- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Brussels Capital
-
Jette, Brussels Capital, Bélgica, 1090
- Vakgroep Huisartsgeneeskunde en Chronische Zorg
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of general practitioners reporting improved diagnostic accuracy following use of the 4DSQ
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hakki Demirkapu, Phd, MD, Vrije Universiteit Brussel
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- EC-2025-187
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Depressão Transtorno de Ansiedade
-
Fondazione Policlinico Universitario Agostino Gemelli...Ainda não está recrutandoCirrose hepática | Hipertensão Portal Não Cirrótica | Hipertensão portal relacionada à cirrose | Elastografia Ultrassônica | Ultrassom com contraste | Porto-sinusoidal Vascular Liver DisorderItália