Depression Anxiety DisorderNCT07653022
The Value of the Turkish Translation of the Four-Dimensional Symptom Questionnaire for Turkish-speaking Patients With Psychological Complaints and Language Barriers.
A study testing Turkish translation of the Four-Dimensional Symptom Questionnaire in people with Depression Anxiety Disorder, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Our objectives are to determine whether the 4DSQ is valuable for Turkish-speaking patients living in Belgium who face language barriers-meaning they are not fluent in Dutch or French-and have psychological complaints, and to provide better support within the primary healthcare system for general practitioners (GPs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression Anxiety Disorder
- What is being tested?
- Turkish translation of the Four-Dimensional Symptom Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2025to 1 Apr 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We will include GPs who don't speak Turkish.
- Patients must:
- be 18 years or older
- be fluent in Turkish, not in Dutch or French
Who cannot join
- Patients with severe psychiatric disorders requiring specialized care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Vakgroep Huisartsgeneeskunde en Chronische Zorg
Jette, Brussels Capital, 1090
About this study
Our objectives are to determine whether the 4DSQ is valuable for Turkish-speaking patients living in Belgium who face language barriers-meaning they are not fluent in Dutch or French-and have psychological complaints, and to provide better support within the primary healthcare system for general practitioners (GPs).
We will use individual semi-structured interviews with GPs who applied the Turkish 4DSQ to diagnose only Turkish-speaking patients with mental health issues.
Read the detailed description
In Belgium, psychological complaints are common in general practice. Patients present with a wide spectrum of issues, ranging from mild symptoms to severe mental illnesses. According to a study conducted in Flanders in 2024, approximately 22% of the adult general population in Flanders meet the criteria for a mental disorder. This is more than the 15% estimated twenty years ago. As a general practitioner (GP), you understand your patient's background, have a trusted relationship, and serve as a key point of contact.
Clinicians employ a diverse range of models and treatments for patients presenting with mental health concerns. This variation in practice raises important questions about the provision of optimal care. In 1994, Dutch researchers developed a mental health assessment approach specifically designed for use in primary care. This approach involves a multidimensional assessment where patients' symptoms are reported and scored across four key areas: distress, depression, anxiety, and physical symptoms. The assessment is conducted using the Four-Dimensional Symptom Ques- tionnaire (4DSQ) before or between consultations. The resulting score profile across these dimensions helps inform clinical decision-making during the consultation. In a thesis which
completed by a family doctor at KU Leuven University in Belgium between 2014 and 2016, the 4DSQ was identified as a valuable resource for general practitioners in primary care in Belgium.
In medical and psychological care, a language barrier can lead to misunderstandings, incorrect diagnoses, and limited access to appropriate care. Therefore, translations must be not only linguistically accurate but also aligned with how people in a particular community discuss and understand mental health.
The 4DSQ has been translated into multiple languages and is used worldwide in primary care and psychological diagnostics. Currently, it is available on the EMGO website in 17 different languages: Some of them are Dutch, English, French, German, Czech, Greek, Polish, Romanian, Russian, Serbian, Turkish, Urdu (the official national language of Pakistan).
For the two versions, the cutoff scores had to be adjusted to match the Dutch version. Specifically:
In the English version, the cutoff for the highly elevated anxiety score needed to be lowered by one point. In the Polish version, the cutoff for the normal distress score had to be lowered by one point.
A significant Turkish population lives in Belgium. Given varying estimates, it's reasonable to infer that the Turkish community, including both immigrants and their descendants, comprises between 200,000 and 500,000 individuals in Belgium. According to recent studies in Belgium, Turks are among the ethnic groups with the highest antidepressant use.
The 4DSQ was translated into Turkish with the help of a team of general practitioners from Marmara University, Istanbul, and a Dutch-Turkish psychiatrist in the Netherlands. Two separate studies were conducted, and the test was adapted to the culture of the Turkish community. However, how frequently it is used in Turkey or Belgium remains unknown.
Study Aim
The aim of this study is to determine whether the Turkish version of the Four-Dimensional Symptom Questionnaire (4DSQ) is a valuable tool for assessing psychological complaints in Turkish-speaking patients living in Belgium who face language barriers-that is, those who are not proficient in Dutch or French. The goal is to explore whether the use of the 4DSQ in this population can contribute to more accurate clinical evaluations and improve support within the primary healthcare system.
