Randomized Controlled Trial of Stress Reduction and Lifestyle Modification for Ulcerative Colitis
MBMCol
Randomized Controlled Trial on the Effect of Stress Reduction and Lifestyle Modification on Disease Activity in Ulcerative Colitis
1 other identifier
interventional
92
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedMay 10, 2017
May 1, 2017
3.6 years
February 10, 2016
May 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-specific quality of life
Inflammatory Bowel Disease Questionnaire (IBD-Q)
12 weeks
Secondary Outcomes (75)
Disease-specific quality of life
48 weeks
Disease-specific quality of life
60 weeks
Disease-specific quality of life
108 weeks
Disease activity
12 weeks
Disease activity
12 weeks
- +70 more secondary outcomes
Study Arms (2)
lifestyle-modification
EXPERIMENTALOnce a week for 10 weeks with a circumference of 60 hours with mindfulness-based stress reduction and further process of the Mind / body medicine.
control group
ACTIVE COMPARATORA 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kliniken Essen-Mitte, Knappschafts Krankenhaus
Essen, North Rhine-Westphalia, 45276, Germany
Related Publications (2)
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PMID: 40243391DERIVEDSchlee C, Uecker C, Bauer N, Koch AK, Langhorst J. Multimodal stress reduction and lifestyle modification program for patients with ulcerative colitis: a qualitative study. BMC Complement Med Ther. 2022 Mar 8;22(1):60. doi: 10.1186/s12906-021-03478-w.
PMID: 35260152DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jost Langhorst, Prof. Dr. med.
Kliniken Essen-Mitte
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical vice director
Study Record Dates
First Submitted
February 10, 2016
First Posted
March 29, 2016
Study Start
March 1, 2016
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
May 10, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share