Clinical trial NCT05182645: Effect of a Stress Reduction and Lifestyle Modification Programme on the Quality of Life of Crohn's Disease Patients
Official title: MBMCrohn: Die Wirkung Eines Stressreduktion- Und Lebensstilmodifikations-programms Auf Die Lebensqualität Von Patienten Mit Morbus Crohn- Eine Machbarkeitsstudie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: Sozialstiftung Bamberg
name: University of Wuerzburg
name: Wuerzburg University Hospital
name: Bavarian State Ministry of Health and Care
First posted: 2022-01-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Waiting Control Group Design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment success
timeFrame: week 48
measure: Willingness to participate
timeFrame: week 48
measure: Attendance
timeFrame: week 48
measure: Loss of participants over the study period
timeFrame: week 48
Secondary outcomes:
measure: Disease-specific quality of life by IBD-Q
timeFrame: week 0
measure: Disease-specific quality of life by IBD-Q
timeFrame: week 12
measure: Disease-specific quality of life by IBD-Q
timeFrame: week 36
measure: Disease-specific quality of life by IBD-Q
timeFrame: week 48
measure: Generic quality of life by SF-36
timeFrame: week 0
measure: Generic quality of life by SF 36
timeFrame: week 12
measure: Generic quality of life by SF36
timeFrame: week 36
measure: Generic quality of life by SF36
timeFrame: week 48
measure: Disease activity 2 by BHI
timeFrame: week 0
measure: Disease activity by HBI
timeFrame: week 12
measure: Disease activity by HBI
timeFrame: week 36
measure: Disease activity by HBI
timeFrame: week 48
measure: Anxiety and depression by HADS
timeFrame: week 0
measure: Anxiety and depression by HADS
timeFrame: week 12
measure: Anxiety and depression by HADS
timeFrame: week 36
measure: Anxiety and depression by HADS
timeFrame: week 48
measure: Perceived stress by PSS
timeFrame: week 0
measure: Perceived stress by PSS
timeFrame: week 12
measure: Perceived stress by PSS
timeFrame: week 36
measure: Perceived stress by PSS
timeFrame: week 48
measure: Coping strategies by COPE
timeFrame: week 0
measure: Coping strategies by COPE
timeFrame: week 12
measure: Coping strategies by COPE
timeFrame: week 36
measure: Coping strategies by COPE
timeFrame: week 48
measure: Flourishing by FS-D
timeFrame: week 0
measure: Flourishing by FS-D
timeFrame: week 12
measure: Flourishing by FS-D
timeFrame: week 36
measure: Flourishing by FS-D
timeFrame: week 48
measure: Core Self-Evaluation by CSES
timeFrame: week 0
measure: Core Self-Evaluation by CSES
timeFrame: week 12
measure: Core Self-Evaluation by CSES
timeFrame: week 36
measure: Core Self-Evaluation by CSES
timeFrame: week 48
measure: CRP (C-reactive protein)
timeFrame: week 0
measure: CRP (C-reactive protein)
timeFrame: week 12
measure: CRP (C-reactive protein)
timeFrame: week 36
measure: CRP (C-reactive protein)
timeFrame: week 48
measure: BSG (blood cell sedimentation rate)
timeFrame: week 0
measure: BSG (blood cell sedimentation rate)
timeFrame: week 12
measure: BSG (blood cell sedimentation rate)
timeFrame: week 36
measure: BSG (blood cell sedimentation rate)
timeFrame: week 48
measure: creatinin
timeFrame: week 0
measure: creatinin
timeFrame: week 12
measure: creatinin
timeFrame: week 36
measure: creatinin
timeFrame: week 48
measure: lymphocyte (T-cell) profiling
timeFrame: week 0
measure: lymphocyte (T-cell) profiling
timeFrame: week 12
measure: lymphocyte (T-cell) profiling
timeFrame: week 36
measure: calprotectin
timeFrame: week 0
measure: calprotectin
timeFrame: week 12
measure: calprotectin
timeFrame: week 36
measure: calprotectin
timeFrame: week 48
measure: lactoferrin
timeFrame: week 0
measure: lactoferrin
timeFrame: week 12
measure: lactoferrin
timeFrame: week 36
measure: lactoferrin
timeFrame: week 48
measure: (PMN)-elastase
timeFrame: week 0
measure: (PMN)-elastase
timeFrame: week 12
measure: (PMN)-elastase
timeFrame: week 36
measure: (PMN)-elastase
timeFrame: week 48
measure: Human beta-defensin-2 (hBD-2)
timeFrame: week 0
measure: Human beta-defensin-2 (hBD-2)
timeFrame: week 12
measure: Human beta-defensin-2 (hBD-2)
timeFrame: week 36
measure: Human beta-defensin-2 (hBD-2)
timeFrame: week 48
measure: zonulin
timeFrame: week 0
measure: zonulin
timeFrame: week 12
measure: zonulin
timeFrame: week 36
measure: zonulin
timeFrame: week 48
measure: alpha-1-antitrypsin
timeFrame: week 0
measure: alpha-1- antitrypsin
timeFrame: week 12
measure: alpha-1-antitrypsin
timeFrame: week 36
measure: alpha-1-antitrypsin
timeFrame: week 48
measure: intestinal microbiome
timeFrame: week 0
measure: intestinal microbiome
timeFrame: week 36
measure: Intestinal permeability
timeFrame: week 0
measure: cortisol
timeFrame: week 12
measure: ACTH
timeFrame: week 12
measure: prolactin levels
timeFrame: week 12
measure: glucocorticoid and β-adrenergic regulation of IL-8 and IL-10
timeFrame: week 12
measure: TNF-α production by peripheral blood cells
timeFrame: week 12
measure: heart rate
timeFrame: week 12
measure: blood pressure systolic and diastolic
timeFrame: week 12
measure: STAI-S
timeFrame: week 12
measure: Adverse events
timeFrame: week 12
measure: Adverse events
timeFrame: week 36
measure: Adverse events
timeFrame: week 48
measure: qualitatives Interview
timeFrame: week 36
measure: age (questionnaire)
timeFrame: week 0
measure: sex (questionnaire)
timeFrame: week 0
measure: weight
timeFrame: week 0
measure: body height
timeFrame: week 0
measure: School career (questionnaire)
timeFrame: week 0
measure: job (questionnaire)
timeFrame: week 0
measure: professional career (questionnaire)
timeFrame: week 0
measure: marital status (questionnaire)
timeFrame: week 0
measure: occupation (questionnaire)
timeFrame: week 0
Other outcomes:
Locations:
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg, Klinik für Intergrative Medizin
state: Bayern
Study officials:
affiliation: Sozialstiftung Bamberg
name: Jost Langhorst, Prof.
role: STUDY_DIRECTOR
References:
citation: Bauer N, Loffler C, Oznur O, Uecker C, Keil T, Langhorst J. Mind-body-medicine and comprehensive lifestyle-modification in patients with Crohn's disease-Feasibility of a randomized controlled trial under pandemic circumstances. Front Integr Neurosci. 2022 Aug 23;16:960301. doi: 10.3389/fnint.2022.960301. eCollection 2022.