This approach is expected to help minimize the medicalization of psychological symptoms and reduce unnecessary-or potentially harmful-overtreatment with antidepressant medications. Moreover, the use of the 4DSQ may promote broader diagnostic conversations during consultations by incorporating symptom dimensions frequently described by patients themselves, such as distress or stress, even in the absence of a formal depression diagnosis.
Research Question
Does the use of the Turkish version of the 4DSQ in primary care consultations improve the diagnostic accuracy, communication, and treatment quality for Turkish-speaking patients with psychological complaints who face language barriers in Belgium?
Expectations
This study is expected to yield several important outcomes for both patients and healthcare providers, particularly within the context of culturally and linguistically diverse primary care:
- Improved Clinical Understanding by General Practitioners It is anticipated that Belgian GPs will gain a deeper and more structured understanding of the psychological symptoms experienced by Turkish-speaking patients. The 4DSQ enables standardized assessment of distress, depression, anxiety, and somatization, reducing diagnostic errors caused by language barriers.
- Enhanced Doctor-Patient Communication The culturally adapted and linguistically accessible self-report nature of the 4DSQ may improve communication, especially when verbal interaction is limited. Patients may feel more understood and empowered to express their symptoms, potentially leading to more open and honest disclosure.
- Potential Changes in Diagnostic and Treatment Pathways Better symptom profiles obtained through the 4DSQ may lead to more targeted treatments, such as increased psychosocial referrals and decreased unnecessary use of antidepressants, thus reducing the medicalization of stress-related complaints.
- Increased Satisfaction Among Patients and Providers Higher satisfaction is anticipated from both patients and GPs. Patients may feel more acknowledged and taken seriously, while GPs may experience more confidence in clinical decision-making due to the availability of a validated screening tool.
- Support for Culturally Competent Care in Primary Practice Findings may support the broader use of culturally adapted screening tools in routine care, potentially serving as a model for other minority groups and enhancing equitable access to mental healthcare.
- Conditions
- Depression Anxiety Disorder
- Being tested
- Turkish translation of the Four-Dimensional Symptom Questionnaire
- Keywords
- Four-Dimensional Symptom Questionnaire, Qualitative interview study, Language barriers, Depression anxiety disorder, Turkish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish translation of the Four-Dimensional Symptom QuestionnaireDiagnostic test
A qualitative interview study will be conducted, where Belgian general practitioners (GPs) who do not speak Turkish will administer the Turkish version of the 4DSQ to Turkish-speaking patients with psychological complaints and language barriers.
The study will primarily be conducted in the form of two interviews. In the first phase, Belgian general practitioners who do not speak Turkish and wish to participate in the study will be introduced to the study's purpose, plan, and the Turkish version of the 4DSQ. The participating general practitioners will administer the 4DSQ to patients who speak Turkish but do not understand Dutch or French. The participation of at least 10 general practitioners is planned. GPs who applied the 4DSQ to target patients and created the treatment follow-up scheme will be interviewed again.
Interviews will be audio-recorded. The privacy of participants will be ensured by altering data that could identify individuals. After transcription, the recording
| Study group | Role | What they receive |
|---|---|---|
| Interview with GP's who don't speak Turkish. | Active comparator | We will interview with GPs who applied the Turkish 4DSQ to diagnose only Turkish-speaking patients with mental health issues. Receives: Diagnostic Test: Turkish translation of the Four-Dimensional Symptom Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of general practitioners reporting improved diagnostic accuracy following use of the 4DSQ
Number of participating general practitioners who report, during a semi-structured qualitative interview, that the 4DSQ improved their ability to identify and differentiate psychological complaints (e.g., distress, depression, anxiety, or somatization) in Turkish-speaking patients after using the questionnaire in clinical practice.
Measured: After completion of 4DSQ use in at least two Turkish-speaking patients, up to 3 months after enrolment
Number of general practitioners reporting changes in clinical management following use of the 4DSQ
Number of participating general practitioners who report, during a semi-structured qualitative interview, that the 4DSQ influenced their clinical management decisions for Turkish-speaking patients presenting with psychological complaints. Examples include changes in treatment planning, referrals, medication prescribing, or adoption of a watchful waiting approach.
