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 range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Healthcare services utilization (i.e. direct costs)
Timeframe: 12 months prior to randomization and 12 months' follow-up
2
Cost-effectiveness analysis (CEA) (direct and indirect costs)
Timeframe: 12 months prior to randomization and 12 months' follow-up