Crohn DiseaseMBMCrohnNCT05182645
Effect of a Stress Reduction and Lifestyle Modification Programme on the Quality of Life of Crohn's Disease Patients
A study testing lifestyle-modification in people with Crohn Disease, run by Jost Langhorst at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- lifestyle-modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2020to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Sozialstiftung Bamberg, Klinik für Intergrative Medizin
Bamberg, Bavaria, 96049
About this study
Official title: MBMCrohn: Die Wirkung Eines Stressreduktion- Und Lebensstilmodifikations-programms Auf Die Lebensqualität Von Patienten Mit Morbus Crohn- Eine Machbarkeitsstudie
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.
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- lifestyle-modification, waiting control group
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle-modificationBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| lifestyle-modification | Experimental | 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. Receives: Behavioral: lifestyle-modification |
| waiting control group | Active comparator | 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. Receives: Behavioral: waiting control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment success
Proportion of people responding to appeals for studies
Measured: week 48
Willingness to participate
Proportion of people which actually agreed in relation to the proportion of people which responded to the appeal.
Measured: week 48
Attendance
Proportion of people which actually attend the study
Measured: week 48
Loss of participants over the study period
Proportion of people who quit during the study
Measured: week 48
Secondary outcomes (95)
Disease-specific quality of life by IBD-Q
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)
Measured: week 0
Disease-specific quality of life by IBD-Q
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)
Measured: week 12
Disease-specific quality of life by IBD-Q
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)
Measured: week 36
Disease-specific quality of life by IBD-Q
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)
Measured: week 48
Generic quality of life by SF-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.
Measured: week 0
Generic quality of life by SF 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.
Measured: week 12
Generic quality of life by SF36
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.
Measured: week 36
Generic quality of life by SF36
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.
Measured: week 48
Disease activity 2 by BHI
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.
Measured: week 0
Disease activity by HBI
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.
Measured: week 12
Disease activity by HBI
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.
Measured: week 36
Disease activity by HBI
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.
Measured: week 48
Anxiety and depression by HADS
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.
Measured: week 0
Anxiety and depression by HADS
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.
Measured: week 12
Anxiety and depression by HADS
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.
Measured: week 36
Anxiety and depression by HADS
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.
Measured: week 48
Perceived stress by PSS
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
Measured: week 0
Perceived stress by PSS
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
Measured: week 12
Perceived stress by PSS
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
Measured: week 36
Perceived stress by PSS
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
Measured: week 48
Coping strategies by COPE
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
Measured: week 0
Coping strategies by COPE
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
Measured: week 12
Coping strategies by COPE
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
Measured: week 36
Coping strategies by COPE
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
Measured: week 48
Flourishing by FS-D
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.
Measured: week 0
Flourishing by FS-D
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.
Measured: week 12
Flourishing by FS-D
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.
Measured: week 36
Flourishing by FS-D
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.
Measured: week 48
Core Self-Evaluation by CSES
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
Measured: week 0
Core Self-Evaluation by CSES
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
Measured: week 12
Core Self-Evaluation by CSES
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
Measured: week 36
Core Self-Evaluation by CSES
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
Measured: week 48
CRP (C-reactive protein)
Determination of CRP in the blood
Measured: week 0
CRP (C-reactive protein)
Determination of CRP in the blood
Measured: week 12
CRP (C-reactive protein)
Determination of CRP in the blood
Measured: week 36
CRP (C-reactive protein)
Determination of CRP in the blood
Measured: week 48
BSG (blood cell sedimentation rate)
Determination of BSG in the blood
Measured: week 0
BSG (blood cell sedimentation rate)
Determination of BSG in the blood
Measured: week 12
BSG (blood cell sedimentation rate)
Determination of BSG in the blood
Measured: week 36
BSG (blood cell sedimentation rate)
Determination of BSG in the blood
Measured: week 48
creatinin
Determination of creatin in the blood
