Trial document




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  DRKS00016160

Trial Description

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Title

Assessment of the functional state and Serum concentrations of pro- and anti-inflammatory mediators in individuals with grief and complicated grief.

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Trial Acronym

GRIF Study (Grief and Inflammation)

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URL of the Trial

http://

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Brief Summary in Lay Language

This study will determine changes in scores (grief inventory) and serum concentrations of inflammatory markers in individuals with complicated grief.

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Brief Summary in Scientific Language

The distinction between an acute stress reaction and complicated grief gained diagnostic and therapeutic recognition in the past years. So far, subjective score-based screening Tools were used to measure grief. Most recently, preclinical and clinical studies point to a pro-inflammatory state under such circumstances.
Hence, in a first step, this study approaches to quantify changes in concentrations of inflammatory mediators (serum/saliva) und to determine possible relationships between molecular changes and clinical phenotypes.

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Organizational Data

  •   DRKS00016160
  •   2018/12/14
  •   [---]*
  •   yes
  •   Approved
  •   315/18, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F43 -  Reaction to severe stress, and adjustment disorders
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   This study approaches to quantify changes in concentrations of inflammatory mediators (serum/saliva) using enzym-linked immuno-assayand to determine possible relationships between molecular changes and clinical phenotypes compared to an age-/gender matched healthy cohort. Clinical phenotyping will be assessed by score-based Evaluation (e.g. guideline-based structured interview).
  •   Age- and gender-matched healthy controls
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Screening
  •   Other
  •   IV
  •   N/A
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Primary Outcome

Concentration changes of pro- and anti-inflammatory marker in serum and saliva will be determined using enzym-linked immuno Assay (ELISA). Saliva and Serum samples will be collected between 08.00-10.00 am within the study period (2 time points).

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Secondary Outcome

Correlation with changes of the functional state of the grief participants.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/12/10
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

Age 18-75 years
Relative of patients of the palliativ care unit
Willigness to participate in the study

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Exclusion Criteria

Neurological disorders - substance abuse - psychiatric disorders - cardiovascular disorders - malignancy - pregnancy - acute/chronic infections - between 18-75 years

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Addresses

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    • Medizinische PsychologieNEMO
    • Mr.  Prof. Dr.med.  Rene  Hurlemann 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Rheinische Friedrich-Wilhelms-Universität BonnInstitute of Experimental Immunology
    • Ms.  Dr.  Zeinab  Abdullah 
    • Sigmund Freud Strasse 25
    • 53127  Bonn
    • Germany
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    • Medizinische PsychologieNEMO
    • Mr.  PD Dr.med.  Thomas M.  Kinfe 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Klinik für Palliativmedizin
    • Mr.  Prof Dr.med.  Lukas  Radbruch 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Psychiatrie, Abteilung Medizinische Psychologie
    • Mr.  Prof  Rene  Hurlemann 
    • Sigmund-Freud-Str.23
    • 53105  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Study Protocol
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* This entry means the parameter is not applicable or has not been set.