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

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.

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