Measured: week 0
creatinin
Determination of creatin in the blood
Measured: week 12
creatinin
Determination of creatin in the blood
Measured: week 36
creatinin
Determination of creatin in the blood
Measured: week 48
lymphocyte (T-cell) profiling
Determination of lymphocyte (T-cell) profiling in the blood
Measured: week 0
lymphocyte (T-cell) profiling
Determination of lymphocyte (T-cell) profiling in the blood
Measured: week 12
lymphocyte (T-cell) profiling
Determination of lymphocyte (T-cell) profiling in the blood
Measured: week 36
calprotectin
Determination of calprotectin in the stool
Measured: week 0
calprotectin
Determination of calprotectin in the stool
Measured: week 12
calprotectin
Determination of calprotectin in the stool
Measured: week 36
calprotectin
Determination of calprotectin in the stool
Measured: week 48
lactoferrin
Determination of lactoferrin in the stool
Measured: week 0
lactoferrin
Determination of lactoferrin in the stool
Measured: week 12
lactoferrin
Determination of lactoferrin in the stool
Measured: week 36
lactoferrin
Determination of lactoferrin in the stool
Measured: week 48
(PMN)-elastase
Determination of (PMN)-elastase in the stool
Measured: week 0
(PMN)-elastase
Determination of (PMN)-elastase in the stool
Measured: week 12
(PMN)-elastase
Determination of (PMN)-elastase in the stool
Measured: week 36
(PMN)-elastase
Determination of (PMN)-elastase in the stool
Measured: week 48
Human beta-defensin-2 (hBD-2)
Determination of hBD-2 in the stool
Measured: week 0
Human beta-defensin-2 (hBD-2)
Determination of hBD-2 in the stool
Measured: week 12
Human beta-defensin-2 (hBD-2)
Determination of hBD-2 in the stool
Measured: week 36
Human beta-defensin-2 (hBD-2)
Determination of hBD-2 in the stool
Measured: week 48
zonulin
Determination of zonulin in the stool
Measured: week 0
zonulin
Determination of zonulin in the stool
Measured: week 12
zonulin
Determination of zonulin in the stool
Measured: week 36
zonulin
Determination of zonulin in the stool
Measured: week 48
alpha-1-antitrypsin
Determination of alpha-antitrypsin in the stool
Measured: week 0
alpha-1- antitrypsin
Determination of alpha-antitrypsin in the stool
Measured: week 12
alpha-1-antitrypsin
Determination of alpha-antitrypsin in the stool
Measured: week 36
alpha-1-antitrypsin
Determination of alpha-antitrypsin in the stool
Measured: week 48
intestinal microbiome
Determination of intestinal microbiome
Measured: week 0
intestinal microbiome
Determination of intestinal microbiome
Measured: week 36
Intestinal permeability
confocal laser endomircoscopy
Measured: week 0
cortisol
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)
Measured: week 12
ACTH
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)
Measured: week 12
prolactin levels
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)
Measured: week 12
glucocorticoid and β-adrenergic regulation of IL-8 and IL-10
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)
Measured: week 12
TNF-α production by peripheral blood cells
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)
Measured: week 12
heart rate
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)
Measured: week 12
blood pressure systolic and diastolic
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)
Measured: week 12
STAI-S
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)
Measured: week 12
Adverse events
all adverse events
Measured: week 12
Adverse events
all adverse events
Measured: week 36
Adverse events
all adverse events
Measured: week 48
qualitatives Interview
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
Measured: week 36
age (questionnaire)
age in years
Measured: week 0
sex (questionnaire)
identification of the gender (male/female)
Measured: week 0
weight
weight in kilograms
Measured: week 0
body height
body height in meters
Measured: week 0
School career (questionnaire)
identification of the school career
Measured: week 0
job (questionnaire)
identification of the actual job
Measured: week 0
professional career (questionnaire)
identification of job qualifications
Measured: week 0
marital status (questionnaire)
identification of the marital status (married/divorced/single/widowed)
Measured: week 0
occupation (questionnaire)
identification of the type of occupation
Measured: week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Jul 2020
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Waiting Control Group Design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jost Langhorst
- Sponsor type
- University, hospital or other
- Collaborators
- Sozialstiftung Bamberg, University of Wuerzburg, Wuerzburg University Hospital, Bavarian State Ministry of Health and Care
- Responsible party
- Sponsor-investigator, Jost Langhorst, Universität Duisburg-Essen
- Investigators
- Jost Langhorst, Prof., Study director, Sozialstiftung Bamberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182645
- Sponsor's protocol ID
- 19096
- Acronym
- MBMCrohn
- Status last verified
- Nov 2022
- First submitted
- 11 Aug 2020
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391Schlee C, Uecker C, Oznur O, Bauer N, Langhorst J. Participants' perspectives on a multimodal stress management and comprehensive lifestyle modification program for patients with Crohn's disease-A qualitative interview study. PLoS One. 2024 Nov 13;19(11):e0313127. doi: 10.1371/journal.pone.0313127. eCollection 2024.
PubMed 39536026Mekes-Adamczyk A, Gausmann N, Oznur O, Pfuhlmann K, Dziobaka J, Buer J, Langhorst J, Westendorf AM. Lifestyle Intervention Modulates the CD4+ T Cell Profile in the Blood of Crohn's Disease Patients. Inflamm Bowel Dis. 2025 Jan 6;31(1):200-209. doi: 10.1093/ibd/izae154.
