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Clinical Trials in Denmark / NCT06025617
Active, not recruiting Not applicable

DISTRESS Trial Functional Disorders - the DISTRESS Trial

NCT06025617 · tracked via the Priya Life Science Denmark tracker
Sponsor
Regionshospitalet Silkeborg
Phase
Not applicable
Started
2019-07-01
Last updated
2026-09-17

Condition(s) studied

Bodily Distress SyndromeFunctional Somatic Disorder

Investigational drug(s) / intervention(s)

Diagnostic evaluation at the Diagnostic Clinic for Functional DisordersDiagnostic as usual

Diagnostic evaluation at the Diagnostic Clinic for Functional Disorders: The intervention consists of being examined at the Diagnostic Clinic for Functional Disorders. If an FSD diagnosis is established, the patient receives feed-back of on the FSD diagnosis and patient education about the condition. Subsequently, the clinic provides guidance to the GP regarding recommended management and treatment options tailored to each individual patient.

Diagnostic as usual: "Diagnostic as usual" consists in being referred to be examined at another existing specialist clinic in the secondary sector, as specified by the patient's GP.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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. Inclusion Criteria: * 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. Exclusion Criteria: * Having another severe chronic disease which explains the reduced level of functioning. * Having been previously referred to or evaluated for FSD at this or another clinic specializing in functional disorders. * Previous diagnosis of FSD. * Alcohol or other substance-dependency or -abuse. * 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. * 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). * Currently pregnant.

Primary outcome measure(s)

  • Healthcare services utilization (i.e. direct costs) — 12 months prior to randomization and 12 months' follow-up
    Comparison of healthcare services utilization (of secondary and tertiary sector care) by the intervention group, compared to the control group. Data shall be drawn from Danish national and regional healthcare service registers.
  • Cost-effectiveness analysis (CEA) (direct and indirect costs) — 12 months prior to randomization and 12 months' follow-up
    Cost-effectiveness analysis (CEA), comparing the intervention and the control group from both a healthcare (direct costs) and a societal perspective (indirect costs) combining data on incremental costs and incremental effects; adjusted for differences in mean utility score and mean costs at baseline (1 year prior to randomization).

Trial sites (1)

FacilityCityRegionStatus
Regionshospitalet Silkeborg Silkeborg Denmark

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Central Processing of Odour Stimuli in Patients With Functional Somatic Disorder, MCS or Post Covid Compared to Healthy Controls Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06025617 on ClinicalTrials.gov ↗ ← All trials in Denmark