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

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.

Study Overview

• Status: Unknown
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Behavioral: lifestyle-modification; Behavioral: Control group

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jost Langhorst, Prof. Dr. med.; Phone Number: 020117425012; Email: j.langhorst@kliniken-essen-mitte.de

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45276
      • Recruiting
      • Kliniken Essen-Mitte, Knappschafts Krankenhaus
      • Contact: Jost Langhorst, Prof. Dr.; Phone Number: 49-201-174 25012; Email: j.langhorst@kliniken-essen-mitte.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: lifestyle-modification; 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.	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.
ACTIVE_COMPARATOR: control group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-specific quality of life	Inflammatory Bowel Disease Questionnaire (IBD-Q)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events		12 weeks
Adverse events		48 weeks
C-reactive protein		12 weeks
Disease-specific quality of life	Inflammatory Bowel Disease Questionnaire (IBD-Q)	48 weeks
Disease-specific quality of life	Inflammatory Bowel Disease Questionnaire (IBD-Q)	60 weeks
Disease-specific quality of life	Inflammatory Bowel Disease Questionnaire (IBD-Q)	108 weeks
Disease activity	Mayo Disease Activity Index (Mayo Score)	12 weeks
Disease activity	Clinical Activity Index (CAI)	12 weeks
Disease activity	Mayo Disease Activity Index (Mayo Score)	48 weeks
Disease activity	Clinical Activity Index (CAI)	48 weeks
Disease activity	Mayo Disease Activity Index (Mayo Score)	60 weeks
Disease activity	Clinical Activity Index (CAI)	60 weeks
Disease activity	Mayo Disease Activity Index (Mayo Score)	108 weeks
Disease activity	Clinical Activity Index(CAI)	108 weeks
Endoscopic index	Endoscopic-Index (sigmoidoscopy)	12 weeks
Endoscopic index	Endoscopic-Index (sigmoidoscopy)	48 weeks
Endoscopic index	Endoscopic-Index (sigmoidoscopy))	60 weeks
Endoscopic index	Endoscopic-Index (sigmoidoscopy)	108 weeks
Histology	Riley Score	12 weeks
Histology	Riley Score	48 weeks
Histology	Riley Score	60 weeks
Histology	Riley Score	108 weeks
Generic quality of life	Short Form (SF) -36 (items) health survey	12 weeks
Generic quality of life	SF-36 health survey	48 weeks
Generic quality of life	SF-36 health survey	60 weeks
Generic quality of life	SF-36 health survey	108 weeks
Anxiety and depression	Hospital Anxiety and Depression Scale (HADS)	12 weeks
Anxiety and depression	Hospital Anxiety and Depression Scale (HADS)	48 weeks
Anxiety and depression	Hospital Anxiety and Depression Scale (HADS)	60 weeks
Anxiety and depression	Hospital Anxiety and Depression Scale (HADS)	108 weeks
Perceived stress	Perceived Stress Scale (PSS)	12 weeks
Perceived stress	Perceived Stress Scale (PSS)	48 weeks
Perceived stress	Perceived Stress Scale (PSS)	60 weeks
Perceived stress	Perceived Stress Scale (PSS)	108 weeks
Irritable Bowel Syndrome Symptoms	IBS Severity Scoring System (IBS-SSS)	12 weeks
Irritable Bowel Syndrome Symptoms	IBS Severity Scoring System (IBS-SSS)	48 weeks
Irritable Bowel Syndrome Symptoms	IBS Severity Scoring System (IBS-SSS)	60 weeks
Irritable Bowel Syndrome Symptoms	IBS Severity Scoring System (IBS-SSS)	108 weeks
Hemogram	leukocyte, hemoglobin, hematocrit, platelet	12 weeks
Hemogram	leukocyte, hemoglobin, hematocrit, platelet	48 weeks
Hemogram	leukocyte, hemoglobin, hematocrit, platelet	60 weeks
Hemogram	leukocyte, hemoglobin, hematocrit, platelet	108 weeks
Blood sedimentation rate		12 weeks
Blood sedimentation rate		48 weeks
Blood sedimentation rate		60 weeks
Blood sedimentation rate		108 weeks
C-reactive protein		48 weeks
C-reactive protein		60 weeks
C-reactive protein		108 weeks
faecal calprotectin		12 weeks
faecal calprotectin		48 weeks
faecal calprotectin		60 weeks
faecal calprotectin		108 weeks
faecal lactoferrin		12 weeks
faecal lactoferrin		48 weeks
faecal lactoferrin		60 weeks
faecal lactoferrin		108 weeks
faecal polymorphonuclear (PMN)-elastase	faecal polymorphonuclear elastase	12 weeks
faecal PMN-elastase	faecal polymorphonuclear elastase	48 weeks
faecal PMN-elastase	faecal polymorphonuclear elastase	60 weeks
faecal PMN-elastase	faecal polymorphonuclear elastase	108 weeks
faecal human beta-defensin-2 (hBD-2)		12 weeks
faecal hBD-2	human beta-defensin-2	48 weeks
faecal hBD-2	human beta-defensin-2	60 weeks
faecal hBD-2	human beta-defensin-2	108 weeks
Intestinal microbiota	High-throughput 16S ribosomal ribonucleic acid (rRNA) gene sequencing	12 weeks
Intestinal microbiota	High-throughput 16S rRNA gene sequencing	48 weeks
Intestinal microbiota	High-throughput 16S rRNA gene sequencing	60 weeks
Intestinal microbiota	High-throughput 16S rRNA gene sequencing	108 weeks
Intestinal permeability	LactoseMonitol	12 weeks
Intestinal permeability	LactoseMonitol	48 weeks
Intestinal permeability	LactoseMonitol	60 weeks
Intestinal permeability	LactoseMonitol	108 weeks
Adverse events		60 weeks
Adverse events		108 weeks

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Investigators: Principal Investigator: Jost Langhorst, Prof. Dr. med., Kliniken Essen-Mitte

Publications and helpful links

General Publications

• Schlee 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ANTICIPATED): October 1, 2019
• Study Completion (ANTICIPATED): October 1, 2019

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (ESTIMATE): March 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 15-6554-BO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO