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

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ClinicalTrials.gov Identifier: NCT02721823
Recruitment Status : Unknown
Verified May 2017 by Jost Langhorst, Universität Duisburg-Essen.
Recruitment status was:  Recruiting
First Posted : March 29, 2016
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Jost Langhorst, Universität Duisburg-Essen

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Behavioral: lifestyle-modification Behavioral: Control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial on the Effect of Stress Reduction and Lifestyle Modification on Disease Activity in Ulcerative Colitis
Study Start Date : March 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: lifestyle-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 colitis patients.

Active Comparator: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Disease-specific quality of life [ Time Frame: 12 weeks ]
    Inflammatory Bowel Disease Questionnaire (IBD-Q)


Secondary Outcome Measures :
  1. Disease-specific quality of life [ Time Frame: 48 weeks ]
    Inflammatory Bowel Disease Questionnaire (IBD-Q)

  2. Disease-specific quality of life [ Time Frame: 60 weeks ]
    Inflammatory Bowel Disease Questionnaire (IBD-Q)

  3. Disease-specific quality of life [ Time Frame: 108 weeks ]
    Inflammatory Bowel Disease Questionnaire (IBD-Q)

  4. Disease activity [ Time Frame: 12 weeks ]
    Mayo Disease Activity Index (Mayo Score)

  5. Disease activity [ Time Frame: 12 weeks ]
    Clinical Activity Index (CAI)

  6. Disease activity [ Time Frame: 48 weeks ]
    Mayo Disease Activity Index (Mayo Score)

  7. Disease activity [ Time Frame: 48 weeks ]
    Clinical Activity Index (CAI)

  8. Disease activity [ Time Frame: 60 weeks ]
    Mayo Disease Activity Index (Mayo Score)

  9. Disease activity [ Time Frame: 60 weeks ]
    Clinical Activity Index (CAI)

  10. Disease activity [ Time Frame: 108 weeks ]
    Mayo Disease Activity Index (Mayo Score)

  11. Disease activity [ Time Frame: 108 weeks ]
    Clinical Activity Index(CAI)

  12. Endoscopic index [ Time Frame: 12 weeks ]
    Endoscopic-Index (sigmoidoscopy)

  13. Endoscopic index [ Time Frame: 48 weeks ]
    Endoscopic-Index (sigmoidoscopy)

  14. Endoscopic index [ Time Frame: 60 weeks ]
    Endoscopic-Index (sigmoidoscopy))

  15. Endoscopic index [ Time Frame: 108 weeks ]
    Endoscopic-Index (sigmoidoscopy)

  16. Histology [ Time Frame: 12 weeks ]
    Riley Score

  17. Histology [ Time Frame: 48 weeks ]
    Riley Score

  18. Histology [ Time Frame: 60 weeks ]
    Riley Score

  19. Histology [ Time Frame: 108 weeks ]
    Riley Score

  20. Generic quality of life [ Time Frame: 12 weeks ]
    Short Form (SF) -36 (items) health survey

  21. Generic quality of life [ Time Frame: 48 weeks ]
    SF-36 health survey

  22. Generic quality of life [ Time Frame: 60 weeks ]
    SF-36 health survey

  23. Generic quality of life [ Time Frame: 108 weeks ]
    SF-36 health survey

  24. Anxiety and depression [ Time Frame: 12 weeks ]
    Hospital Anxiety and Depression Scale (HADS)

  25. Anxiety and depression [ Time Frame: 48 weeks ]
    Hospital Anxiety and Depression Scale (HADS)

  26. Anxiety and depression [ Time Frame: 60 weeks ]
    Hospital Anxiety and Depression Scale (HADS)

  27. Anxiety and depression [ Time Frame: 108 weeks ]
    Hospital Anxiety and Depression Scale (HADS)

  28. Perceived stress [ Time Frame: 12 weeks ]
    Perceived Stress Scale (PSS)

  29. Perceived stress [ Time Frame: 48 weeks ]
    Perceived Stress Scale (PSS)

  30. Perceived stress [ Time Frame: 60 weeks ]
    Perceived Stress Scale (PSS)

  31. Perceived stress [ Time Frame: 108 weeks ]
    Perceived Stress Scale (PSS)

  32. Irritable Bowel Syndrome Symptoms [ Time Frame: 12 weeks ]
    IBS Severity Scoring System (IBS-SSS)

