Patients with ulcerative colitis often suffer significant limitations to their quality of life, which are also conditioned by particular stress and psychosocial accompanying symptoms of the disease. A multimodal program for stress-reduction and lifestyle-modification has been shown to be effective in promoting the quality of life. The study will examine the promotion of the quality of life of patients with ulcerative colitis and the positive Influence on stress, psychological symptoms and physiological parameters. 92 patients with ulcerative colitis will be randomized in an Intervention group and a control group for 10 weeks. The primary outcome is the disease-specific quality of life, the secondary outcomes are stress, psychological symptoms, inflammatory parameters, disease activity parameters, bowel parameter and the microbiome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
92
The group intervention is carried out once a week for 10 weeks for a total of 60 hours with elements of mindfulness-based stress reduction (MBSR) and further process of the mind / body medicine. In this project, this program will be adapted to the specific needs of colitis patients.
Participants in this group receive a one-time education unit within the scope of 3 hours on the influence of lifestyle factors on the disease, also self-help materials for independent training offered. Following the follow-up measure also this group is given the opportunity to participate in the multimodal stress reduction- and lifestyle modification program.
Kliniken Essen-Mitte, Knappschafts Krankenhaus
Essen, North Rhine-Westphalia, Germany
RECRUITINGDisease-specific quality of life
Inflammatory Bowel Disease Questionnaire (IBD-Q)
Time frame: 12 weeks
Disease-specific quality of life
Inflammatory Bowel Disease Questionnaire (IBD-Q)
Time frame: 48 weeks
Disease-specific quality of life
Inflammatory Bowel Disease Questionnaire (IBD-Q)
Time frame: 60 weeks
Disease-specific quality of life
Inflammatory Bowel Disease Questionnaire (IBD-Q)
Time frame: 108 weeks
Disease activity
Mayo Disease Activity Index (Mayo Score)
Time frame: 12 weeks
Disease activity
Clinical Activity Index (CAI)
Time frame: 12 weeks
Disease activity
Mayo Disease Activity Index (Mayo Score)
Time frame: 48 weeks
Disease activity
Clinical Activity Index (CAI)
Time frame: 48 weeks
Disease activity
Mayo Disease Activity Index (Mayo Score)
Time frame: 60 weeks
Disease activity
Clinical Activity Index (CAI)
Time frame: 60 weeks
Disease activity
Mayo Disease Activity Index (Mayo Score)
Time frame: 108 weeks
Disease activity
Clinical Activity Index(CAI)
Time frame: 108 weeks
Endoscopic index
Endoscopic-Index (sigmoidoscopy)
Time frame: 12 weeks
Endoscopic index
Endoscopic-Index (sigmoidoscopy)
Time frame: 48 weeks
Endoscopic index
Endoscopic-Index (sigmoidoscopy))
Time frame: 60 weeks
Endoscopic index
Endoscopic-Index (sigmoidoscopy)
Time frame: 108 weeks
Histology
Riley Score
Time frame: 12 weeks
Histology
Riley Score
Time frame: 48 weeks
Histology
Riley Score
Time frame: 60 weeks
Histology
Riley Score
Time frame: 108 weeks
Generic quality of life
Short Form (SF) -36 (items) health survey
Time frame: 12 weeks
Generic quality of life
SF-36 health survey
Time frame: 48 weeks
Generic quality of life
SF-36 health survey
Time frame: 60 weeks
Generic quality of life
SF-36 health survey
Time frame: 108 weeks
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS)
Time frame: 48 weeks
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS)
Time frame: 60 weeks
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS)
Time frame: 108 weeks
Perceived stress
Perceived Stress Scale (PSS)
Time frame: 12 weeks
Perceived stress
Perceived Stress Scale (PSS)
Time frame: 48 weeks
Perceived stress
Perceived Stress Scale (PSS)
Time frame: 60 weeks
Perceived stress
Perceived Stress Scale (PSS)
Time frame: 108 weeks
Irritable Bowel Syndrome Symptoms
IBS Severity Scoring System (IBS-SSS)
Time frame: 12 weeks
Irritable Bowel Syndrome Symptoms
IBS Severity Scoring System (IBS-SSS)
Time frame: 48 weeks
Irritable Bowel Syndrome Symptoms
IBS Severity Scoring System (IBS-SSS)
Time frame: 60 weeks
Irritable Bowel Syndrome Symptoms
IBS Severity Scoring System (IBS-SSS)
Time frame: 108 weeks
Hemogram
leukocyte, hemoglobin, hematocrit, platelet
Time frame: 12 weeks
Hemogram
leukocyte, hemoglobin, hematocrit, platelet
Time frame: 48 weeks
Hemogram
leukocyte, hemoglobin, hematocrit, platelet
Time frame: 60 weeks
Hemogram
leukocyte, hemoglobin, hematocrit, platelet
Time frame: 108 weeks
Blood sedimentation rate
Time frame: 12 weeks
Blood sedimentation rate
Time frame: 48 weeks
Blood sedimentation rate
Time frame: 60 weeks
Blood sedimentation rate
Time frame: 108 weeks
C-reactive protein
Time frame: 12 weeks
C-reactive protein
Time frame: 48 weeks
C-reactive protein
Time frame: 60 weeks
C-reactive protein
Time frame: 108 weeks
faecal calprotectin
Time frame: 12 weeks
faecal calprotectin
Time frame: 48 weeks
faecal calprotectin
Time frame: 60 weeks
faecal calprotectin
Time frame: 108 weeks
faecal lactoferrin
Time frame: 12 weeks
faecal lactoferrin
Time frame: 48 weeks
faecal lactoferrin
Time frame: 60 weeks
faecal lactoferrin
Time frame: 108 weeks
faecal polymorphonuclear (PMN)-elastase
faecal polymorphonuclear elastase
Time frame: 12 weeks
faecal PMN-elastase
faecal polymorphonuclear elastase
Time frame: 48 weeks
faecal PMN-elastase
faecal polymorphonuclear elastase
Time frame: 60 weeks
faecal PMN-elastase
faecal polymorphonuclear elastase
Time frame: 108 weeks
faecal human beta-defensin-2 (hBD-2)
Time frame: 12 weeks
faecal hBD-2
human beta-defensin-2
Time frame: 48 weeks
faecal hBD-2
human beta-defensin-2
Time frame: 60 weeks
faecal hBD-2
human beta-defensin-2
Time frame: 108 weeks
Intestinal microbiota
High-throughput 16S ribosomal ribonucleic acid (rRNA) gene sequencing
Time frame: 12 weeks
Intestinal microbiota
High-throughput 16S rRNA gene sequencing
Time frame: 48 weeks
Intestinal microbiota
High-throughput 16S rRNA gene sequencing
Time frame: 60 weeks
Intestinal microbiota
High-throughput 16S rRNA gene sequencing
Time frame: 108 weeks
Intestinal permeability
LactoseMonitol
Time frame: 12 weeks
Intestinal permeability
LactoseMonitol
Time frame: 48 weeks
Intestinal permeability
LactoseMonitol
Time frame: 60 weeks
Intestinal permeability
LactoseMonitol
Time frame: 108 weeks
Adverse events
Time frame: 12 weeks
Adverse events
Time frame: 48 weeks
Adverse events
Time frame: 60 weeks
Adverse events
Time frame: 108 weeks
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