PubMed 39102712Bauer 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.
PubMed 36081609
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MBMCrohn: Die Wirkung Eines Stressreduktion- Und Lebensstilmodifikations-programms Auf Die Lebensqualität Von Patienten Mit Morbus Crohn- Eine Machbarkeitsstudie
- ClinicalTrials.gov ID
- NCT05182645
- Acronym / sponsor ID
- MBMCrohn / 19096
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Jost LanghorstUniversity, hospital or other
- Collaborators
- Sozialstiftung Bamberg, University of Wuerzburg, Wuerzburg University Hospital, Bavarian State Ministry of Health and Care
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Waiting Control Group Design
| Arm | Type | Receives |
|---|---|---|
| lifestyle-modification | Experimental | Behavioral: lifestyle-modificationOnce 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 | Active comparator | Behavioral: waiting control groupA 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyle-modificationThe 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. | Behavioural | lifestyle-modification |
| waiting control groupParticipants 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. | Behavioural | waiting control group |
Primary outcome
Recruitment success
Time frame: week 48
Proportion of people responding to appeals for studies
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.
Attendance
Time frame: week 48
Proportion of people which actually attend the study
Loss of participants over the study period
Time frame: week 48
Proportion of people who quit during the study
95 secondary outcomes
Disease-specific quality of life by IBD-Q
Time frame: week 0
Disease-specific quality of life by IBD-Q
Time frame: week 12
Disease-specific quality of life by IBD-Q
Time frame: week 36
Disease-specific quality of life by IBD-Q
Time frame: week 48
Generic quality of life by SF-36
Time frame: week 0
Generic quality of life by SF 36
Time frame: week 12
Generic quality of life by SF36
Time frame: week 36
Generic quality of life by SF36
Time frame: week 48
Disease activity 2 by BHI
Time frame: week 0
Disease activity by HBI
Time frame: week 12
Disease activity by HBI
Time frame: week 36
Disease activity by HBI
Time frame: week 48
Anxiety and depression by HADS
Time frame: week 0
Anxiety and depression by HADS
Time frame: week 12
Anxiety and depression by HADS
Time frame: week 36
Anxiety and depression by HADS
Time frame: week 48
Perceived stress by PSS
Time frame: week 0
Perceived stress by PSS
Time frame: week 12
Perceived stress by PSS
Time frame: week 36
Perceived stress by PSS
Time frame: week 48
Coping strategies by COPE
Time frame: week 0
Coping strategies by COPE
Time frame: week 12
Coping strategies by COPE
Time frame: week 36
Coping strategies by COPE
Time frame: week 48
Flourishing by FS-D
Time frame: week 0
Flourishing by FS-D
Time frame: week 12
Flourishing by FS-D
Time frame: week 36
Flourishing by FS-D
Time frame: week 48
Core Self-Evaluation by CSES
Time frame: week 0
Core Self-Evaluation by CSES
Time frame: week 12
Core Self-Evaluation by CSES
Time frame: week 36
Core Self-Evaluation by CSES
Time frame: week 48
CRP (C-reactive protein)
Time frame: week 0
CRP (C-reactive protein)
Time frame: week 12
CRP (C-reactive protein)
Time frame: week 36
CRP (C-reactive protein)
Time frame: week 48
BSG (blood cell sedimentation rate)
Time frame: week 0
BSG (blood cell sedimentation rate)
Time frame: week 12
BSG (blood cell sedimentation rate)
Time frame: week 36
BSG (blood cell sedimentation rate)
Time frame: week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
- Derived from this study: PubMed 39536026Schlee C, Uecker C, Oznur O, Bauer N, Langhorst J. Participants' perspectives on a multimodal stress management and comprehensive lifestyle modification program for patients with Crohn's disease-A qualitative interview study. PLoS One. 2024 Nov 13;19(11):e0313127. doi: 10.1371/journal.pone.0313127. eCollection 2024.
- Derived from this study: PubMed 39102712Mekes-Adamczyk A, Gausmann N, Oznur O, Pfuhlmann K, Dziobaka J, Buer J, Langhorst J, Westendorf AM. Lifestyle Intervention Modulates the CD4+ T Cell Profile in the Blood of Crohn's Disease Patients. Inflamm Bowel Dis. 2025 Jan 6;31(1):200-209. doi: 10.1093/ibd/izae154.
- Derived from this study: PubMed 36081609Bauer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jost Langhorst, Prof. study director
Sozialstiftung Bamberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle-modification in people with Crohn Disease, run by Jost Langhorst at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment success (time frame: week 48). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05182645, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.