  33. Irritable Bowel Syndrome Symptoms [ Time Frame: 48 weeks ]
    IBS Severity Scoring System (IBS-SSS)

  34. Irritable Bowel Syndrome Symptoms [ Time Frame: 60 weeks ]
    IBS Severity Scoring System (IBS-SSS)

  35. Irritable Bowel Syndrome Symptoms [ Time Frame: 108 weeks ]
    IBS Severity Scoring System (IBS-SSS)

  36. Hemogram [ Time Frame: 12 weeks ]
    leukocyte, hemoglobin, hematocrit, platelet

  37. Hemogram [ Time Frame: 48 weeks ]
    leukocyte, hemoglobin, hematocrit, platelet

  38. Hemogram [ Time Frame: 60 weeks ]
    leukocyte, hemoglobin, hematocrit, platelet

  39. Hemogram [ Time Frame: 108 weeks ]
    leukocyte, hemoglobin, hematocrit, platelet

  40. Blood sedimentation rate [ Time Frame: 12 weeks ]
  41. Blood sedimentation rate [ Time Frame: 48 weeks ]
  42. Blood sedimentation rate [ Time Frame: 60 weeks ]
  43. Blood sedimentation rate [ Time Frame: 108 weeks ]
  44. C-reactive protein [ Time Frame: 12 weeks ]
  45. C-reactive protein [ Time Frame: 48 weeks ]
  46. C-reactive protein [ Time Frame: 60 weeks ]
  47. C-reactive protein [ Time Frame: 108 weeks ]
  48. faecal calprotectin [ Time Frame: 12 weeks ]
  49. faecal calprotectin [ Time Frame: 48 weeks ]
  50. faecal calprotectin [ Time Frame: 60 weeks ]
  51. faecal calprotectin [ Time Frame: 108 weeks ]
  52. faecal lactoferrin [ Time Frame: 12 weeks ]
  53. faecal lactoferrin [ Time Frame: 48 weeks ]
  54. faecal lactoferrin [ Time Frame: 60 weeks ]
  55. faecal lactoferrin [ Time Frame: 108 weeks ]
  56. faecal polymorphonuclear (PMN)-elastase [ Time Frame: 12 weeks ]
    faecal polymorphonuclear elastase

  57. faecal PMN-elastase [ Time Frame: 48 weeks ]
    faecal polymorphonuclear elastase

  58. faecal PMN-elastase [ Time Frame: 60 weeks ]
    faecal polymorphonuclear elastase

  59. faecal PMN-elastase [ Time Frame: 108 weeks ]
    faecal polymorphonuclear elastase

  60. faecal human beta-defensin-2 (hBD-2) [ Time Frame: 12 weeks ]
  61. faecal hBD-2 [ Time Frame: 48 weeks ]
    human beta-defensin-2

  62. faecal hBD-2 [ Time Frame: 60 weeks ]
    human beta-defensin-2

  63. faecal hBD-2 [ Time Frame: 108 weeks ]
    human beta-defensin-2

  64. Intestinal microbiota [ Time Frame: 12 weeks ]
    High-throughput 16S ribosomal ribonucleic acid (rRNA) gene sequencing

  65. Intestinal microbiota [ Time Frame: 48 weeks ]
    High-throughput 16S rRNA gene sequencing

  66. Intestinal microbiota [ Time Frame: 60 weeks ]
    High-throughput 16S rRNA gene sequencing

  67. Intestinal microbiota [ Time Frame: 108 weeks ]
    High-throughput 16S rRNA gene sequencing

  68. Intestinal permeability [ Time Frame: 12 weeks ]
    LactoseMonitol

  69. Intestinal permeability [ Time Frame: 48 weeks ]
    LactoseMonitol

  70. Intestinal permeability [ Time Frame: 60 weeks ]
    LactoseMonitol

  71. Intestinal permeability [ Time Frame: 108 weeks ]
    LactoseMonitol

  72. Adverse events [ Time Frame: 12 weeks ]
  73. Adverse events [ Time Frame: 48 weeks ]
  74. Adverse events [ Time Frame: 60 weeks ]
  75. Adverse events [ Time Frame: 108 weeks ]


Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721823


Contacts
Layout table for location contacts
Contact: Jost Langhorst, Prof. Dr. med. 020117425012 j.langhorst@kliniken-essen-mitte.de

Locations
Layout table for location information
Germany
Kliniken Essen-Mitte, Knappschafts Krankenhaus Recruiting
Essen, NRW, Germany, 45276
Contact: Jost Langhorst, Prof. Dr.    49-201-174 25012    j.langhorst@kliniken-essen-mitte.de   
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
Layout table for investigator information
Principal Investigator: Jost Langhorst, Prof. Dr. med. Kliniken Essen-Mitte
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jost Langhorst, Medical vice director, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT02721823    
Other Study ID Numbers: 15-6554-BO
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases