Status:
ACTIVE_NOT_RECRUITING
DISTRESS Trial Functional Disorders - the DISTRESS Trial
Lead Sponsor:
Regionshospitalet Silkeborg
Collaborating Sponsors:
Aarhus University Hospital
Conditions:
Bodily Distress Syndrome
Functional Somatic Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 Practit...
Detailed Description
Functional Somatic Disorders (FSD) are conditions where patients present with characteristic patterns of physical symptoms, accompanied by impairment or disability. FSD is a clinical diagnosis for whi...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2026
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT06025617
Start Date
June 1 2019
End Date
September 1 2026
Last Update
January 27 2025
Active Locations (1)
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1
Regionshospitalet Silkeborg
Silkeborg, Denmark