- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07653022
The Value of the Turkish Translation of the Four-Dimensional Symptom Questionnaire for Turkish-speaking Patients With Psychological Complaints and Language Barriers.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Brussels Capital
-
Jette, Brussels Capital, Belgium, 1090
- Vakgroep Huisartsgeneeskunde en Chronische Zorg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with severe psychiatric disorders requiring specialized care
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Interview with GP's who don't speak Turkish.
We will interview with GPs who applied the Turkish 4DSQ to diagnose only Turkish-speaking patients with mental health issues.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
After completion of 4DSQ use in at least two Turkish-speaking patients, up to 3 months after enrolment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hakki Demirkapu, Phd, MD, Vrije Universiteit Brussel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EC-2025-187
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression Anxiety Disorder
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
UCLH/UCL Joint Research OfficeMedical Research Council; Camden and Islington NHS Trust; Central and North West...RecruitingAnxiety Disorders | Anxiety | Anxiety Depression | CBT | Anxiety Disorders and Symptoms | Anxiety Generalized | Generalised Anxiety Disorder | Anxiety Disorder; Mixed With Depression (Mild) | Anxiety Disorder GeneralizedUnited Kingdom
-
University College, LondonEnrolling by invitationDepression Anxiety Disorder | Depression - Major Depressive DisorderUnited Kingdom
-
University Hospital, Strasbourg, FranceRecruitingDepression Anxiety DisorderFrance
-
Fondazione Policlinico Universitario Agostino Gemelli...Completed
-
University of California, IrvineActive, not recruiting
-
Universitat Jaume IHospital Universitari Mutua TerrassaNot yet recruitingAnxiety Disorders | Depression Anxiety Disorder | Emotional Disorders | Depression DisordersSpain
-
Region StockholmKarolinska InstitutetEnrolling by invitationGeneralized Anxiety Disorder | Depression NOSSweden
-
Cairo UniversityCompletedDepression Anxiety Disorder | Physical DisordersEgypt
-
Mazra Mental Health CenterThe Academic College of Tel-Aviv YaffoUnknown
Clinical Trials on Turkish translation of the Four-Dimensional Symptom Questionnaire
-
Istanbul Saglik Bilimleri UniversityNot yet recruitingRespiratory Insufficiency | Chronic Respiratory FailureTurkey (Türkiye)
-
Hürriyet YılmazMedipol UniversityCompletedAdolescent Idiopathic Scoliosis | Health Related Quality of LifeTurkey
-
Bandırma Onyedi Eylül UniversityEnrolling by invitationParkinson Disease | Validation Studies | DexterityTurkey
-
Istanbul UniversityCompletedChronic Pain | FibromyalgiaTurkey
-
Mutah UniversityCompletedOveractive BladderJordan
-
Istanbul Medeniyet UniversityCompletedParkinson Disease | Falls | Scale Reliability ValidityTurkey (Türkiye)
-
Bezmialem Vakif UniversityCompletedSurgery; Maternal, Uterus or Pelvic Organs, Affecting FetusTurkey (Türkiye)
-
Memorial Sloan Kettering Cancer CenterCompletedLymphedema | Ovarian Cancer | Vaginal Cancer | Uterine CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingOropharyngeal Cancer | Malignant Neoplasms of Lip Oral Cavity and PharynxUnited States
-
University of Campania "Luigi Vanvitelli"CompletedQuality of Life | Rhinitis, Allergic | Child, Only | Nasal Allergy | Allergy Pollen | Nasal, Cytology | Mometasone AllergyItaly