xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06025617</url>
    </required_header>
    <id_info>
      <org_study_id>147304</org_study_id>
      <nct_id>NCT06025617</nct_id>
    </id_info>
    <brief_title>DISTRESS Trial Functional Disorders - the DISTRESS Trial</brief_title>
    <acronym>DISTRESS</acronym>
    <official_title>Comprehensive Evaluation of a New Diagnostic Clinic for Functional Disorders - the DISTRESS Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Regionshospitalet Silkeborg</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Aarhus University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Regionshospitalet Silkeborg</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A Diagnostic Clinic for Functional Somatic Disorders (FSD) has been set up at the outpatient&#xD;
        diagnostic center at Regionshospitalet Silkeborg. The objective of the clinic is to support&#xD;
        General Practitioners (GPs) by offering early stage diagnostic evaluation of whether a&#xD;
        patient has an FSD or the symptoms were caused by another physical illness or mental&#xD;
        disorder.&#xD;
  &#xD;
        As a novelty in this project, Internal Medicine consultants examine the patients for FSD,&#xD;
        after having received training in diagnosing FSD by FSD experts. By performing diagnostic&#xD;
        evaluation for physical diseases and FSD simultaneously, the investigators believe that the&#xD;
        new clinic shall be able to accelerate the establishment of a final diagnosis for these&#xD;
        patients who would otherwise likely undergo a protracted diagnostic course involving&#xD;
        sequential evaluations at various specialty clinics.&#xD;
  &#xD;
        The DISTRESS trial is a pragmatic randomized clinical trial which aims to evaluate the&#xD;
        Diagnostic Clinic for FSD in terms of clinical cost-effectiveness outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Functional Somatic Disorders (FSD) are conditions where patients present with characteristic&#xD;
        patterns of physical symptoms, accompanied by impairment or disability. FSD is a clinical&#xD;
        diagnosis for which no clinical or paraclinical tests at present have been found useable for&#xD;
        establishing the diagnosis. The disorders range from mild and transient to severe, chronic&#xD;
        and disabling, and are common in all medical settings, both in primary and secondary care.&#xD;
        FSD is costly for society due to high health care use, and the reduction of patients' labor&#xD;
        market participation. Arguably, insufficient diagnostic availability is part of the reason&#xD;
        some patients develop more severe, chronic and disabling FSD. The Diagnostic Clinic for FSD&#xD;
        was set up at Regionshospitalet to alleviate this diagnostic need in the secondary care&#xD;
        setting.&#xD;
  &#xD;
        The DISTRESS trial is a pragmatic randomized clinical trial. After referral by their GP,&#xD;
        patients are randomized 1:1 into two study arms: Intervention and Control. The referring GP&#xD;
        must specify which diagnostic evaluations he/she requests both in the intervention and in the&#xD;
        control group.&#xD;
  &#xD;
        Intervention arm: Patients in this arm shall be examined by an internal medicine specialist&#xD;
        trained in FSD diagnostic evaluation at The Diagnostic Clinic for FSD. After parallel&#xD;
        evaluation for FSD and other physical conditions, patients are given their diagnosis, along&#xD;
        with patient education in what FSD is, as well as a letter to their GP regarding recommended&#xD;
        management and treatment options.&#xD;
  &#xD;
        Control arm: The comparison group in the randomized clinical trial will receive diagnostic as&#xD;
        usual at the Diagnostic center or elsewhere in the secondary sector in The Central Denmark&#xD;
        Region.&#xD;
  &#xD;
        In this clinical trial, the investigators aim to evaluate the effectiveness in terms of&#xD;
        health-related utility improvement for the patients as well as the healthcare and societal&#xD;
        costs and cost-effectiveness of the clinic, compared to diagnostic as usual.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2019</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>Outcome data is blinded to the investigator during data analysis as to intervention vs. comparison arm assignment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Healthcare services utilization (i.e. direct costs)</measure>
      <time_frame>12 months prior to randomization and 12 months' follow-up</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cost-effectiveness analysis (CEA) (direct and indirect costs)</measure>
      <time_frame>12 months prior to randomization and 12 months' follow-up</time_frame>
      <description>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).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Public expenses associated with occupational status and social benefits (i.e. indirect costs)</measure>
      <time_frame>12 months prior to randomization and 12 months' follow-up</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effectiveness: Health-related quality of life (via the the Short Form 36 Total Score)</measure>
      <time_frame>Baseline, 3- and 12-months' follow-up</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effectiveness: Perceived physical health</measure>
      <time_frame>Baseline, 3- and 12-months' follow-up</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effectiveness (via Patient-reported Clinical Global Improvement)</measure>
      <time_frame>At 3- and 12-months' follow-up</time_frame>
      <description>Patients evaluate their overall health as &quot;much worse&quot;, &quot; somewhat worse &quot;, &quot;about the same&quot;, &quot;somewhat better&quot; or &quot;much better&quot; 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 &quot;somewhat better&quot; or &quot;much better&quot;.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Symptom level comparison</measure>
      <time_frame>At 3- and 12 months follow-up</time_frame>
