Randomized Controlled Trial of Stress Reduction and Lifestyle Modification for Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- Behavioral: lifestyle-modificationBehavioral: Control group
- Registration Number
- NCT02721823
- Lead Sponsor
- Universität Duisburg-Essen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 92
- 18 to 75 years
- diagnosis of ulcerative colitis
- Currently in remission, remission not longer than 12 months
- limited quality of life or increased subjective stress level
- Infectious or chronic active ulcerative colitis
- Taking glucocorticoids or immunosuppressants within the last 3 months, except stable medication using azathioprine
- colectomy
- serious psychological disorder (for example: major depression, addiction, schizophrenia)
- serious comorbid somatic disease (for example: diabetes mellitus, oncological disease)
- pregnancy
- participation in stress reduction program or clinical studies to psychological interventions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lifestyle-modification lifestyle-modification Once a week for 10 weeks with a circumference of 60 hours with mindfulness-based stress reduction and further process of the Mind / body medicine. control group Control group A unique education unit within the scope of 3 hours on the influence of lifestyle factors on the disease and self-help materials for the independent training.
- Primary Outcome Measures
Name Time Method Disease-specific quality of life 12 weeks Inflammatory Bowel Disease Questionnaire (IBD-Q)
- Secondary Outcome Measures
Name Time Method faecal calprotectin 108 weeks Histology 108 weeks Riley Score
Generic quality of life 108 weeks SF-36 health survey
Hemogram 108 weeks leukocyte, hemoglobin, hematocrit, platelet
faecal lactoferrin 108 weeks Disease-specific quality of life 108 weeks Inflammatory Bowel Disease Questionnaire (IBD-Q)
Perceived stress 108 weeks Perceived Stress Scale (PSS)
Blood sedimentation rate 108 weeks faecal PMN-elastase 108 weeks faecal polymorphonuclear elastase
Adverse events 108 weeks Disease activity 108 weeks Clinical Activity Index(CAI)
Endoscopic index 108 weeks Endoscopic-Index (sigmoidoscopy)
faecal polymorphonuclear (PMN)-elastase 12 weeks faecal polymorphonuclear elastase
faecal hBD-2 108 weeks human beta-defensin-2
Intestinal permeability 108 weeks LactoseMonitol
Anxiety and depression 108 weeks Hospital Anxiety and Depression Scale (HADS)
Irritable Bowel Syndrome Symptoms 108 weeks IBS Severity Scoring System (IBS-SSS)
faecal human beta-defensin-2 (hBD-2) 12 weeks Intestinal microbiota 108 weeks High-throughput 16S rRNA gene sequencing
C-reactive protein 108 weeks
Trial Locations
- Locations (1)
Kliniken Essen-Mitte, Knappschafts Krankenhaus
🇩🇪Essen, NRW, Germany