DISTRESS Trial Functional Disorders - the DISTRESS Trial (DISTRESS)
Bodily Distress Syndrome, Functional Somatic Disorder
About this trial
This is an interventional diagnostic trial for Bodily Distress Syndrome focused on measuring Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome, Somatoform Disorders
Eligibility Criteria
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.
Sites / Locations
- Regionshospitalet SilkeborgRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intervention arm
Control arm
Patients referred by their GP under suspicion of suffering from FSD are randomized to the intervention arm.
Patients referred by their GP under suspicion of suffering from FSD are randomized to "Diagnostic as usual" in the control arm.