

    Participants will be asked whether they have experienced previous mental health problems and whether they sought or received professional treatment. Responses will be recorded using the following categories:

    • No previous mental health problems
    • Yes, previous mental health problems but no treatment
    • Yes, previous mental health problems and received treatment

    For those indicating previous problems, clinicians will document:

    Nature of past mental health issues (open-ended) Type of treatment received (e.g., psychologist, psychiatrist, residential care) and experience with care (open-ended) Whether a formal psychiatric diagnosis was given (open-ended)

    Open text responses will be used for qualitative description and may be thematically coded if relevant to the analysis.

    Measured: Day 1

  18. Coping Strategies in Response to Stress (Narrative and Structured Clinician Assessment)

    Participants will be asked an open-ended question exploring how they typically deal with stress and difficult emotions:

    "How do you deal with problems in general? What do you do when you are worried or upset? What helps you keep going?"

    The clinician will document the participant's narrative response and will also indicate the presence or absence of specific coping behaviors based on a predefined checklist:

    • Talks to someone about it
    • Blames self for being in trouble
    • Gets angry
    • Withdraws/stays in room
    • Reflects on previous coping experiences
    • Uses alcohol or drugs
    • Avoids thinking about worries
    • Tries to sort things out Multiple behaviors can be selected per participant.

    Measured: Day 1

  19. Perceived Positive and Negative Future Events (Open-Ended Interview Questions)

    Participants will be asked two open-ended questions to explore their short-term future outlook:

    "Are there any positive things or events in the near future that could affect your suicidal thoughts?"

    "Are there any negative things or events in the near future that could affect your suicidal thoughts?"

    Responses will be documented verbatim. No predefined response categories are used. Responses will provide insight into the participant's subjective experience of hope, anticipatory stress, or protective/risk factors linked to future-oriented thinking.

    Measured: Day 1

  20. Patient-Reported Care Needs and Expectations (Open-Ended Interview Response)

    Participants will be asked open-ended questions regarding their perceived care needs and expectations for support.

    Formal Care Setting: The participant's responses will be categorized into care delivery modes such as ambulatory care, residential care, general practitioner (GP) involvement.

    Content of Care: The narrative responses will be analyzed for themes related to the nature of care needed, including but not limited to psychological support (individual or group therapy), practical assistance, need for rest or stabilization.

    Responses will be documented verbatim and later coded using thematic analysis.

    Measured: Day 1

  21. Post-Assessment Care Pathways and Treatment Agreements

    Following the clinical intake, the treating clinician will document the planned care pathway for the participant by selecting one or more of the following options:

    No further treatment

    • Discharge (advised) (e.g., returning home)
    • Discharge (counter-advised) (e.g., patient runs away)
    • Return to another facility (e.g., detention unit, sheltered housing, medical pedagogical institution)

    Outpatient treatment (e.g., psychotherapy)

    Inpatient treatment

    • Somatic unit
    • Emergency psychiatry
    • Child/adolescent psychiatric crisis unit
    • Child/adolescent psychiatric unit
    • Psychiatric Ward General Hospital (PAAZ)
    • Psychiatric Hospital (PZ) / Psychiatric Care Home (PVT)
    • Other settings (specify): ____________________________

    In addition, any concrete treatment agreements made with the participant will be documented in free text. Monitoring these aspects is essential for evaluating care continuity, adherence to treatment plans, and subsequent clinical outcomes.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2025
  2. Study start31 Dec 2006
  3. Primary completion31 Mar 2033 (estimated)
  4. Study completion31 Mar 2033 (estimated)

Resources

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 only
Time perspective
Prospective
Enrolment
50,000 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07021404
Sponsor's protocol ID
BC-03869
Acronym
BC-03869
Status last verified
Jun 2025
First submitted
17 Mar 2025
Last updated
15 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The investigators have decided not to share the IDP collected throughout the trial due to concerns over participant privacy and data confidentiality. Despite efforts to anonymize the data, there remains a risk that sensitive personal information could be inadvertently disclosed.

Publications

  • 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.

    PubMed 27249421

  • 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.

    PubMed 30086470

  • 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.

    PubMed 31048918

Questions about this trial

What is this clinical trial studying?

An observational study of Suicidal Ideation and Suicide Attempt, run by University Hospital, Ghent at 33 sites in Belgium.

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 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 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Belgium. 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 Nikita Vancayseele, Msc (+32 (0)9 332 07 75, nikita.vancayseele@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline Demographic and Socioeconomic Characteristics (time frame: Day 1). The study lists 21 primary outcomes in all. 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 NCT07021404, which also lists 3 linked publications.

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 15 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in