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

MBMCrohn: Die Wirkung Eines Stressreduktion- Und Lebensstilmodifikations-programms Auf Die Lebensqualität Von Patienten Mit Morbus Crohn- Eine Machbarkeitsstudie

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Behavioral: lifestyle-modification; Behavioral: waiting control group

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bayern
    • Bamberg, Bayern, Germany, 96049
      • Sozialstiftung Bamberg, Klinik für Intergrative Medizin

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• 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 crohn's disease patients.
Active Comparator: waiting 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. After the follow-up measurement opportunity to participate in the program.	Behavioral: waiting 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
Recruitment success	Proportion of people responding to appeals for studies	week 48
Willingness to participate	Proportion of people which actually agreed in relation to the proportion of people which responded to the appeal.	week 48
Attendance	Proportion of people which actually attend the study	week 48
Loss of participants over the study period	Proportion of people who quit during the study	week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-specific quality of life by IBD-Q	Inflammatory Bowel Disease Questionnaire (IBD-Q), Recording on 7-point Likert scale, high values mean good, low values a reduced quality of life (1=worst score, 7=best score)	week 0
Disease-specific quality of life by IBD-Q	Inflammatory Bowel Disease Questionnaire (IBD-Q), Recording on 7-point Likert scale, high values mean good, low values a reduced quality of life (1=worst score, 7=best score)	week 12
Disease-specific quality of life by IBD-Q	Inflammatory Bowel Disease Questionnaire (IBD-Q), Recording on 7-point Likert scale, high values mean good, low values a reduced quality of life (1=worst score, 7=best score)	week 36
Disease-specific quality of life by IBD-Q	Inflammatory Bowel Disease Questionnaire (IBD-Q), Recording on 7-point Likert scale, high values mean good, low values a reduced quality of life (1=worst score, 7=best score)	week 48
Generic quality of life by SF-36	Short Form Health 36 (SF-36) shows health-related quality of life, 36 items in 8 categories, 25% of the items must be filled in per category for evaluation. Lower sum score correlates with lower quality of life; higher sum score correlates with better quality of life.	week 0
Generic quality of life by SF 36	Short Form Health 36 (SF-36) shows health-related quality of life, 36 items in 8 categories, 25% of the items must be filled in per category for evaluation. Lower sum score correlates with lower quality of life; higher sum score correlates with better quality of life.	week 12
Generic quality of life by SF36	Short Form Health 36 (SF-36) shows health-related quality of life, 36 items in 8 categories, 25% of the items must be filled in per category for evaluation. Lower sum score correlates with lower quality of life; higher sum score correlates with better quality of life.	week 36
Generic quality of life by SF36	Short Form Health 36 (SF-36) shows health-related quality of life, 36 items in 8 categories, 25% of the items must be filled in per category for evaluation. Lower sum score correlates with lower quality of life; higher sum score correlates with better quality of life.	week 48
Disease activity 2 by BHI	Harvey-Bradshaw Index - HBI is used to assess the degree of illness in individuals with Crohn's disease. The highest possible sum is 30 points and indicates a severe course of disease. A lower sum than 5 points indicates a clinical remission.	week 0
Disease activity by HBI	Harvey-Bradshaw Index - HBI is used to assess the degree of illness in individuals with Crohn's disease. The highest possible sum is 30 points and indicates a severe course of disease. A lower sum than 5 points indicates a clinical remission.	week 12
Disease activity by HBI	Harvey-Bradshaw Index - HBI is used to assess the degree of illness in individuals with Crohn's disease. The highest possible sum is 30 points and indicates a severe course of disease. A lower sum than 5 points indicates a clinical remission.	week 36
Disease activity by HBI	Harvey-Bradshaw Index - HBI is used to assess the degree of illness in individuals with Crohn's disease. The highest possible sum is 30 points and indicates a severe course of disease. A lower sum than 5 points indicates a clinical remission.	week 48
Anxiety and depression by HADS	Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. high scores indicate depressivness and anxiety.	week 0
Anxiety and depression by HADS	Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. high scores indicate depressivness and anxiety.	week 12
Anxiety and depression by HADS	Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. high scores indicate depressivness and anxiety.	week 36
