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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Crohn Disease

Intervention / Treatment
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* Behavioral: lifestyle-modification
* Behavioral: waiting control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Waiting Control Group Design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lifestyle-modification<br>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<br>* 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.<br>|
| Active Comparator: waiting control group<br>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<br>* 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.<br>|

What is the study measuring?
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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 |