Measured: After completion of 4DSQ use in at least two Turkish-speaking patients, up to 3 months after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hakki Demirkapu, Phd, MD, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653022
- Sponsor's protocol ID
- EC-2025-187
- Status last verified
- Sep 2025
- First submitted
- 11 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of the Turkish Translation of the Four-Dimensional Symptom Questionnaire for Turkish-speaking Patients With Psychological Complaints and Language Barriers.
- ClinicalTrials.gov ID
- NCT07653022
- Acronym / sponsor ID
- EC-2025-187
- Conditions
- Depression Anxiety Disorder
- Keywords
- Four-Dimensional Symptom Questionnaire, Qualitative interview study, Language barriers, Depression anxiety disorder, Turkish
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 17 Jun 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.
Our objectives are to determine whether the 4DSQ is valuable for Turkish-speaking patients living in Belgium who face language barriers-meaning they are not fluent in Dutch or French-and have psychological complaints, and to provide better support within the primary healthcare system for general practitioners (GPs).
We will use individual semi-structured interviews with GPs who applied the Turkish 4DSQ to diagnose only Turkish-speaking patients with mental health issues.
Detailed description
In Belgium, psychological complaints are common in general practice. Patients present with a wide spectrum of issues, ranging from mild symptoms to severe mental illnesses. According to a study conducted in Flanders in 2024, approximately 22% of the adult general population in Flanders meet the criteria for a mental disorder. This is more than the 15% estimated twenty years ago. As a general practitioner (GP), you understand your patient's background, have a trusted relationship, and serve as a key point of contact.
Clinicians employ a diverse range of models and treatments for patients presenting with mental health concerns. This variation in practice raises important questions about the provision of optimal care. In 1994, Dutch researchers developed a mental health assessment approach specifically designed for use in primary care. This approach involves a multidimensional assessment where patients' symptoms are reported and scored across four key areas: distress, depression, anxiety, and physical symptoms. The assessment is conducted using the Four-Dimensional Symptom Ques- tionnaire (4DSQ) before or between consultations. The resulting score profile across these dimensions helps inform clinical decision-making during the consultation. In a thesis which
completed by a family doctor at KU Leuven University in Belgium between 2014 and 2016, the 4DSQ was identified as a valuable resource for general practitioners in primary care in Belgium.
In medical and psychological care, a language barrier can lead to misunderstandings, incorrect diagnoses, and limited access to appropriate care. Therefore, translations must be not only linguistically accurate but also aligned with how people in a particular community discuss and understand mental health.
The 4DSQ has been translated into multiple languages and is used worldwide in primary care and psychological diagnostics. Currently, it is available on the EMGO website in 17 different languages: Some of them are Dutch, English, French, German, Czech, Greek, Polish, Romanian, Russian, Serbian, Turkish, Urdu (the official national language of Pakistan).
For the two versions, the cutoff scores had to be adjusted to match the Dutch version. Specifically:
In the English version, the cutoff for the highly elevated anxiety score needed to be lowered by one point. In the Polish version, the cutoff for the normal distress score had to be lowered by one point.
A significant Turkish population lives in Belgium. Given varying estimates, it's reasonable to infer that the Turkish community, including both immigrants and their descendants, comprises between 200,000 and 500,000 individuals in Belgium. According to recent studies in Belgium, Turks are among the ethnic groups with the highest antidepressant use.
The 4DSQ was translated into Turkish with the help of a team of general practitioners from Marmara University, Istanbul, and a Dutch-Turkish psychiatrist in the Netherlands. Two separate studies were conducted, and the test was adapted to the culture of the Turkish community. However, how frequently it is used in Turkey or Belgium remains unknown.
Study Aim
The aim of this study is to determine whether the Turkish version of the Four-Dimensional Symptom Questionnaire (4DSQ) is a valuable tool for assessing psychological complaints in Turkish-speaking patients living in Belgium who face language barriers-that is, those who are not proficient in Dutch or French. The goal is to explore whether the use of the 4DSQ in this population can contribute to more accurate clinical evaluations and improve support within the primary healthcare system.
This approach is expected to help minimize the medicalization of psychological symptoms and reduce unnecessary-or potentially harmful-overtreatment with antidepressant medications. Moreover, the use of the 4DSQ may promote broader diagnostic conversations during consultations by incorporating symptom dimensions frequently described by patients themselves, such as distress or stress, even in the absence of a formal depression diagnosis.
Research Question
Does the use of the Turkish version of the 4DSQ in primary care consultations improve the diagnostic accuracy, communication, and treatment quality for Turkish-speaking patients with psychological complaints who face language barriers in Belgium?
