An interventional study of lifestyle-modification and waiting control group in Crohn Disease, sponsored by Jost Langhorst. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-11-15.
Sponsored by Jost Langhorst · Not applicable, Interventional, and Treatment
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.
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 42 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Jost Langhorst is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
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.
Recruitment success
Proportion of people responding to appeals for studies
Time frame: week 48
Willingness to participate
Proportion of people which actually agreed in relation to the proportion of people which responded to the appeal.
Time frame: week 48
Attendance
Proportion of people which actually attend the study
Time frame: week 48
Loss of participants over the study period
Proportion of people who quit during the study
Time frame: week 48
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: week 48
CRP (C-reactive protein)
Determination of CRP in the blood
Time frame: week 0
CRP (C-reactive protein)
Determination of CRP in the blood
Time frame: week 12
CRP (C-reactive protein)
Determination of CRP in the blood
Time frame: week 36
CRP (C-reactive protein)
Determination of CRP in the blood
Time frame: week 48
BSG (blood cell sedimentation rate)
Determination of BSG in the blood
Time frame: week 0
BSG (blood cell sedimentation rate)
Determination of BSG in the blood
Time frame: week 12
BSG (blood cell sedimentation rate)
Determination of BSG in the blood
Time frame: week 36
BSG (blood cell sedimentation rate)
Determination of BSG in the blood
Time frame: week 48
creatinin
Determination of creatin in the blood
Time frame: week 0
creatinin
Determination of creatin in the blood
Time frame: week 12
creatinin
Determination of creatin in the blood
Time frame: week 36
creatinin
Determination of creatin in the blood
Time frame: week 48
lymphocyte (T-cell) profiling
Determination of lymphocyte (T-cell) profiling in the blood
Time frame: week 0
lymphocyte (T-cell) profiling
Determination of lymphocyte (T-cell) profiling in the blood
Time frame: week 12
lymphocyte (T-cell) profiling
Determination of lymphocyte (T-cell) profiling in the blood
Time frame: week 36
calprotectin
Determination of calprotectin in the stool
Time frame: week 0
calprotectin
Determination of calprotectin in the stool
Time frame: week 12
calprotectin
Determination of calprotectin in the stool
Time frame: week 36
calprotectin
Determination of calprotectin in the stool
Time frame: week 48
lactoferrin
Determination of lactoferrin in the stool
Time frame: week 0
lactoferrin
Determination of lactoferrin in the stool
Time frame: week 12
lactoferrin
Determination of lactoferrin in the stool
Time frame: week 36
lactoferrin
Determination of lactoferrin in the stool
Time frame: week 48
(PMN)-elastase
Determination of (PMN)-elastase in the stool
Time frame: week 0
(PMN)-elastase
Determination of (PMN)-elastase in the stool
Time frame: week 12
(PMN)-elastase
Determination of (PMN)-elastase in the stool
Time frame: week 36
(PMN)-elastase
Determination of (PMN)-elastase in the stool
Time frame: week 48
Human beta-defensin-2 (hBD-2)
Determination of hBD-2 in the stool
Time frame: week 0
Human beta-defensin-2 (hBD-2)
Determination of hBD-2 in the stool
Time frame: week 12
Human beta-defensin-2 (hBD-2)
Determination of hBD-2 in the stool
Time frame: week 36
Human beta-defensin-2 (hBD-2)
Determination of hBD-2 in the stool
Time frame: week 48
zonulin
Determination of zonulin in the stool
Time frame: week 0
zonulin
Determination of zonulin in the stool
Time frame: week 12
zonulin
Determination of zonulin in the stool
Time frame: week 36
zonulin
Determination of zonulin in the stool
Time frame: week 48
alpha-1-antitrypsin
Determination of alpha-antitrypsin in the stool
Time frame: week 0
alpha-1- antitrypsin
Determination of alpha-antitrypsin in the stool
Time frame: week 12
alpha-1-antitrypsin
Determination of alpha-antitrypsin in the stool
Time frame: week 36
alpha-1-antitrypsin
Determination of alpha-antitrypsin in the stool
Time frame: week 48
intestinal microbiome
Determination of intestinal microbiome
Time frame: week 0
intestinal microbiome
Determination of intestinal microbiome
Time frame: week 36
Intestinal permeability
confocal laser endomircoscopy
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: week 12
Adverse events
all adverse events
Time frame: week 12
Adverse events
all adverse events
Time frame: week 36
Adverse events
all adverse events
Time frame: 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
Time frame: week 36
age (questionnaire)
age in years
Time frame: week 0
sex (questionnaire)
identification of the gender (male/female)
Time frame: week 0
weight
weight in kilograms
Time frame: week 0
body height
body height in meters
Time frame: week 0
School career (questionnaire)
identification of the school career
Time frame: week 0
job (questionnaire)
identification of the actual job
Time frame: week 0
professional career (questionnaire)
identification of job qualifications
Time frame: week 0
marital status (questionnaire)
identification of the marital status (married/divorced/single/widowed)
Time frame: week 0
occupation (questionnaire)
identification of the type of occupation
Time frame: week 0
Plan to share: No
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Jost Langhorst