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

Primary Purpose

Crohn Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
lifestyle-modification
waiting control group
Sponsored by
Jost Langhorst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sozialstiftung Bamberg, Klinik für Intergrative Medizin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

lifestyle-modification

waiting control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recruitment success
Proportion of people responding to appeals for studies
Willingness to participate
Proportion of people which actually agreed in relation to the proportion of people which responded to the appeal.
Attendance
Proportion of people which actually attend the study
Loss of participants over the study period
Proportion of people who quit during the study

Secondary Outcome Measures

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)
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)
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)
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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
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
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
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.
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.
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.
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.
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
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
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
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
CRP (C-reactive protein)
Determination of CRP in the blood
CRP (C-reactive protein)
Determination of CRP in the blood
CRP (C-reactive protein)
Determination of CRP in the blood
CRP (C-reactive protein)
Determination of CRP in the blood
BSG (blood cell sedimentation rate)
Determination of BSG in the blood
BSG (blood cell sedimentation rate)
Determination of BSG in the blood
BSG (blood cell sedimentation rate)
Determination of BSG in the blood
BSG (blood cell sedimentation rate)
Determination of BSG in the blood
creatinin
Determination of creatin in the blood
creatinin
Determination of creatin in the blood
creatinin
Determination of creatin in the blood
creatinin
Determination of creatin in the blood
lymphocyte (T-cell) profiling
Determination of lymphocyte (T-cell) profiling in the blood
lymphocyte (T-cell) profiling
Determination of lymphocyte (T-cell) profiling in the blood
lymphocyte (T-cell) profiling
Determination of lymphocyte (T-cell) profiling in the blood
calprotectin
Determination of calprotectin in the stool
calprotectin
Determination of calprotectin in the stool
calprotectin
Determination of calprotectin in the stool
calprotectin
Determination of calprotectin in the stool
lactoferrin
Determination of lactoferrin in the stool
lactoferrin
Determination of lactoferrin in the stool
lactoferrin
Determination of lactoferrin in the stool
lactoferrin
Determination of lactoferrin in the stool
(PMN)-elastase
Determination of (PMN)-elastase in the stool
(PMN)-elastase
Determination of (PMN)-elastase in the stool
(PMN)-elastase
Determination of (PMN)-elastase in the stool
(PMN)-elastase
Determination of (PMN)-elastase in the stool
Human beta-defensin-2 (hBD-2)
Determination of hBD-2 in the stool
Human beta-defensin-2 (hBD-2)
Determination of hBD-2 in the stool
Human beta-defensin-2 (hBD-2)
Determination of hBD-2 in the stool
Human beta-defensin-2 (hBD-2)
Determination of hBD-2 in the stool
zonulin
Determination of zonulin in the stool
zonulin
Determination of zonulin in the stool
zonulin
Determination of zonulin in the stool
zonulin
Determination of zonulin in the stool
alpha-1-antitrypsin
Determination of alpha-antitrypsin in the stool
alpha-1- antitrypsin
Determination of alpha-antitrypsin in the stool
alpha-1-antitrypsin
Determination of alpha-antitrypsin in the stool
alpha-1-antitrypsin
Determination of alpha-antitrypsin in the stool
intestinal microbiome
Determination of intestinal microbiome
intestinal microbiome
Determination of intestinal microbiome
Intestinal permeability
confocal laser endomircoscopy
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)
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)
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)
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)
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)
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)
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)
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)
Adverse events
all adverse events
Adverse events
all adverse events
Adverse events
all adverse events
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
age (questionnaire)
age in years
sex (questionnaire)
identification of the gender (male/female)
weight
weight in kilograms
body height
body height in meters
School career (questionnaire)
identification of the school career
job (questionnaire)
identification of the actual job
professional career (questionnaire)
identification of job qualifications
marital status (questionnaire)
identification of the marital status (married/divorced/single/widowed)
occupation (questionnaire)
identification of the type of occupation

Full Information

First Posted
August 11, 2020
Last Updated
November 14, 2022
Sponsor
Jost Langhorst
Collaborators
Sozialstiftung Bamberg, University of Wuerzburg, Wuerzburg University Hospital, Bavarian State Ministry of Health and Care
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1. Study Identification

