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

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05182645

19096

Ages 18-75
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 <

Medication that has been stable for at least 3 months, regardless of whetherglucocorticoids, immunosuppressive drugs, azathioprine, or other drug treatmentsaccording to MBMCrohn - Version 1.0 from 06.12.2019 Page 7 Guideline
Signed declaration of consent

Exclusion

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 psychologicalinterventions

Study Design

July 01, 2020

March 31, 2022

Study 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.

Connect with a study center

Sozialstiftung Bamberg, Klinik für Intergrative Medizin
Bamberg, Bayern 96049
Germany
Site Not Available

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