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Can a One-Stop clinic solve the mystery of functional disorders?

NCT ID NCT06025617

Diagnosis Sponsor: Regionshospitalet Silkeborg Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Functional somatic disorders cause persistent physical symptoms that doctors cannot explain by other diseases. The DISTRESS trial evaluates a new clinic where internal medicine doctors, trained to recognize these disorders, examine patients and provide guidance to their general practitioners. The trial compares this approach with usual care to see if it leads to faster diagnosis and lower healthcare costs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A new diagnostic clinic where internal medicine doctors evaluate patients for functional somatic disorders
What this could lead to
If the clinic works, it could give people with functional somatic disorders a faster diagnosis and reduce the need for repeated specialist visits.
What could go wrong
The trial measures costs and healthcare use, not whether patients feel better. A faster diagnosis may not lead to better outcomes, and the clinic's approach may not work in other settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

290 people

The number who actually took part.

Started

Jul 2019

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fibromyalgia irritable bowel syndrome myalgic encephalomeyelitis/chronic fatigue syndrome somatoform disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bodily distress syndrome Functional somatic disorder

Contacts and locations

Locations

  • Regionshospitalet Silkeborg

    Silkeborg, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.