Unique Protocol Identification Number
NCT05182645
Brief Title
Effect of a Stress Reduction and Lifestyle Modification Programme on the Quality of Life of Crohn's Disease Patients
Acronym
MBMCrohn
Official Title
MBMCrohn: Die Wirkung Eines Stressreduktion- Und Lebensstilmodifikations-programms Auf Die Lebensqualität Von Patienten Mit Morbus Crohn- Eine Machbarkeitsstudie
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jost Langhorst
Collaborators
Sozialstiftung Bamberg, University of Wuerzburg, Wuerzburg University Hospital, Bavarian State Ministry of Health and Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Waiting Control Group Design
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lifestyle-modification
Arm Type
Experimental
Arm Description
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.
Arm Title
waiting control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
lifestyle-modification
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
waiting control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment success
Description
Proportion of people responding to appeals for studies
Time Frame
week 48
Title
Willingness to participate
Description
Proportion of people which actually agreed in relation to the proportion of people which responded to the appeal.
Time Frame
week 48
Title
Attendance
Description
Proportion of people which actually attend the study
Time Frame
week 48
Title
Loss of participants over the study period
Description
Proportion of people who quit during the study
Time Frame
week 48
Secondary Outcome Measure Information:
Title
Disease-specific quality of life by IBD-Q
Description
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)
Time Frame
week 0
Title
Disease-specific quality of life by IBD-Q
Description
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)
Time Frame
week 12
Title
Disease-specific quality of life by IBD-Q
Description
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)
Time Frame
week 36
Title
Disease-specific quality of life by IBD-Q
Description
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)
Time Frame
week 48
Title
Generic quality of life by SF-36
Description
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.
Time Frame
week 0
Title
Generic quality of life by SF 36
Description
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.
Time Frame
week 12
Title
Generic quality of life by SF36
Description
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.
Time Frame
week 36
Title
Generic quality of life by SF36
Description
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.
Time Frame
week 48
Title
Disease activity 2 by BHI
Description
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.
Time Frame
week 0
Title
Disease activity by HBI
Description
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.
Time Frame
week 12
Title
Disease activity by HBI
Description
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.
Time Frame
week 36
Title
Disease activity by HBI
Description
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.
Time Frame
week 48
Title
Anxiety and depression by HADS
Description
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.
Time Frame
week 0
Title
Anxiety and depression by HADS
Description
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.
Time Frame
week 12
Title
Anxiety and depression by HADS
Description
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.
Time Frame
week 36
Title
Anxiety and depression by HADS
Description
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.
Time Frame
week 48
Title
Perceived stress by PSS
Description
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
Time Frame
week 0
Title
Perceived stress by PSS
Description
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
Time Frame
week 12
Title
Perceived stress by PSS
Description
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
Time Frame
week 36
Title
Perceived stress by PSS
Description
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
Time Frame
week 48
Title
Coping strategies by COPE
Description
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
Time Frame
week 0
Title
Coping strategies by COPE
Description
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
Time Frame
week 12
Title
Coping strategies by COPE
Description
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
Time Frame
week 36
Title
Coping strategies by COPE
Description
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
Time Frame
week 48
Title
Flourishing by FS-D
Description
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.
Time Frame
week 0
Title
Flourishing by FS-D
Description
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.
Time Frame
week 12
Title
Flourishing by FS-D
Description
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.
Time Frame
week 36
Title
Flourishing by FS-D
Description
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.
Time Frame
week 48
Title
Core Self-Evaluation by CSES
Description
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
Time Frame
week 0
Title
Core Self-Evaluation by CSES
Description
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
Time Frame
week 12
Title
Core Self-Evaluation by CSES
Description
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
Time Frame
week 36
Title
Core Self-Evaluation by CSES
Description
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
Time Frame
week 48
Title
CRP (C-reactive protein)
Description
Determination of CRP in the blood
Time Frame
week 0
Title
CRP (C-reactive protein)
Description
Determination of CRP in the blood
Time Frame
week 12
Title
CRP (C-reactive protein)
Description
Determination of CRP in the blood
Time Frame
week 36
Title
CRP (C-reactive protein)
Description
Determination of CRP in the blood
Time Frame
week 48
Title
BSG (blood cell sedimentation rate)
Description
Determination of BSG in the blood
Time Frame
week 0
Title
BSG (blood cell sedimentation rate)
Description
Determination of BSG in the blood
Time Frame
week 12
Title
BSG (blood cell sedimentation rate)
Description
Determination of BSG in the blood
