Effect of a Stress Reduction and Lifestyle Modification Programme on the Quality of Life of Crohn's Disease Patients
- Conditions
- Crohn Disease
- Interventions
- Behavioral: lifestyle-modificationBehavioral: waiting control group
- Registration Number
- NCT05182645
- Lead Sponsor
- Jost Langhorst
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lifestyle-modification lifestyle-modification 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. waiting control group waiting control group 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.
- Primary Outcome Measures
Name Time Method Recruitment success week 48 Proportion of people responding to appeals for studies
Attendance week 48 Proportion of people which actually attend the study
Willingness to participate week 48 Proportion of people which actually agreed in relation to the proportion of people which responded to the appeal.
Loss of participants over the study period week 48 Proportion of people who quit during the study
- Secondary Outcome Measures
Name Time Method creatinin week 48 Determination of creatin in the blood
(PMN)-elastase week 48 Determination of (PMN)-elastase in the stool
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.
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.
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.
Coping strategies by COPE week 48 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
lymphocyte (T-cell) profiling week 36 Determination of lymphocyte (T-cell) profiling in the blood
Flourishing by FS-D week 48 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 48 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
alpha-1- antitrypsin week 12 Determination of alpha-antitrypsin in the stool
intestinal microbiome week 36 Determination of intestinal microbiome
Intestinal permeability week 0 confocal laser endomircoscopy
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
professional career (questionnaire) week 0 identification of job qualifications
CRP (C-reactive protein) week 48 Determination of CRP in the blood
Generic quality of life by SF36 week 48 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.
Anxiety and depression by HADS week 48 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 48 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
calprotectin week 48 Determination of calprotectin in the stool
Human beta-defensin-2 (hBD-2) week 48 Determination of hBD-2 in the stool
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)
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)
Adverse events week 48 all adverse events
sex (questionnaire) week 0 identification of the gender (male/female)
School career (questionnaire) week 0 identification of the school career
occupation (questionnaire) week 0 identification of the type of occupation
Disease-specific quality of life by IBD-Q week 48 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)
lactoferrin week 48 Determination of lactoferrin in the stool
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)
alpha-1-antitrypsin week 48 Determination of alpha-antitrypsin in the stool
Disease activity by HBI week 48 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.
BSG (blood cell sedimentation rate) week 48 Determination of BSG in the blood
zonulin week 48 Determination of zonulin in the stool
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)
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)
marital status (questionnaire) week 0 identification of the marital status (married/divorced/single/widowed)
age (questionnaire) week 0 age in years
weight week 0 weight in kilograms
body height week 0 body height in meters
job (questionnaire) week 0 identification of the actual job
Trial Locations
- Locations (1)
Sozialstiftung Bamberg, Klinik für Intergrative Medizin
🇩🇪Bamberg, Bayern, Germany