Effects of positive treatment expectation on sickness symptoms in a human model of acute systemic inflammatio
Not Applicable
- Conditions
- healthy male and female volunteers
- Registration Number
- DRKS00023088
- Lead Sponsor
- niversitätsklinikum Essen, Institut für Medizinische Psychologie und Verhaltensimmunbiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 124
Inclusion Criteria
healthy male and female volunteers aged 18-50
Exclusion Criteria
acute/ chronic physical diseases (e.g. gastrointestinal disorders, liver/ kidney diseases, cardiovascular diseases, diabetes mellitus, obesity); pathological laboratory values (e.g. CRP); regular use of medications (except for oral contraception); contraindications for ibuprofen intake; evidence of mental disorders according to DSM-V criteria based on validated screening tools (especially depression, anxiety disorders); MRI-specific exclision criteria (phobic anxiety, claustrophobia, ferromagnetic implants, etc.); women: pregnancy or lactation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method sickness symptoms (bodily and psychological sickness symptoms), assessed with standardized questionnaires (STADI, STAI, GASE, MDBF, KSS); pressure pain thresholds (PPT), assesed with a digital Algometer; emotion processing, assessed with a spatial cueing paradigm (Emotional Posner Task). All Parameter will be repeatedly assessed before (baseline), as well as 1,2,3,4,6 and 24 hours (questionnaires) or 2 (Emotional Eosner Task) or 3 (PPT) hours after LPS injection respectively.
- Secondary Outcome Measures
Name Time Method repeated measurement of the following parameters (baseline as well as 1,2,3,4,6, and 24 hours after LPS injection): Plasma/ Serum/ Saliva concentrations of pro-/ anti-inflammatory cytokines and neuroendocrine parameters, B- and T-cell-function (cytokine secretion, proliferation), blood pressure, heart rate, body temperature.<br><br>measurement of the following moderator and predictor variables during visits before the experimental day: psychological trait characteristics, coping, attitude towards drugs, treatment expectation, using standardized questionnaires; functional and structural imaging data (diffusion tension imaging, DTI; resting state activity).<br><br>in addition: salivary cortisol awakening response and alpha-amylase activity on two consecutive days before the experimental day.