Bodily Distress SyndromeDISTRESSNCT06025617
DISTRESS Trial Functional Disorders - the DISTRESS Trial
A study testing Diagnostic evaluation at the Diagnostic Clinic for Functional Disorders and Diagnostic as usual in people with Bodily Distress Syndrome and Functional Somatic Disorder, run by Regionshospitalet Silkeborg at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bodily Distress Syndrome, Functional Somatic Disorder
- What is being tested?
- Diagnostic evaluation at the Diagnostic Clinic for Functional Disorders and Diagnostic as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2019to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Evaluation of a New Diagnostic Clinic for Functional Disorders - the DISTRESS Trial
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.
Read the 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 which no clinical or paraclinical tests at present have been found useable for establishing the diagnosis. The disorders range from mild and transient to severe, chronic and disabling, and are common in all medical settings, both in primary and secondary care. FSD is costly for society due to high health care use, and the reduction of patients' labor market participation. Arguably, insufficient diagnostic availability is part of the reason some patients develop more severe, chronic and disabling FSD. The Diagnostic Clinic for FSD was set up at Regionshospitalet to alleviate this diagnostic need in the secondary care setting.
The DISTRESS trial is a pragmatic randomized clinical trial. After referral by their GP, patients are randomized 1:1 into two study arms: Intervention and Control. The referring GP must specify which diagnostic evaluations he/she requests both in the intervention and in the control group.
Intervention arm: Patients in this arm shall be examined by an internal medicine specialist trained in FSD diagnostic evaluation at The Diagnostic Clinic for FSD. After parallel evaluation for FSD and other physical conditions, patients are given their diagnosis, along with patient education in what FSD is, as well as a letter to their GP regarding recommended management and treatment options.
Control arm: The comparison group in the randomized clinical trial will receive diagnostic as usual at the Diagnostic center or elsewhere in the secondary sector in The Central Denmark Region.
In this clinical trial, the investigators aim to evaluate the effectiveness in terms of health-related utility improvement for the patients as well as the healthcare and societal costs and cost-effectiveness of the clinic, compared to diagnostic as usual.
- Being tested
- Diagnostic evaluation at the Diagnostic Clinic for Functional Disorders, Diagnostic as usual
- Keywords
- Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome, Somatoform Disorders
- Medical subject headings
- Fibromyalgia, Irritable Bowel Syndrome, Fatigue Syndrome, Chronic, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic evaluation at the Diagnostic Clinic for Functional DisordersOther
The intervention consists of being examined at the Diagnostic Clinic for Functional Disorders. If an FSD diagnosis is established, the patient receives feed-back of on the FSD diagnosis and patient education about the condition. Subsequently, the clinic provides guidance to the GP regarding recommended management and treatment options tailored to each individual patient.
Diagnostic as usualOther
"Diagnostic as usual" consists in being referred to be examined at another existing specialist clinic in the secondary sector, as specified by the patient's GP.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Patients referred by their GP under suspicion of suffering from FSD are randomized to the intervention arm. Receives: Other: Diagnostic evaluation at the Diagnostic Clinic for Functional Disorders |
| Control arm | Active comparator | Patients referred by their GP under suspicion of suffering from FSD are randomized to "Diagnostic as usual" in the control arm. Receives: Other: Diagnostic as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare services utilization (i.e. direct costs)
Comparison of healthcare services utilization (of secondary and tertiary sector care) by the intervention group, compared to the control group. Data shall be drawn from Danish national and regional healthcare service registers.
Measured: 12 months prior to randomization and 12 months' follow-up
Cost-effectiveness analysis (CEA) (direct and indirect costs)
Cost-effectiveness analysis (CEA), comparing the intervention and the control group from both a healthcare (direct costs) and a societal perspective (indirect costs) combining data on incremental costs and incremental effects; adjusted for differences in mean utility score and mean costs at baseline (1 year prior to randomization).
Measured: 12 months prior to randomization and 12 months' follow-up
Secondary outcomes (4)
Public expenses associated with occupational status and social benefits (i.e. indirect costs)
Comparison of expenses associated with occupational status and social benefits of the intervention group, compared to the control group. Data shall be drawn from the Danish Register-based Evaluation of Marginalisation (DREAM) database.
