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

Crohn Disease Clinical Trial

— MBMCrohn  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05182645
• Other study ID #: 19096
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: November 2022
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Sozialstiftung Bamberg, Klinik für Intergrative Medizin	Bamberg	Bayern

Sponsors (5)

Lead Sponsor	Collaborator
Jost Langhorst	Bavarian State Ministry of Health and Care, Sozialstiftung Bamberg, University of Wuerzburg, Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment success	Proportion of people responding to appeals for studies	week 48
Primary	Willingness to participate	Proportion of people which actually agreed in relation to the proportion of people which responded to the appeal.	week 48
Primary	Attendance	Proportion of people which actually attend the study	week 48
Primary	Loss of participants over the study period	Proportion of people who quit during the study	week 48
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	CRP (C-reactive protein)	Determination of CRP in the blood	week 0
Secondary	CRP (C-reactive protein)	Determination of CRP in the blood	week 12
Secondary	CRP (C-reactive protein)	Determination of CRP in the blood	week 36
Secondary	CRP (C-reactive protein)	Determination of CRP in the blood	week 48
Secondary	BSG (blood cell sedimentation rate)	Determination of BSG in the blood	week 0
Secondary	BSG (blood cell sedimentation rate)	Determination of BSG in the blood	week 12
Secondary	BSG (blood cell sedimentation rate)	Determination of BSG in the blood	week 36
Secondary	BSG (blood cell sedimentation rate)	Determination of BSG in the blood	week 48
Secondary	creatinin	Determination of creatin in the blood	week 0
Secondary	creatinin	Determination of creatin in the blood	week 12
Secondary	creatinin	Determination of creatin in the blood	week 36
Secondary	creatinin	Determination of creatin in the blood	week 48
Secondary	lymphocyte (T-cell) profiling	Determination of lymphocyte (T-cell) profiling in the blood	week 0
Secondary	lymphocyte (T-cell) profiling	Determination of lymphocyte (T-cell) profiling in the blood	week 12
Secondary	lymphocyte (T-cell) profiling	Determination of lymphocyte (T-cell) profiling in the blood	week 36
Secondary	calprotectin	Determination of calprotectin in the stool	week 0
Secondary	calprotectin	Determination of calprotectin in the stool	week 12
Secondary	calprotectin	Determination of calprotectin in the stool	week 36
Secondary	calprotectin	Determination of calprotectin in the stool	week 48
Secondary	lactoferrin	Determination of lactoferrin in the stool	week 0
Secondary	lactoferrin	Determination of lactoferrin in the stool	week 12
Secondary	lactoferrin	Determination of lactoferrin in the stool	week 36
Secondary	lactoferrin	Determination of lactoferrin in the stool	week 48
Secondary	(PMN)-elastase	Determination of (PMN)-elastase in the stool	week 0
Secondary	(PMN)-elastase	Determination of (PMN)-elastase in the stool	week 12
Secondary	(PMN)-elastase	Determination of (PMN)-elastase in the stool	week 36
Secondary	(PMN)-elastase	Determination of (PMN)-elastase in the stool	week 48
Secondary	Human beta-defensin-2 (hBD-2)	Determination of hBD-2 in the stool	week 0
Secondary	Human beta-defensin-2 (hBD-2)	Determination of hBD-2 in the stool	week 12
Secondary	Human beta-defensin-2 (hBD-2)	Determination of hBD-2 in the stool	week 36
Secondary	Human beta-defensin-2 (hBD-2)	Determination of hBD-2 in the stool	week 48
Secondary	zonulin	Determination of zonulin in the stool	week 0
Secondary	zonulin	Determination of zonulin in the stool	week 12
Secondary	zonulin	Determination of zonulin in the stool	week 36
Secondary	zonulin	Determination of zonulin in the stool	week 48
Secondary	alpha-1-antitrypsin	Determination of alpha-antitrypsin in the stool	week 0
Secondary	alpha-1- antitrypsin	Determination of alpha-antitrypsin in the stool	week 12
Secondary	alpha-1-antitrypsin	Determination of alpha-antitrypsin in the stool	week 36
Secondary	alpha-1-antitrypsin	Determination of alpha-antitrypsin in the stool	week 48
Secondary	intestinal microbiome	Determination of intestinal microbiome	week 0
Secondary	intestinal microbiome	Determination of intestinal microbiome	week 36
Secondary	Intestinal permeability	confocal laser endomircoscopy	week 0
Secondary	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
Secondary	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
Secondary	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
Secondary	glucocorticoid and ß-adrenergic regulation of IL-8 and IL-10	Determination of glucocorticoid and ß-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
Secondary	TNF-a production by peripheral blood cells	Determination of TNF-a 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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events	all adverse events	week 12
Secondary	Adverse events	all adverse events	week 36
Secondary	Adverse events	all adverse events	week 48
Secondary	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
Secondary	age (questionnaire)	age in years	week 0
Secondary	sex (questionnaire)	identification of the gender (male/female)	week 0
Secondary	weight	weight in kilograms	week 0
Secondary	body height	body height in meters	week 0
Secondary	School career (questionnaire)	identification of the school career	week 0
Secondary	job (questionnaire)	identification of the actual job	week 0
Secondary	professional career (questionnaire)	identification of job qualifications	week 0
Secondary	marital status (questionnaire)	identification of the marital status (married/divorced/single/widowed)	week 0
Secondary	occupation (questionnaire)	identification of the type of occupation	week 0