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

Universität Duisburg-Essen

Status: Unknown

Conditions: Ulcerative Colitis

Treatments: Behavioral: lifestyle-modification; Behavioral: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT02721823

15-6554-BO

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

lifestyle-modification

Experimental group

Description:

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.

Treatment:

Behavioral: lifestyle-modification

control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control group