Randomized Controlled Trial of Stress Reduction and Lifestyle Modification for Ulcerative Colitis (MBMCol)

Randomized Controlled Trial on the Effect of Stress Reduction and Lifestyle Modification on Disease Activity in Ulcerative Colitis

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.

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.

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.

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.

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

Schlee C, Uecker C, Bauer N, Koch AK, Langhorst J. Multimodal stress reduction and lifestyle modification program for patients with ulcerative colitis: a qualitative study. BMC Complement Med Ther. 2022 Mar 8;22(1):60. doi: 10.1186/s12906-021-03478-w.