Anxiety and depression by HADS	Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. high scores indicate depressivness and anxiety.	week 48
Perceived stress by PSS	Perceived Stress Scale (PSS), Rating on a five-step scale from 1 (=never) to 5 (=very often), high stress is assumed from a total score of 20 points	week 0
Perceived stress by PSS	Perceived Stress Scale (PSS), Rating on a five-step scale from 1 (=never) to 5(=very often), high stress is assumed from a total score of 20 points	week 12
Perceived stress by PSS	Perceived Stress Scale (PSS), Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points	week 36
Perceived stress by PSS	Perceived Stress Scale (PSS), Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points	week 48
Coping strategies by COPE	Coping Orientations to problems experienced Scale (COPE), total values of each scale vary between 2 (minimum) and 8 (maximum). Higher values indicate increased use of the specific coping strategy	week 0
Coping strategies by COPE	Coping Orientations to problems experienced Scale (COPE), total values of each scale vary between 2 (minimum) and 8 (maximum). Higher values indicate increased use of the specific coping strategy	week 12
Coping strategies by COPE	Coping Orientations to problems experienced Scale (COPE), total values of each scale vary between 2 (minimum) and 8 (maximum). Higher values indicate increased use of the specific coping strategy	week 36
Coping strategies by COPE	Coping Orientations to problems experienced Scale (COPE), total values of each scale vary between 2 (minimum) and 8 (maximum). Higher values indicate increased use of the specific coping strategy	week 48
Flourishing by FS-D	Flourishing Scale (FS-D), total value of the scale vary between 8 (minimum) and 56 (maximum). A high value corresponds to a person with many psychological resources and strengths.	week 0
Flourishing by FS-D	Flourishing Scale (FS-D), total value of the scale vary between 8 (minimum) and 56 (maximum). A high value corresponds to a person with many psychological resources and strengths.	week 12
Flourishing by FS-D	Flourishing Scale (FS-D), total value of the scale vary between 8 (minimum) and 56 (maximum). A high value corresponds to a person with many psychological resources and strengths.	week 36
Flourishing by FS-D	Flourishing Scale (FS-D), total value of the scale vary between 8 (minimum) and 56 (maximum). A high value corresponds to a person with many psychological resources and strengths.	week 48
Core Self-Evaluation by CSES	Core Self-Evaluation (CSES), 12 items on five-point Likert scale, 1 indicates disagreement and 5 indicates full agreement. High scores on the CSES represents a positive, confident, and self-efficacious person	week 0
Core Self-Evaluation by CSES	Core Self-Evaluation (CSES), 12 items on five-point Likert scale, 1 indicates disagreement and 5 indicates full agreement. High scores on the CSES represents a positive, confident, and self-efficacious person	week 12
Core Self-Evaluation by CSES	Core Self-Evaluation (CSES), 12 items on five-point Likert scale, 1 indicates disagreement and 5 indicates full agreement. High scores on the CSES represents a positive, confident, and self-efficacious person	week 36
Core Self-Evaluation by CSES	Core Self-Evaluation (CSES), 12 items on five-point Likert scale, 1 indicates disagreement and 5 indicates full agreement. High scores on the CSES represents a positive, confident, and self-efficacious person	week 48
CRP (C-reactive protein)	Determination of CRP in the blood	week 0
CRP (C-reactive protein)	Determination of CRP in the blood	week 12
CRP (C-reactive protein)	Determination of CRP in the blood	week 36
CRP (C-reactive protein)	Determination of CRP in the blood	week 48
BSG (blood cell sedimentation rate)	Determination of BSG in the blood	week 0
BSG (blood cell sedimentation rate)	Determination of BSG in the blood	week 12
BSG (blood cell sedimentation rate)	Determination of BSG in the blood	week 36
BSG (blood cell sedimentation rate)	Determination of BSG in the blood	week 48
creatinin	Determination of creatin in the blood	week 0
creatinin	Determination of creatin in the blood	week 12
creatinin	Determination of creatin in the blood	week 36
creatinin	Determination of creatin in the blood	week 48
lymphocyte (T-cell) profiling	Determination of lymphocyte (T-cell) profiling in the blood	week 0
lymphocyte (T-cell) profiling	Determination of lymphocyte (T-cell) profiling in the blood	week 12
lymphocyte (T-cell) profiling	Determination of lymphocyte (T-cell) profiling in the blood	week 36
calprotectin	Determination of calprotectin in the stool	week 0
calprotectin	Determination of calprotectin in the stool	week 12
calprotectin	Determination of calprotectin in the stool	week 36
calprotectin	Determination of calprotectin in the stool	week 48
lactoferrin	Determination of lactoferrin in the stool	week 0
lactoferrin	Determination of lactoferrin in the stool	week 12
lactoferrin	Determination of lactoferrin in the stool	week 36
