Active — Not RecruitingNot Applicable

DISTRESS Trial Functional Disorders - the DISTRESS Trial

Denmark290 participantsStarted 2019-06-01

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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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.

What they're measuring

Healthcare services utilization (i.e. direct costs)

Timeframe: 12 months prior to randomization and 12 months' follow-up

Cost-effectiveness analysis (CEA) (direct and indirect costs)

Timeframe: 12 months prior to randomization and 12 months' follow-up

Trial details

NCT IDNCT06025617

SponsorRegionshospitalet Silkeborg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12