NCT02721823

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Universität Duisburg-Essen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
BEHAVIORAL	lifestyle-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.
BEHAVIORAL	Control 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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2016-03-29
• Last updated: 2017-05-10

Locations

1 site across 1 country: Germany