Skip to main content
OpenTrials
Completed

NCT Number: NCT05182645

Effect of a Stress Reduction and Lifestyle Modification Programme on the Quality of Life of Crohn's Disease Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sozialstiftung Bamberg, Klinik für Intergrative Medizin

Bamberg, Bavaria, 96049, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lifestyle-modification

Behavioral

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.

waiting control group

Behavioral

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 outcomes

  1. Recruitment success

    Time frame: week 48

    Proportion of people responding to appeals for studies

  2. Willingness to participate

    Time frame: week 48

    Proportion of people which actually agreed in relation to the proportion of people which responded to the appeal.

  3. Attendance

    Time frame: week 48

    Proportion of people which actually attend the study

  4. Loss of participants over the study period

    Time frame: week 48

    Proportion of people who quit during the study

Secondary outcomes

  1. Disease-specific quality of life by IBD-Q

    Time frame: 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)

  2. Disease-specific quality of life by IBD-Q

    Time frame: week 12

    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)

  3. Disease-specific quality of life by IBD-Q

    Time frame: week 36

    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)

  4. Disease-specific quality of life by IBD-Q

    Time frame: 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)

  5. Generic quality of life by SF-36

    Time frame: 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.

  6. Generic quality of life by SF 36

    Time frame: 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.

  7. Generic quality of life by SF36

    Time frame: 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.

  8. Generic quality of life by SF36

    Time frame: 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.

  9. Disease activity 2 by BHI

    Time frame: 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.

  10. Disease activity by HBI

    Time frame: 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.

  11. Disease activity by HBI

    Time frame: week 36

    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.

  12. Disease activity by HBI

    Time frame: 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.

  13. Anxiety and depression by HADS

    Time frame: 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.

  14. Anxiety and depression by HADS

    Time frame: week 12

    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.

  15. Anxiety and depression by HADS

    Time frame: week 36

    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.

  16. Anxiety and depression by HADS

    Time frame: 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.

  17. Perceived stress by PSS

    Time frame: 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

  18. Perceived stress by PSS

    Time frame: week 12

    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

  19. Perceived stress by PSS

    Time frame: week 36

    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

  20. Perceived stress by PSS

    Time frame: 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

  21. Coping strategies by COPE

    Time frame: 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

  22. Coping strategies by COPE

    Time frame: week 12

    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

  23. Coping strategies by COPE

    Time frame: week 36

    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

  24. Coping strategies by COPE

    Time frame: 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

  25. Flourishing by FS-D

    Time frame: 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.

  26. Flourishing by FS-D

    Time frame: week 12

    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.

  27. Flourishing by FS-D

    Time frame: week 36

    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.

  28. Flourishing by FS-D

    Time frame: 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.