lactoferrin	Determination of lactoferrin in the stool	week 48
(PMN)-elastase	Determination of (PMN)-elastase in the stool	week 0
(PMN)-elastase	Determination of (PMN)-elastase in the stool	week 12
(PMN)-elastase	Determination of (PMN)-elastase in the stool	week 36
(PMN)-elastase	Determination of (PMN)-elastase in the stool	week 48
Human beta-defensin-2 (hBD-2)	Determination of hBD-2 in the stool	week 0
Human beta-defensin-2 (hBD-2)	Determination of hBD-2 in the stool	week 12
Human beta-defensin-2 (hBD-2)	Determination of hBD-2 in the stool	week 36
Human beta-defensin-2 (hBD-2)	Determination of hBD-2 in the stool	week 48
zonulin	Determination of zonulin in the stool	week 0
zonulin	Determination of zonulin in the stool	week 12
zonulin	Determination of zonulin in the stool	week 36
zonulin	Determination of zonulin in the stool	week 48
alpha-1-antitrypsin	Determination of alpha-antitrypsin in the stool	week 0
alpha-1- antitrypsin	Determination of alpha-antitrypsin in the stool	week 12
alpha-1-antitrypsin	Determination of alpha-antitrypsin in the stool	week 36
alpha-1-antitrypsin	Determination of alpha-antitrypsin in the stool	week 48
intestinal microbiome	Determination of intestinal microbiome	week 0
intestinal microbiome	Determination of intestinal microbiome	week 36
Intestinal permeability	confocal laser endomircoscopy	week 0
cortisol	Determination of cortisol during Trier Social Stress Test at 4 points in time in the afternoon (right before, right after, 10 minutes after and 60 minutes after the Trier Social Stress Test)	week 12
ACTH	Determination of ACTH during Trier Social Stress Test at 4 points in time in the afternoon (right before, right after, 10 minutes after and 60 minutes after the Trier Social Stress Test)	week 12
prolactin levels	Determination of prolactin levels during Trier Social Stress Test at 4 points in time in the afternoon (right before, right after, 10 minutes after and 60 minutes after the Trier Social Stress Test)	week 12
glucocorticoid and β-adrenergic regulation of IL-8 and IL-10	Determination of glucocorticoid and β-adrenergic regulation of IL-8 and IL-10 during Trier Social Stress Test at 4 points in time in the afternoon (right before, right after, 10 minutes after and 60 minutes after the Trier Social Stress Test)	week 12
TNF-α production by peripheral blood cells	Determination of TNF-α production by peripheral blood cells during Trier Social Stress Test at 4 points in time in the afternoon (right before, right after, 10 minutes after and 60 minutes after the Trier Social Stress Test)	week 12
heart rate	Determination of heart rate during Trier Social Stress Test at 4 points in time in the afternoon (right before, right after, 10 minutes after and 60 minutes after the Trier Social Stress Test)	week 12
blood pressure systolic and diastolic	Determination of blood pressure (systolic and diastolic) during Trier Social Stress Test at 4 points in time in the afternoon (right before, right after, 10 minutes after and 60 minutes after the Trier Social Stress Test)	week 12
STAI-S	Determination of STAI-S during Trier Social Stress Test at 4 points in time in the afternoon (right before, right after, 10 minutes after and 60 minutes after the Trier Social Stress Test)	week 12
Adverse events	all adverse events	week 12
Adverse events	all adverse events	week 36
Adverse events	all adverse events	week 48
qualitatives Interview	guideline oriented qualitative interview about the influence of the disease on the patients' everyday life, experience with the programme offered, effects of the intervention on the disease, implementation of the intervention in everyday life	week 36
age (questionnaire)	age in years	week 0
sex (questionnaire)	identification of the gender (male/female)	week 0
weight	weight in kilograms	week 0
body height	body height in meters	week 0
School career (questionnaire)	identification of the school career	week 0
job (questionnaire)	identification of the actual job	week 0
professional career (questionnaire)	identification of job qualifications	week 0
marital status (questionnaire)	identification of the marital status (married/divorced/single/widowed)	week 0
occupation (questionnaire)	identification of the type of occupation	week 0

Collaborators and Investigators

• Sponsor: Jost Langhorst
• Collaborators: Wuerzburg University Hospital; University of Wuerzburg; Sozialstiftung Bamberg; Bavarian State Ministry of Health and Care
• Investigators: Study Director: Jost Langhorst, Prof., Sozialstiftung Bamberg

Publications and helpful links

General Publications

• Bauer N, Loffler C, Oznur O, Uecker C, Keil T, Langhorst J. Mind-body-medicine and comprehensive lifestyle-modification in patients with Crohn's disease-Feasibility of a randomized controlled trial under pandemic circumstances. Front Integr Neurosci. 2022 Aug 23;16:960301. doi: 10.3389/fnint.2022.960301. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 19096

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No