Expectations
This study is expected to yield several important outcomes for both patients and healthcare providers, particularly within the context of culturally and linguistically diverse primary care:
- Improved Clinical Understanding by General Practitioners It is anticipated that Belgian GPs will gain a deeper and more structured understanding of the psychological symptoms experienced by Turkish-speaking patients. The 4DSQ enables standardized assessment of distress, depression, anxiety, and somatization, reducing diagnostic errors caused by language barriers.
- Enhanced Doctor-Patient Communication The culturally adapted and linguistically accessible self-report nature of the 4DSQ may improve communication, especially when verbal interaction is limited. Patients may feel more understood and empowered to express their symptoms, potentially leading to more open and honest disclosure.
- Potential Changes in Diagnostic and Treatment Pathways Better symptom profiles obtained through the 4DSQ may lead to more targeted treatments, such as increased psychosocial referrals and decreased unnecessary use of antidepressants, thus reducing the medicalization of stress-related complaints.
- Increased Satisfaction Among Patients and Providers Higher satisfaction is anticipated from both patients and GPs. Patients may feel more acknowledged and taken seriously, while GPs may experience more confidence in clinical decision-making due to the availability of a validated screening tool.
- Support for Culturally Competent Care in Primary Practice Findings may support the broader use of culturally adapted screening tools in routine care, potentially serving as a model for other minority groups and enhancing equitable access to mental healthcare.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interview with GP's who don't speak Turkish. | Active comparator | Diagnostic Test: Turkish translation of the Four-Dimensional Symptom QuestionnaireWe will interview with GPs who applied the Turkish 4DSQ to diagnose only Turkish-speaking patients with mental health issues. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- We will include GPs who don't speak Turkish.
- be 18 years or older
- be fluent in Turkish, not in Dutch or French
Key exclusion criteria (1 listed)
- Patients with severe psychiatric disorders requiring specialized care
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 |
|---|---|---|
| Turkish translation of the Four-Dimensional Symptom QuestionnaireA qualitative interview study will be conducted, where Belgian general practitioners (GPs) who do not speak Turkish will administer the Turkish version of the 4DSQ to Turkish-speaking patients with psychological complaints and language barriers. The study will primarily be conducted in the form of two interviews. In the first phase, Belgian general practitioners who do not speak Turkish and wish to participate in the study will be introduced to the study's purpose, plan, and the Turkish version of the 4DSQ. The participating general practitioners will administer the 4DSQ to patients who speak Turkish but do not understand Dutch or French. The participation of at least 10 general practitioners is planned. GPs who applied the 4DSQ to target patients and created the treatment follow-up scheme will be interviewed again. Interviews will be audio-recorded. The privacy of participants will be ensured by altering data that could identify individuals. After transcription, the recording | Diagnostic test | Interview with GP's who don't speak Turkish. |
Primary outcome
Number of general practitioners reporting improved diagnostic accuracy following use of the 4DSQ
Time frame: After completion of 4DSQ use in at least two Turkish-speaking patients, up to 3 months after enrolment
Number of participating general practitioners who report, during a semi-structured qualitative interview, that the 4DSQ improved their ability to identify and differentiate psychological complaints (e.g., distress, depression, anxiety, or somatization) in Turkish-speaking patients after using the questionnaire in clinical practice.
Number of general practitioners reporting changes in clinical management following use of the 4DSQ
Time frame: After completion of 4DSQ use in at least two Turkish-speaking patients, up to 3 months after enrolment
Number of participating general practitioners who report, during a semi-structured qualitative interview, that the 4DSQ influenced their clinical management decisions for Turkish-speaking patients presenting with psychological complaints. Examples include changes in treatment planning, referrals, medication prescribing, or adoption of a watchful waiting approach.
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 17 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Hakki Demirkapu, Phd, MD principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turkish translation of the Four-Dimensional Symptom Questionnaire in people with Depression Anxiety Disorder, run by Universitair Ziekenhuis Brussel at 1 site 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 4 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: enrolling by invitation, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 general practitioners reporting improved diagnostic accuracy following use of the 4DSQ (time frame: After completion of 4DSQ use in at least two Turkish-speaking patients, up to 3 months after enrolment). The study lists 2 primary outcomes in all. 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 17 Jun 2026.