Randomized Controlled Trial of Stress Reduction and Lifestyle Modification for Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Patients with ulcerative colitis 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. The study will examine the promotion of the quality of life of patients with ulcerative colitis and the positive Influence on stress, psychological symptoms and physiological parameters. 92 patients with ulcerative colitis will be randomized in an Intervention group and a control group for 10 weeks. The primary outcome is the disease-specific quality of life, the secondary outcomes are stress, psychological symptoms, inflammatory parameters, disease activity parameters, bowel parameter and the microbiome.

Official Title
-----------------
Randomized Controlled Trial on the Effect of Stress Reduction and Lifestyle Modification on Disease Activity in Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Behavioral: lifestyle-modification
* Behavioral: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 75 years diagnosis of ulcerative colitis Currently in remission, remission not longer than 12 months limited quality of life or increased subjective stress level Exclusion Criteria: Infectious or chronic active ulcerative colitis Taking glucocorticoids or immunosuppressants within the last 3 months, except stable medication using azathioprine colectomy serious psychological disorder (for example: major depression, addiction, schizophrenia) serious comorbid somatic disease (for example: diabetes mellitus, oncological disease) pregnancy participation in stress reduction program or clinical studies to psychological interventions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lifestyle-modification<br>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<br>* 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 colitis patients.<br>|
| Active Comparator: control group<br>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. | Behavioral: Control group<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-specific quality of life | Inflammatory Bowel Disease Questionnaire (IBD-Q) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-specific quality of life | Inflammatory Bowel Disease Questionnaire (IBD-Q) | 48 weeks | 
| Disease-specific quality of life | Inflammatory Bowel Disease Questionnaire (IBD-Q) | 60 weeks | 
| Disease-specific quality of life | Inflammatory Bowel Disease Questionnaire (IBD-Q) | 108 weeks | 
| Disease activity | Mayo Disease Activity Index (Mayo Score) | 12 weeks | 
| Disease activity | Clinical Activity Index (CAI) | 12 weeks | 
| Disease activity | Mayo Disease Activity Index (Mayo Score) | 48 weeks | 
| Disease activity | Clinical Activity Index (CAI) | 48 weeks | 
| Disease activity | Mayo Disease Activity Index (Mayo Score) | 60 weeks | 
| Disease activity | Clinical Activity Index (CAI) | 60 weeks | 
| Disease activity | Mayo Disease Activity Index (Mayo Score) | 108 weeks | 
| Disease activity | Clinical Activity Index(CAI) | 108 weeks | 
| Endoscopic index | Endoscopic-Index (sigmoidoscopy) | 12 weeks | 
| Endoscopic index | Endoscopic-Index (sigmoidoscopy) | 48 weeks | 
| Endoscopic index | Endoscopic-Index (sigmoidoscopy)) | 60 weeks | 
| Endoscopic index | Endoscopic-Index (sigmoidoscopy) | 108 weeks | 
| Histology | Riley Score | 12 weeks | 
| Histology | Riley Score | 48 weeks | 
| Histology | Riley Score | 60 weeks | 
| Histology | Riley Score | 108 weeks | 
| Generic quality of life | Short Form (SF) -36 (items) health survey | 12 weeks | 
| Generic quality of life | SF-36 health survey | 48 weeks | 
| Generic quality of life | SF-36 health survey | 60 weeks | 
| Generic quality of life | SF-36 health survey | 108 weeks | 
| Anxiety and depression | Hospital Anxiety and Depression Scale (HADS) | 12 weeks | 
| Anxiety and depression | Hospital Anxiety and Depression Scale (HADS) | 48 weeks | 
| Anxiety and depression | Hospital Anxiety and Depression Scale (HADS) | 60 weeks | 
| Anxiety and depression | Hospital Anxiety and Depression Scale (HADS) | 108 weeks | 
| Perceived stress | Perceived Stress Scale (PSS) | 12 weeks | 
| Perceived stress | Perceived Stress Scale (PSS) | 48 weeks | 
| Perceived stress | Perceived Stress Scale (PSS) | 60 weeks | 
| Perceived stress | Perceived Stress Scale (PSS) | 108 weeks | 
| Irritable Bowel Syndrome Symptoms | IBS Severity Scoring System (IBS-SSS) | 12 weeks | 
| Irritable Bowel Syndrome Symptoms | IBS Severity Scoring System (IBS-SSS) | 48 weeks | 
| Irritable Bowel Syndrome Symptoms | IBS Severity Scoring System (IBS-SSS) | 60 weeks | 
| Irritable Bowel Syndrome Symptoms | IBS Severity Scoring System (IBS-SSS) | 108 weeks | 
| Hemogram | leukocyte, hemoglobin, hematocrit, platelet | 12 weeks | 
| Hemogram | leukocyte, hemoglobin, hematocrit, platelet | 48 weeks | 
| Hemogram | leukocyte, hemoglobin, hematocrit, platelet | 60 weeks | 
| Hemogram | leukocyte, hemoglobin, hematocrit, platelet | 108 weeks | 
| Blood sedimentation rate |  | 12 weeks | 
| Blood sedimentation rate |  | 48 weeks | 
| Blood sedimentation rate |  | 60 weeks | 
| Blood sedimentation rate |  | 108 weeks | 
| C-reactive protein |  | 12 weeks | 
| C-reactive protein |  | 48 weeks | 
| C-reactive protein |  | 60 weeks | 
| C-reactive protein |  | 108 weeks | 
| faecal calprotectin |  | 12 weeks | 
| faecal calprotectin |  | 48 weeks | 
| faecal calprotectin |  | 60 weeks | 
| faecal calprotectin |  | 108 weeks | 
| faecal lactoferrin |  | 12 weeks | 
| faecal lactoferrin |  | 48 weeks | 
| faecal lactoferrin |  | 60 weeks | 
| faecal lactoferrin |  | 108 weeks | 
| faecal polymorphonuclear (PMN)-elastase | faecal polymorphonuclear elastase | 12 weeks | 
| faecal PMN-elastase | faecal polymorphonuclear elastase | 48 weeks | 
| faecal PMN-elastase | faecal polymorphonuclear elastase | 60 weeks | 
| faecal PMN-elastase | faecal polymorphonuclear elastase | 108 weeks | 
| faecal human beta-defensin-2 (hBD-2) |  | 12 weeks | 
| faecal hBD-2 | human beta-defensin-2 | 48 weeks | 
| faecal hBD-2 | human beta-defensin-2 | 60 weeks | 
| faecal hBD-2 | human beta-defensin-2 | 108 weeks | 
| Intestinal microbiota | High-throughput 16S ribosomal ribonucleic acid (rRNA) gene sequencing | 12 weeks | 
| Intestinal microbiota | High-throughput 16S rRNA gene sequencing | 48 weeks | 
| Intestinal microbiota | High-throughput 16S rRNA gene sequencing | 60 weeks | 
| Intestinal microbiota | High-throughput 16S rRNA gene sequencing | 108 weeks | 
| Intestinal permeability | LactoseMonitol | 12 weeks | 
| Intestinal permeability | LactoseMonitol | 48 weeks | 
| Intestinal permeability | LactoseMonitol | 60 weeks | 
| Intestinal permeability | LactoseMonitol | 108 weeks | 
| Adverse events |  | 12 weeks | 
| Adverse events |  | 48 weeks | 
| Adverse events |  | 60 weeks | 
| Adverse events |  | 108 weeks |