Time Frame
week 36
Title
BSG (blood cell sedimentation rate)
Description
Determination of BSG in the blood
Time Frame
week 48
Title
creatinin
Description
Determination of creatin in the blood
Time Frame
week 0
Title
creatinin
Description
Determination of creatin in the blood
Time Frame
week 12
Title
creatinin
Description
Determination of creatin in the blood
Time Frame
week 36
Title
creatinin
Description
Determination of creatin in the blood
Time Frame
week 48
Title
lymphocyte (T-cell) profiling
Description
Determination of lymphocyte (T-cell) profiling in the blood
Time Frame
week 0
Title
lymphocyte (T-cell) profiling
Description
Determination of lymphocyte (T-cell) profiling in the blood
Time Frame
week 12
Title
lymphocyte (T-cell) profiling
Description
Determination of lymphocyte (T-cell) profiling in the blood
Time Frame
week 36
Title
calprotectin
Description
Determination of calprotectin in the stool
Time Frame
week 0
Title
calprotectin
Description
Determination of calprotectin in the stool
Time Frame
week 12
Title
calprotectin
Description
Determination of calprotectin in the stool
Time Frame
week 36
Title
calprotectin
Description
Determination of calprotectin in the stool
Time Frame
week 48
Title
lactoferrin
Description
Determination of lactoferrin in the stool
Time Frame
week 0
Title
lactoferrin
Description
Determination of lactoferrin in the stool
Time Frame
week 12
Title
lactoferrin
Description
Determination of lactoferrin in the stool
Time Frame
week 36
Title
lactoferrin
Description
Determination of lactoferrin in the stool
Time Frame
week 48
Title
(PMN)-elastase
Description
Determination of (PMN)-elastase in the stool
Time Frame
week 0
Title
(PMN)-elastase
Description
Determination of (PMN)-elastase in the stool
Time Frame
week 12
Title
(PMN)-elastase
Description
Determination of (PMN)-elastase in the stool
Time Frame
week 36
Title
(PMN)-elastase
Description
Determination of (PMN)-elastase in the stool
Time Frame
week 48
Title
Human beta-defensin-2 (hBD-2)
Description
Determination of hBD-2 in the stool
Time Frame
week 0
Title
Human beta-defensin-2 (hBD-2)
Description
Determination of hBD-2 in the stool
Time Frame
week 12
Title
Human beta-defensin-2 (hBD-2)
Description
Determination of hBD-2 in the stool
Time Frame
week 36
Title
Human beta-defensin-2 (hBD-2)
Description
Determination of hBD-2 in the stool
Time Frame
week 48
Title
zonulin
Description
Determination of zonulin in the stool
Time Frame
week 0
Title
zonulin
Description
Determination of zonulin in the stool
Time Frame
week 12
Title
zonulin
Description
Determination of zonulin in the stool
Time Frame
week 36
Title
zonulin
Description
Determination of zonulin in the stool
Time Frame
week 48
Title
alpha-1-antitrypsin
Description
Determination of alpha-antitrypsin in the stool
Time Frame
week 0
Title
alpha-1- antitrypsin
Description
Determination of alpha-antitrypsin in the stool
Time Frame
week 12
Title
alpha-1-antitrypsin
Description
Determination of alpha-antitrypsin in the stool
Time Frame
week 36
Title
alpha-1-antitrypsin
Description
Determination of alpha-antitrypsin in the stool
Time Frame
week 48
Title
intestinal microbiome
Description
Determination of intestinal microbiome
Time Frame
week 0
Title
intestinal microbiome
Description
Determination of intestinal microbiome
Time Frame
week 36
Title
Intestinal permeability
Description
confocal laser endomircoscopy
Time Frame
week 0
Title
cortisol
Description
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)
Time Frame
week 12
Title
ACTH
Description
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)
Time Frame
week 12
Title
prolactin levels
Description
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)
Time Frame
week 12
Title
glucocorticoid and β-adrenergic regulation of IL-8 and IL-10
Description
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)
Time Frame
week 12
Title
TNF-α production by peripheral blood cells
Description
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)
Time Frame
week 12
Title
heart rate
Description
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)
Time Frame
week 12
Title
blood pressure systolic and diastolic
Description
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)
Time Frame
week 12
Title
STAI-S
Description
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)
Time Frame
week 12
Title
Adverse events
Description
all adverse events
Time Frame
week 12
Title
Adverse events
Description
all adverse events
Time Frame
week 36
Title
Adverse events
Description
all adverse events
Time Frame
week 48
Title
qualitatives Interview
Description
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
Time Frame
week 36
Title
age (questionnaire)
Description
age in years
Time Frame
week 0
Title
sex (questionnaire)
Description
identification of the gender (male/female)
Time Frame
week 0
Title
weight
Description
weight in kilograms
Time Frame
week 0
Title
body height
Description
body height in meters
Time Frame
week 0
Title
School career (questionnaire)
Description
identification of the school career
Time Frame
week 0
Title
job (questionnaire)
Description
identification of the actual job
Time Frame
week 0
Title
professional career (questionnaire)
Description
identification of job qualifications
Time Frame
week 0
Title
marital status (questionnaire)
Description
identification of the marital status (married/divorced/single/widowed)
Time Frame
week 0
Title
occupation (questionnaire)
Description
identification of the type of occupation
Time Frame
week 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jost Langhorst, Prof.
Organizational Affiliation
Sozialstiftung Bamberg
Official's Role
Study Director
Facility Information:
Facility Name
Sozialstiftung Bamberg, Klinik für Intergrative Medizin
City
Bamberg
State/Province
Bayern
ZIP/Postal Code
96049
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36081609
Citation
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.
Results Reference
derived

Learn more about this trial

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

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