Trial document




drksid header

  DRKS00011685

Trial Description

start of 1:1-Block title

Title

Characterization of patients with high somatic symptom severity

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Somatic complaints without organic explanation cause high functional impairment and low quality of life. Many patients suffer from abdominal pain and digestion problems, joint- and musclepain, palpitations and dizziness or low energy and fatigue. We want to explore the associations between unclear somatic complaints, psychosocial and biographic burden. Therefore, we conduct a crosssectional survey study. We want to compare patients with unclear somatic complaints (e.g. irritable bowel syndrom) with somatic complaints (e.g. inflammatory bowel diseases), mental burden (anxiety/ depression) and healthy controls.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Functional/ somatoform complaints cause high somatic symptom severity and are often unclear.
Somatic complaints affect many patients, cause high functional impairment and low quality of life. Therefore, there is a need for a deeper understanding of functional/ somatoform complaints to develop more effective mechanism-based treatment options. To improve the understanding, we want to explore the associations between somatic and mental symptom patterns and psychodynamic characteristics (structure, mentalization, attachment, aversive childhood events).

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011685
  •   2017/02/02
  •   [---]*
  •   yes
  •   Approved
  •   S-635/2016, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F45 -  Somatoform disorders
  •   K50 -  Crohn disease [regional enteritis]
  •   K51 -  Ulcerative colitis
  •   F41 -  Other anxiety disorders
  •   F32 -  Depressive episode
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Crosssectional observational study: Set of questionnaires (somatic complaints, mental burden and psychodynamic characteristics: aversive childhood experiences, structure, attachment, mentalization)
    patients with somatoform/functional complaints (Somatic Symptom Scale-8 ≥8) or specific functional gastrointestinal complaints (ROME III positive)
  •   Crosssectional observational study: Set of questionnaires (somatic complaints, mental burden and psychodynamic characteristics: aversive childhood experiences, structure, attachment, mentalization)
    patients with somatic complaints (inflammatory bowel diseases)
  •   Crosssectional observational study: Set of questionnaires (somatic complaints, mental burden and psychodynamic characteristics: aversive childhood experiences, structure, attachment, mentalization)
    patients with anxiety/depressive symptoms (Generalized Anxiety Disorder [GAD]-7 ≥ 10 OR Patient Health Questionnaire[PHQ]-9 ≥ 10)
  •   Crosssectional observational study: Set of questionnaires (somatic complaints, mental burden and psychodynamic characteristics: aversive childhood experiences, structure, attachment, mentalization)
    Online Survey: healthy participants
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

crossectional observational study (descriptive and explorative): no primary outcome;
characterization and group comparisions according to symptom severity (physical: SSS-8, IBS-SSS; mental: GAD-7, PHQ-9, WI-7, PHQ panic module; general: VAS des EQ-5D), diagnostics (DSM-V: Somatic Symptom Disorder (SSD-12), ICD-10: somatoform disorder, functional disorder [ROME criteria]) and psychodynamic characteristics
(aversive childhood experiences: ACE-criteria, structure: OPD-SF, Metalizing: Mentalizing Questionnaire [MZQ], attachment: ECR-RD und RQ).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

[---]*

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/02/01
  •   1300
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Inclusion criteria for patients: high somatic symptom severity (SSS-8 ≥ 8) OR Somatic Symptom Disorder (SSD-12) OR GAD-7 ≥10 OR PHQ-9 ≥10 OR IBD positiv
Inclusion criteria for healthy participants: low somatic symptom severity (SSS-8 <8), no Somatic Symptom Disorder (SSD-12), GAD-7 <10, PHQ-9 <10, IBD negativ, Charlson Comorbidity Index (CCI) = 0, no psychic or functional disorder according to patient self-report

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Lacking language skills, psychosis, severe cognitive impairment, severe acute organic disease

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Heidelberg, Klinik für Allgemeine Innere Medizin und Psychosomatik
    • Mr.  Dr. med.  Jonas  Tesarz 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Heidelberg, Klinik für Allgemeine Innere Medizin und Psychosomatik
    • Mr.  Dr. med.  Jonas  Tesarz 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Heidelberg, Klinik für Allgemeine Innere Medizin und Psychosomatik
    • Ms.  M.Sc.-Psych.  Sabrina  Berens 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Köhler-Stiftung
    • Barkhovenallee 1
    • 45239  Essen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.