Ulcerative Colitis
Conditions
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.
Interventions
BEHAVIORALlifestyle-modification
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.
BEHAVIORALControl group
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.
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-specific quality of life | 12 weeks | Inflammatory Bowel Disease Questionnaire (IBD-Q) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity | 12 weeks | Mayo Disease Activity Index (Mayo Score) |
| Endoscopic index | 12 weeks | Endoscopic-Index (sigmoidoscopy) |
| Histology | 12 weeks | Riley Score |
| Generic quality of life | 12 weeks | Short Form (SF) -36 (items) health survey |
| Anxiety and depression | 12 weeks | Hospital Anxiety and Depression Scale (HADS) |
| Perceived stress | 12 weeks | Perceived Stress Scale (PSS) |
| Irritable Bowel Syndrome Symptoms | 12 weeks | IBS Severity Scoring System (IBS-SSS) |
| Hemogram | 12 weeks | leukocyte, hemoglobin, hematocrit, platelet |
| Blood sedimentation rate | 12 weeks | — |
| Disease-specific quality of life | 48 weeks | Inflammatory Bowel Disease Questionnaire (IBD-Q) |
| faecal calprotectin | 12 weeks | — |
| faecal lactoferrin | 12 weeks | — |
| faecal polymorphonuclear (PMN)-elastase | 12 weeks | faecal polymorphonuclear elastase |
| faecal PMN-elastase | 48 weeks | faecal polymorphonuclear elastase |
| faecal human beta-defensin-2 (hBD-2) | 12 weeks | — |
| faecal hBD-2 | 48 weeks | human beta-defensin-2 |
| Intestinal microbiota | 12 weeks | High-throughput 16S ribosomal ribonucleic acid (rRNA) gene sequencing |
| Intestinal permeability | 12 weeks | LactoseMonitol |
| Adverse events | 12 weeks | — |
| C-reactive protein | 12 weeks | — |
Countries
Germany
Contacts
Primary ContactJost Langhorst, Prof. Dr. med.
Outcome results
None listed