Effect of a Stress Reduction and Lifestyle Modification Programme on the Quality of Life of Crohn's Disease Patients (MBMCrohn)

Jost Langhorst

Status: Completed

Conditions: Crohn Disease

Treatments: Behavioral: lifestyle-modification; Behavioral: waiting control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05182645

19096

Details and patient eligibility

About

Patients with crohn's disease 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 in patients with uncreative colitis. The study will examine the promotion of the quality of life of patients with crohn's disease and the positive Influence on stress, psychological symptoms and physiological parameters.

Full description

40 patients with ulcerative colitis will be randomized in an Intervention group and a control group for 10 weeks. The primary outcome is the feasibility of the study, the intervention and the examinations. The Secondary outcomes are disease-specific quality of life, disease-activity, stress, psychological symptoms, inflammatory parameters, disease activity parameters, bowel parameter and the microbiome. As qualitative parameters, the influence of the disease on everyday life and the experience/ impact/ implementability of the programme will be investigated. Lastly, undesirable events will be recorded.

Enrollment: 42 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 18 and 75 years
• Presence of a confirmed diagnosis of Crohn's disease
• In remission (not longer than 12 months, or mild to moderate clinical activity (HBI < 16)
• Medication that has been stable for at least 3 months, regardless of whether glucocorticoids, immunosuppressive drugs, azathioprine, or other drug treatments according to MBMCrohn - Version 1.0 from 06.12.2019 Page 7 Guideline
• Signed declaration of consent

Exclusion criteria

• infectious or refractory Crohn's disease with severe course
• Complete colectomy
• Severe psychological illness (e.g. depression requiring treatment, addiction, schizophrenia)
• Severe comorbid somatic disease (e.g. diabetes mellitus, oncological disease)
• Pregnancy
• Participation in stress reduction programmes or clinical studies on psychological interventions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 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

waiting 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. After the follow-up measurement opportunity to participate in the program.

Treatment:

Behavioral: waiting control group