Deep-phenotyping and personalized therapy of patients with irritable bowel syndrome
Not Applicable
Recruiting
- Conditions
- F45.32K58Irritable bowel syndrome
- Registration Number
- DRKS00032767
- Lead Sponsor
- niversitätsklinikum Heidelberg, Abteilung für Allgemeine Innere Medizin und Psychosomatik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
* Irritable bowel syndrome according to ROM-IV criteria,
* Irritable bowel syndrome in clinical assessment,
* Patients who agree to participate in the study for at least 5 months,
* Written informed consent
Exclusion Criteria
* Severe psychopathology preventing group therapy (e.g. acute schizophrenic disorder, acute suicidality, current substance dependence (alcohol/drugs)).
* Psychopathology preventing short-term EMDR treatment (e.g. severe dissociative symptoms (DES-II >25%), complex post-traumatic stress disorder).
* Severe comorbid organic disorder preventing participation (e.g. palliative terminal cancer, serious nephrological, hepatic, cardiovascular or neurological disease).
*Pregnancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility of the study at the end of treatment<br><br>The feasibility criterion is considered to be met if a sufficient number of patients agree to participate in the study and if 70% of the original participants remain part of the study until its conclusion.
- Secondary Outcome Measures
Name Time Method An insight in the effectiveness of optimized personalized therapy will be gained according to the following:<br><br>•Simultaneous and time-depended relationships between somatic and psychological parameters during the study and at follow-up, measured according to entries in online diaries. <br><br>•Reduction of symptom severity and illness anxiety measured by IBS-SSS (irritable bowel syndrome severity scoring system) and WI-7 (whiteley index 7) in pre-post comparison and at follow-up.<br><br>•Improvement in quality of life, measured according to the FDD-Qol (Functional Digestive Disorders Quality of Life) in pre-post comparison and at follow-up.<br><br>•Reduction in anxiety and depression-related symptoms, measured according to the PHQ-9 (Patient Health Questionnaire 9) and the GAD-7 (Generalized Anxiety Disorder 7) in pre-post comparison and at follow-up.<br><br>•Change in somatic parameters (microbiome, heart rate variability, pain threshold) in pre-post comparison and at follow-up.