Crohn Disease
Conditions
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.
Interventions
BEHAVIORALlifestyle-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.
BEHAVIORALwaiting 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.
Sponsors
Sozialstiftung Bamberg
University of Wuerzburg
Wuerzburg University Hospital
Bavarian State Ministry of Health and Care
Jost Langhorst
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Waiting Control Group Design
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment success | week 48 | Proportion of people responding to appeals for studies |
| Willingness to participate | week 48 | Proportion of people which actually agreed in relation to the proportion of people which responded to the appeal. |
| Attendance | week 48 | Proportion of people which actually attend the study |
| Loss of participants over the study period | week 48 | Proportion of people who quit during the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generic quality of life by SF 36 | week 12 | 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 | week 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. |
| Disease activity 2 by BHI | week 0 | 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 | week 12 | 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. |
| lymphocyte (T-cell) profiling | week 0 | Determination of lymphocyte (T-cell) profiling in the blood |
| calprotectin | week 0 | Determination of calprotectin in the stool |
| Anxiety and depression by HADS | week 0 | 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 | week 0 | 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 | week 0 | 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 | week 0 | 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 | week 0 | 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) | week 0 | Determination of CRP in the blood |
| lactoferrin | week 0 | Determination of lactoferrin in the stool |
| (PMN)-elastase | week 0 | Determination of (PMN)-elastase in the stool |
| Human beta-defensin-2 (hBD-2) | week 0 | Determination of hBD-2 in the stool |
| zonulin | week 0 | Determination of zonulin in the stool |
| alpha-1-antitrypsin | week 0 | Determination of alpha-antitrypsin in the stool |
| alpha-1- antitrypsin | week 12 | Determination of alpha-antitrypsin in the stool |
| intestinal microbiome | week 0 | Determination of intestinal microbiome |
| Intestinal permeability | week 0 | confocal laser endomircoscopy |
| cortisol | week 12 | 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 | week 12 | 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 | week 12 | 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 | week 12 | 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 | week 12 | 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 | week 12 | 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 | week 12 | 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 | week 12 | 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 | week 12 | all adverse events |
| qualitatives Interview | week 36 | 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) | week 0 | age in years |
| sex (questionnaire) | week 0 | identification of the gender (male/female) |
| weight | week 0 | weight in kilograms |
| body height | week 0 | body height in meters |
| School career (questionnaire) | week 0 | identification of the school career |
| job (questionnaire) | week 0 | identification of the actual job |
| professional career (questionnaire) | week 0 | identification of job qualifications |
| BSG (blood cell sedimentation rate) | week 0 | Determination of BSG in the blood |
| occupation (questionnaire) | week 0 | identification of the type of occupation |
| marital status (questionnaire) | week 0 | identification of the marital status (married/divorced/single/widowed) |
| creatinin | week 0 | Determination of creatin in the blood |
| Disease-specific quality of life by IBD-Q | week 0 | 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 | week 0 | 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. |
Countries
Germany
Outcome results
None listed