Clinical Trial

DISTRESS Trial Functional Disorders - the DISTRESS Trial

Study acronym: DISTRESS
Active, Not Recruiting
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Record status
This record was last updated January 27, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
A Diagnostic Clinic for Functional Somatic Disorders (FSD) has been set up at the outpatient diagnostic center at Regionshospitalet Silkeborg. The objective of the clinic is to support General Practitioners (GPs) by offering early stage diagnostic evaluation of whether a patient has an FSD or the symptoms were caused by another physical illness or mental disorder. As a novelty in this project, Internal Medicine consultants examine the patients for FSD, after having received training in diagnosing FSD by FSD experts. By performing diagnostic evaluation for physical diseases and FSD simultaneously, the investigators believe that the new clinic shall be able to accelerate the establishment of a final diagnosis for these patients who would otherwise likely undergo a protracted diagnostic course involving sequential evaluations at various specialty clinics. The DISTRESS trial is a pragmatic randomized clinical trial which aims to evaluate the Diagnostic Clinic for FSD in terms of clinical cost-effectiveness outcomes.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-08-29.
Status change: Recruiting → Active, Not Recruiting 2025-01-22
Trial Details
NCT Number NCT06025617
Lead Sponsor Regionshospitalet Silkeborg
Collaborators: Aarhus University Hospital
Conditions Bodily Distress Syndrome, Functional Somatic Disorder
Enrollment 290 participants
Start Date 2019-06-01
Primary Completion 2025-12 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2025-01-27