Measured: 12 months prior to randomization and 12 months' follow-up
Effectiveness: Health-related quality of life (via the the Short Form 36 Total Score)
Difference between the intervention group and the control group in health-related quality of life, measured by the Total Score of the Short Form 36 (SF-36). The SF-36 is summarized in a score on a scale from 0-100 where 100 is the best possible health-related quality of life.
Measured: Baseline, 3- and 12-months' follow-up
Effectiveness: Perceived physical health
Difference between the intervention group and the control group in perceived physical health, measured by an aggregate score of the 'physical functioning', 'bodily pain' and 'vitality' subscales of the Short Form-36. This aggregate score has a minimum of 15 and a maximum of 65 and a higher score indicates better physical health. This outcome encompasses physical domains which have been previously found to be affected in functional somatic disorders.
Measured: Baseline, 3- and 12-months' follow-up
Effectiveness (via Patient-reported Clinical Global Improvement)
Patients evaluate their overall health as "much worse", " somewhat worse ", "about the same", "somewhat better" or "much better" compared to 1 year prior, at 3 and 12 months after randomization. Specifically, we shall compare the share of patients in the intervention group vs. the control group who evaluate their overall health as "somewhat better" or "much better".
Measured: At 3- and 12-months' follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Jul 2019
- Primary completion31 Dec 2025
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bodily Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospitalet Silkeborg
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Michael Moesmann Madsen, Regionshospitalet Silkeborg
- Investigators
- Michael M Madsen, MD MPH MSc, Principal investigator, Regionshospitalet SilkeborgLise K Gormsen, MD PhD, Study chair, Funktionelle Lidelser, Aarhus UniversitetshospitalChristian Trolle, MD PhD, Study director, Regionshospitalet SilkeborgPer Fink, MD Dr. Med PhD, Study director, Funktionelle Lidelser, Aarhus Universitetshospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025617
- Sponsor's protocol ID
- 147304
- Acronym
- DISTRESS
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madsen MM, Trolle C, Fynne LV, Colombo M, Pedersen RL, Sorensen VN, Christensen SR, Fink P, Gormsen LK. Early identification of functional somatic disorders in an internal medicine diagnostic clinic: The DISTRESS trial. Contemp Clin Trials. 2025 Nov;158:108082. doi: 10.1016/j.cct.2025.108082. Epub 2025 Sep 17.
PubMed 40972891Madsen MM, Trolle C, Fynne L, Ornbol E, Fink P, Gormsen LK. Can internal medicine specialists diagnose functional somatic disorders (FSDs)? Training and comparison with FSD specialists. PLoS One. 2024 Jul 12;19(7):e0307057. doi: 10.1371/journal.pone.0307057. eCollection 2024.
PubMed 38995907
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Evaluation of a New Diagnostic Clinic for Functional Disorders - the DISTRESS Trial
- ClinicalTrials.gov ID
- NCT06025617
- Acronym / sponsor ID
- DISTRESS / 147304
- Keywords
- Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome, Somatoform Disorders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Regionshospitalet SilkeborgUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 which no clinical or paraclinical tests at present have been found useable for establishing the diagnosis. The disorders range from mild and transient to severe, chronic and disabling, and are common in all medical settings, both in primary and secondary care. FSD is costly for society due to high health care use, and the reduction of patients' labor market participation. Arguably, insufficient diagnostic availability is part of the reason some patients develop more severe, chronic and disabling FSD. The Diagnostic Clinic for FSD was set up at Regionshospitalet to alleviate this diagnostic need in the secondary care setting.
The DISTRESS trial is a pragmatic randomized clinical trial. After referral by their GP, patients are randomized 1:1 into two study arms: Intervention and Control. The referring GP must specify which diagnostic evaluations he/she requests both in the intervention and in the control group.