  29. Core Self-Evaluation by CSES

    Time frame: 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

  30. Core Self-Evaluation by CSES

    Time frame: week 12

    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

  31. Core Self-Evaluation by CSES

    Time frame: week 36

    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

  32. Core Self-Evaluation by CSES

    Time frame: 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

  33. CRP (C-reactive protein)

    Time frame: week 0

    Determination of CRP in the blood

  34. CRP (C-reactive protein)

    Time frame: week 12

    Determination of CRP in the blood

  35. CRP (C-reactive protein)

    Time frame: week 36

    Determination of CRP in the blood

  36. CRP (C-reactive protein)

    Time frame: week 48

    Determination of CRP in the blood

  37. BSG (blood cell sedimentation rate)

    Time frame: week 0

    Determination of BSG in the blood

  38. BSG (blood cell sedimentation rate)

    Time frame: week 12

    Determination of BSG in the blood

  39. BSG (blood cell sedimentation rate)

    Time frame: week 36

    Determination of BSG in the blood

  40. BSG (blood cell sedimentation rate)

    Time frame: week 48

    Determination of BSG in the blood

  41. creatinin

    Time frame: week 0

    Determination of creatin in the blood

  42. creatinin

    Time frame: week 12

    Determination of creatin in the blood

  43. creatinin

    Time frame: week 36

    Determination of creatin in the blood

  44. creatinin

    Time frame: week 48

    Determination of creatin in the blood

  45. lymphocyte (T-cell) profiling

    Time frame: week 0

    Determination of lymphocyte (T-cell) profiling in the blood

  46. lymphocyte (T-cell) profiling

    Time frame: week 12

    Determination of lymphocyte (T-cell) profiling in the blood

  47. lymphocyte (T-cell) profiling

    Time frame: week 36

    Determination of lymphocyte (T-cell) profiling in the blood

  48. calprotectin

    Time frame: week 0

    Determination of calprotectin in the stool

  49. calprotectin

    Time frame: week 12

    Determination of calprotectin in the stool

  50. calprotectin

    Time frame: week 36

    Determination of calprotectin in the stool

  51. calprotectin

    Time frame: week 48

    Determination of calprotectin in the stool

  52. lactoferrin

    Time frame: week 0

    Determination of lactoferrin in the stool

  53. lactoferrin

    Time frame: week 12

    Determination of lactoferrin in the stool

  54. lactoferrin

    Time frame: week 36

    Determination of lactoferrin in the stool

  55. lactoferrin

    Time frame: week 48

    Determination of lactoferrin in the stool

  56. (PMN)-elastase

    Time frame: week 0

    Determination of (PMN)-elastase in the stool

  57. (PMN)-elastase

    Time frame: week 12

    Determination of (PMN)-elastase in the stool

  58. (PMN)-elastase

    Time frame: week 36

    Determination of (PMN)-elastase in the stool

  59. (PMN)-elastase

    Time frame: week 48

    Determination of (PMN)-elastase in the stool

  60. Human beta-defensin-2 (hBD-2)

    Time frame: week 0

    Determination of hBD-2 in the stool

  61. Human beta-defensin-2 (hBD-2)

    Time frame: week 12

    Determination of hBD-2 in the stool

  62. Human beta-defensin-2 (hBD-2)

    Time frame: week 36

    Determination of hBD-2 in the stool

  63. Human beta-defensin-2 (hBD-2)

    Time frame: week 48

    Determination of hBD-2 in the stool

  64. zonulin

    Time frame: week 0

    Determination of zonulin in the stool

  65. zonulin

    Time frame: week 12

    Determination of zonulin in the stool

  66. zonulin

    Time frame: week 36

    Determination of zonulin in the stool

  67. zonulin

    Time frame: week 48

    Determination of zonulin in the stool

  68. alpha-1-antitrypsin

    Time frame: week 0

    Determination of alpha-antitrypsin in the stool

  69. alpha-1- antitrypsin

    Time frame: week 12

    Determination of alpha-antitrypsin in the stool

  70. alpha-1-antitrypsin

    Time frame: week 36

    Determination of alpha-antitrypsin in the stool

  71. alpha-1-antitrypsin

    Time frame: week 48

    Determination of alpha-antitrypsin in the stool

  72. intestinal microbiome

    Time frame: week 0

    Determination of intestinal microbiome

  73. intestinal microbiome

    Time frame: week 36

    Determination of intestinal microbiome

  74. Intestinal permeability

    Time frame: week 0

    confocal laser endomircoscopy

  75. cortisol

    Time frame: 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)

  76. ACTH

    Time frame: 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)

  77. prolactin levels

    Time frame: 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)

  78. glucocorticoid and β-adrenergic regulation of IL-8 and IL-10

    Time frame: 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)

  79. TNF-α production by peripheral blood cells

    Time frame: 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)

  80. heart rate

    Time frame: 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)

  81. blood pressure systolic and diastolic

    Time frame: 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)

  82. STAI-S

    Time frame: 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)

  83. Adverse events

    Time frame: week 12

    all adverse events

  84. Adverse events

    Time frame: week 36

    all adverse events

  85. Adverse events

    Time frame: week 48

    all adverse events

  86. qualitatives Interview

    Time frame: 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

  87. age (questionnaire)

    Time frame: week 0

    age in years

  88. sex (questionnaire)

    Time frame: week 0

    identification of the gender (male/female)

  89. weight

    Time frame: week 0

    weight in kilograms

  90. body height

    Time frame: week 0

    body height in meters

  91. School career (questionnaire)

    Time frame: week 0

    identification of the school career

  92. job (questionnaire)

    Time frame: week 0

    identification of the actual job

  93. professional career (questionnaire)

    Time frame: week 0

    identification of job qualifications

  94. marital status (questionnaire)

    Time frame: week 0

    identification of the marital status (married/divorced/single/widowed)

  95. occupation (questionnaire)

    Time frame: week 0

    identification of the type of occupation

Sponsors and collaborators

Lead sponsor

Jost Langhorst

Other

Collaborators

  • Bavarian State Ministry of Health and Care
  • Sozialstiftung Bamberg
  • University of Wuerzburg
  • Wuerzburg University Hospital

Registry information

Official study title

MBMCrohn: Die Wirkung Eines Stressreduktion- Und Lebensstilmodifikations-programms Auf Die Lebensqualität Von Patienten Mit Morbus Crohn- Eine Machbarkeitsstudie

Acronym: MBMCrohn

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 10, 2022
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.