      <description>Comparison of the intervention group and the control group regarding the number and severity of symptoms via the Bodily Distress Syndrome 25 (BDS-25) symptom checklist. This checklist asks 'have you been bothered by', followed by a list of 25 symptoms comprising the four symptom clusters of Bodily Distress Syndrome (BDS). The checklist measures symptoms on a 5-point rating scale from 0 ('not at all bothersome') to 4 ('a lot bothersome'). The sum score is calculated by adding the single item scores from the 25 items (ranging from 0 to 100, where a higher score implies greater bother from symptoms).</description>
    </other_outcome>
    <other_outcome>
      <measure>Health anxiety</measure>
      <time_frame>At 3- and 12 months follow-up</time_frame>
      <description>Comparison of the intervention group and the control group regarding health anxiety using Whiteley-6-R index. The Whiteley indices measure health anxiety. The Whiteley-6-R, which excludes two items on somatic symptoms while adding one item on obsessive rumination has been found to have better psychometric properties. The Whiteley-6-R has a total score range of 0-24, where a higher score indicates a higher level of health anxiety.</description>
    </other_outcome>
    <other_outcome>
      <measure>Overall physical health</measure>
      <time_frame>At 3- and 12 months follow-up</time_frame>
      <description>Overall health is assessed with a single item from the 36-item Short-Form Health Survey (SF-36), estimating self-perceived health on a 5-point rating scale from 'excellent' to 'poor'. Higher score on this item indicates poorer health.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">352</enrollment>
    <condition>Bodily Distress Syndrome</condition>
    <condition>Functional Somatic Disorder</condition>
    <arm_group>
      <arm_group_label>Intervention arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients referred by their GP under suspicion of suffering from FSD are randomized to the intervention arm.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients referred by their GP under suspicion of suffering from FSD are randomized to &quot;Diagnostic as usual&quot; in the control arm.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Diagnostic evaluation at the Diagnostic Clinic for Functional Disorders</intervention_name>
      <description>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.</description>
      <arm_group_label>Intervention arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Diagnostic as usual</intervention_name>
      <description>&quot;Diagnostic as usual&quot; consists in being referred to be examined at another existing specialist clinic in the secondary sector, as specified by the patient's GP.</description>
      <arm_group_label>Control arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Study population:&#xD;
  &#xD;
          Participants were drawn from the population of the Central Denmark Region. To be considered&#xD;
          for inclusion, patients had to be referred by their GP.&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being referred to the clinic by their GP due to symptoms consistent with a possible&#xD;
               diagnosis of moderate or severe FSD.&#xD;
  &#xD;
            -  Symptoms having been present for at least 6 months and no more than 3 years.&#xD;
  &#xD;
            -  Having undergone at least 2 diagnostic evaluations (e.g. imaging studies or specialist&#xD;
               evaluations) at physical specialty clinics or hospitals in the past year.&#xD;
  &#xD;
            -  Age 18-60.&#xD;
  &#xD;
            -  Being of ethnic western cultural upbringing.&#xD;
  &#xD;
            -  Understands and speaks Danish fluently.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having another severe chronic disease which explains the reduced level of functioning.&#xD;
  &#xD;
            -  Having been previously referred to or evaluated for FSD at this or another clinic&#xD;
               specializing in functional disorders.&#xD;
  &#xD;
            -  Previous diagnosis of FSD.&#xD;
  &#xD;
            -  Alcohol or other substance-dependency or -abuse.&#xD;
  &#xD;
            -  Emergent psychiatric illness or emergent elevated risk of harm to self or others&#xD;
               requiring psychiatric evaluation for possible need of acute or sub-acute psychiatric&#xD;
               hospitalization.&#xD;
  &#xD;
            -  Current or prior diagnosis of psychosis (ICD10 F2x diagnosis), bipolar affective&#xD;
               disorder (ICD10 F31.x diagnosis) or depression with psychotic symptoms (ICD10 F32.3 or&#xD;
               F33.3 diagnosis).&#xD;
  &#xD;
            -  Currently pregnant.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael M Madsen, MD MPH MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Regionshospitalet Silkeborg</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Lise K Gormsen, MD PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Funktionelle Lidelser, Aarhus Universitetshospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Christian Trolle, MD PhD</last_name>
      <role>Study Director</role>
      <affiliation>Regionshospitalet Silkeborg</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Per Fink, MD Dr. Med PhD</last_name>
      <role>Study Director</role>
      <affiliation>Funktionelle Lidelser, Aarhus Universitetshospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michael M Madsen, MD MPH MSc</last_name>
      <phone>+4578415000</phone>
      <email>michms@rm.dk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Regionshospitalet Silkeborg</name>
        <address>
          <city>Silkeborg</city>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anne Sofie B Glenting, Cand.cur</last_name>
        <phone>+78417865</phone>
        <email>ANNJE9@rm.dk</email>
      </contact>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Regionshospitalet Silkeborg</investigator_affiliation>
      <investigator_full_name>Michael Moesmann Madsen</investigator_full_name>
      <investigator_title>Clinical assistant and Medical Doctor</investigator_title>
    </responsible_party>
    <keyword>Fibromyalgia</keyword>
    <keyword>Irritable Bowel Syndrome</keyword>
    <keyword>Chronic Fatigue Syndrome</keyword>
    <keyword>Somatoform Disorders</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06025617
  org study id: 147304
  nct id: NCT06025617
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Single (Investigator)
  masking description: Outcome data is blinded to the investigator during data analysis as to intervention vs. comparison arm assignment.