Intervention arm: Patients in this arm shall be examined by an internal medicine specialist trained in FSD diagnostic evaluation at The Diagnostic Clinic for FSD. After parallel evaluation for FSD and other physical conditions, patients are given their diagnosis, along with patient education in what FSD is, as well as a letter to their GP regarding recommended management and treatment options.
Control arm: The comparison group in the randomized clinical trial will receive diagnostic as usual at the Diagnostic center or elsewhere in the secondary sector in The Central Denmark Region.
In this clinical trial, the investigators aim to evaluate the effectiveness in terms of health-related utility improvement for the patients as well as the healthcare and societal costs and cost-effectiveness of the clinic, compared to diagnostic as usual.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Diagnostic evaluation at the Diagnostic Clinic for Functional DisordersPatients referred by their GP under suspicion of suffering from FSD are randomized to the intervention arm. |
| Control arm | Active comparator | Other: Diagnostic as usualPatients referred by their GP under suspicion of suffering from FSD are randomized to "Diagnostic as usual" in the control arm. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic evaluation at the Diagnostic Clinic for Functional DisordersThe intervention consists of being examined at the Diagnostic Clinic for Functional Disorders. If an FSD diagnosis is established, the patient receives feed-back of on the FSD diagnosis and patient education about the condition. Subsequently, the clinic provides guidance to the GP regarding recommended management and treatment options tailored to each individual patient. | Other | Intervention arm |
| Diagnostic as usual"Diagnostic as usual" consists in being referred to be examined at another existing specialist clinic in the secondary sector, as specified by the patient's GP. | Other | Control arm |
Primary outcome
Healthcare services utilization (i.e. direct costs)
Time frame: 12 months prior to randomization and 12 months' follow-up
Comparison of healthcare services utilization (of secondary and tertiary sector care) by the intervention group, compared to the control group. Data shall be drawn from Danish national and regional healthcare service registers.
Cost-effectiveness analysis (CEA) (direct and indirect costs)
Time frame: 12 months prior to randomization and 12 months' follow-up
Cost-effectiveness analysis (CEA), comparing the intervention and the control group from both a healthcare (direct costs) and a societal perspective (indirect costs) combining data on incremental costs and incremental effects; adjusted for differences in mean utility score and mean costs at baseline (1 year prior to randomization).
4 secondary outcomes
Public expenses associated with occupational status and social benefits (i.e. indirect costs)
Time frame: 12 months prior to randomization and 12 months' follow-up
Effectiveness: Health-related quality of life (via the the Short Form 36 Total Score)
Time frame: Baseline, 3- and 12-months' follow-up
Effectiveness: Perceived physical health
Time frame: Baseline, 3- and 12-months' follow-up
Effectiveness (via Patient-reported Clinical Global Improvement)
Time frame: At 3- and 12-months' follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 40972891Madsen MM, Trolle C, Fynne LV, Colombo M, Pedersen RL, Sorensen VN, Christensen SR, Fink P, Gormsen LK. Early identification of functional somatic disorders in an internal medicine diagnostic clinic: The DISTRESS trial. Contemp Clin Trials. 2025 Nov;158:108082. doi: 10.1016/j.cct.2025.108082. Epub 2025 Sep 17.
- Derived from this study: PubMed 38995907Madsen MM, Trolle C, Fynne L, Ornbol E, Fink P, Gormsen LK. Can internal medicine specialists diagnose functional somatic disorders (FSDs)? Training and comparison with FSD specialists. PLoS One. 2024 Jul 12;19(7):e0307057. doi: 10.1371/journal.pone.0307057. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael M Madsen, MD MPH MSc principal investigator
Regionshospitalet Silkeborg
Lise K Gormsen, MD PhD study chair
Funktionelle Lidelser, Aarhus Universitetshospital
Christian Trolle, MD PhD study director
Regionshospitalet Silkeborg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic evaluation at the Diagnostic Clinic for Functional Disorders and Diagnostic as usual in people with Bodily Distress Syndrome and Functional Somatic Disorder, run by Regionshospitalet Silkeborg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare services utilization (i.e. direct costs) (time frame: 12 months prior to randomization and 12 months' follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06025617, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.