NCT07653022

Brief 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). We will use individual semi-structured interviews with GPs who applied the Turkish 4DSQ to diagnose only Turkish-speaking patients with mental health issues.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Oct 2025Apr 2027

Study Start

First participant enrolled

October 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

June 17, 2026

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

May 11, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

Four-Dimensional Symptom QuestionnaireQualitative interview studyLanguage barriersDepression anxiety disorderTurkish

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    After completion of 4DSQ use in at least two Turkish-speaking patients, up to 3 months after enrolment

Study Arms (1)

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.

Diagnostic Test: Turkish translation of the Four-Dimensional Symptom Questionnaire

Interventions

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

Interview with GP's who don't speak Turkish.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with severe psychiatric disorders requiring specialized care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vakgroep Huisartsgeneeskunde en Chronische Zorg

Jette, Brussels Capital, 1090, Belgium

Location

Study Officials

  • Hakki Demirkapu, Phd, MD

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2026

First Posted

June 17, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

June 17, 2026

Record last verified: 2025-09

Locations