NCT06025617Active, not recruiting
DISTRESS Trial Functional Disorders - the DISTRESS Trial
Comprehensive Evaluation of a New Diagnostic Clinic for Functional Disorders - the DISTRESS Trial
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 290 (actual)
- First submitted
- 7 Aug 2023
- Start date
- 1 Jul 2019
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Regionshospitalet Silkeborg
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06025617
What you commit to
- Study type: Interventional
- Participants enrolled: 290
- From 1 Jul 2019 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having been previously referred to or evaluated for FSD at this or another clinic specializing in functional disorders.
- Previous diagnosis of FSD.
- Current or prior diagnosis of psychosis (ICD10 F2x diagnosis), bipolar affective disorder (ICD10 F31.x diagnosis) or depression with psychotic symptoms (ICD10 F32.3 or F33.3 diagnosis).
Other illness
- Having another severe chronic disease which explains the reduced level of functioning.
- Emergent psychiatric illness or emergent elevated risk of harm to self or others requiring psychiatric evaluation for possible need of acute or sub-acute psychiatric hospitalization.
Other
- Alcohol or other substance-dependency or -abuse.
- Currently pregnant.
Who the study is looking for
- Being referred to the clinic by their GP due to symptoms consistent with a possible diagnosis of moderate or severe FSD.
- Symptoms having been present for at least 6 months and no more than 3 years.
- Having undergone at least 2 diagnostic evaluations (e.g. imaging studies or specialist evaluations) at physical specialty clinics or hospitals in the past year.
- Age 18-60.
- Being of ethnic western cultural upbringing.
- Understands and speaks Danish fluently.
Criteria the registry did not label
- Study population:
- Participants were drawn from the population of the Central Denmark Region. To be considered for inclusion, patients had to be referred by their GP.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Regionshospitalet Silkeborg Coordinator of this site? Confirm its status | Silkeborg | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.