  measure: Healthcare services utilization (i.e. direct costs)
  time frame: 12 months prior to randomization and 12 months' follow-up
  description: 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.
  measure: Cost-effectiveness analysis (CEA) (direct and indirect costs)
  time frame: 12 months prior to randomization and 12 months' follow-up
  description: 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).
  measure: 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
  description: 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.
  measure: Effectiveness: Health-related quality of life (via the the Short Form 36 Total Score)
  time frame: Baseline, 3- and 12-months' follow-up
  description: 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.
  measure: Effectiveness: Perceived physical health
  time frame: Baseline, 3- and 12-months' follow-up
  description: 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.
  measure: Effectiveness (via Patient-reported Clinical Global Improvement)
  time frame: At 3- and 12-months' follow-up
  description: 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".
  measure: Symptom level comparison
  time frame: At 3- and 12 months follow-up
  description: Comparison of the intervention group and the control group regarding the number and severity of symptoms via the Bodily Distress Syndrome 25 (BDS-25) symptom checklist. This checklist asks 'have you been bothered by', followed by a list of 25 symptoms comprising the four symptom clusters of Bodily Distress Syndrome (BDS). The checklist measures symptoms on a 5-point rating scale from 0 ('not at all bothersome') to 4 ('a lot bothersome'). The sum score is calculated by adding the single item scores from the 25 items (ranging from 0 to 100, where a higher score implies greater bother from symptoms).
  measure: Health anxiety
  time frame: At 3- and 12 months follow-up
  description: Comparison of the intervention group and the control group regarding health anxiety using Whiteley-6-R index. The Whiteley indices measure health anxiety. The Whiteley-6-R, which excludes two items on somatic symptoms while adding one item on obsessive rumination has been found to have better psychometric properties. The Whiteley-6-R has a total score range of 0-24, where a higher score indicates a higher level of health anxiety.
  measure: Overall physical health
  time frame: At 3- and 12 months follow-up
  description: Overall health is assessed with a single item from the 36-item Short-Form Health Survey (SF-36), estimating self-perceived health on a 5-point rating scale from 'excellent' to 'poor'. Higher score on this item indicates poorer health.
  arm group label: Intervention arm
  arm group type: Experimental
  description: Patients referred by their GP under suspicion of suffering from FSD are randomized to the intervention arm.
  arm group label: Control arm
  arm group type: Active Comparator
  description: Patients referred by their GP under suspicion of suffering from FSD are randomized to "Diagnostic as usual" in the control arm.
  intervention type: Other
  intervention name: Diagnostic evaluation at the Diagnostic Clinic for Functional Disorders
  description: 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.
  arm group label: Intervention arm
  intervention type: Other
  intervention name: Diagnostic as usual
  description: "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.
  arm group label: Control arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Michael M Madsen, MD MPH MSc
  role: Principal Investigator
  affiliation: Regionshospitalet Silkeborg
  last name: Lise K Gormsen, MD PhD
  role: Study Chair
  affiliation: Funktionelle Lidelser, Aarhus Universitetshospital
  last name: Christian Trolle, MD PhD
  role: Study Director
  affiliation: Regionshospitalet Silkeborg
  last name: Per Fink, MD Dr. Med PhD
  role: Study Director
  affiliation: Funktionelle Lidelser, Aarhus Universitetshospital
  last name: Michael M Madsen, MD MPH MSc
  phone: +4578415000
  email: michms@rm.dk
  facility: 
  status: Recruiting
  contact: 
  country: Denmark
  responsible party type: Principal Investigator
  investigator affiliation: Regionshospitalet Silkeborg
  investigator full name: Michael Moesmann Madsen
  investigator title: Clinical assistant and Medical Doctor
  mesh term: Syndrome
  sharing ipd: No