AzTrials
AzTrials

Ulcerative ColitisMBMColNCT02721823

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

A study testing lifestyle-modification in people with Ulcerative Colitis, run by Universität Duisburg-Essen at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
lifestyle-modification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteGermany
Study dates
Mar 2016to Oct 2019
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

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Jost Langhorst, Prof. Dr. med. contact

020117425012

j.langhorst@kliniken-essen-mitte.de

Germany1 site, 1 recruiting

  • Kliniken Essen-Mitte, Knappschafts Krankenhaus

    Essen, North Rhine-Westphalia, 45276

    Jost Langhorst, Prof. Dr., 49-201-174 25012, j.langhorst@kliniken-essen-mitte.de

    Recruiting

Other trials in Germany

About this study

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

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.

Being tested
lifestyle-modification, Control group
Medical subject headings
Colitis, Ulcerative

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 colitis patients.

  • 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 groups in NCT02721823
Study groupRoleWhat they receive
lifestyle-modificationExperimentalOnce 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
control groupActive comparatorA 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.
Receives: Behavioral: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-specific quality of life

    Inflammatory Bowel Disease Questionnaire (IBD-Q)

    Measured: 12 weeks

Secondary outcomes (75)

  1. Disease-specific quality of life

    Inflammatory Bowel Disease Questionnaire (IBD-Q)

    Measured: 48 weeks

  2. Disease-specific quality of life

    Inflammatory Bowel Disease Questionnaire (IBD-Q)

    Measured: 60 weeks

  3. Disease-specific quality of life

    Inflammatory Bowel Disease Questionnaire (IBD-Q)

    Measured: 108 weeks

  4. Disease activity

    Mayo Disease Activity Index (Mayo Score)

    Measured: 12 weeks

  5. Disease activity

    Clinical Activity Index (CAI)

    Measured: 12 weeks

  6. Disease activity

    Mayo Disease Activity Index (Mayo Score)

    Measured: 48 weeks

  7. Disease activity

    Clinical Activity Index (CAI)

    Measured: 48 weeks

  8. Disease activity

    Mayo Disease Activity Index (Mayo Score)

    Measured: 60 weeks

  9. Disease activity

    Clinical Activity Index (CAI)

    Measured: 60 weeks

  10. Disease activity

    Mayo Disease Activity Index (Mayo Score)

    Measured: 108 weeks

  11. Disease activity

    Clinical Activity Index(CAI)

    Measured: 108 weeks

  12. Endoscopic index

    Endoscopic-Index (sigmoidoscopy)

    Measured: 12 weeks

  13. Endoscopic index

    Endoscopic-Index (sigmoidoscopy)

    Measured: 48 weeks

  14. Endoscopic index

    Endoscopic-Index (sigmoidoscopy))

    Measured: 60 weeks

  15. Endoscopic index

    Endoscopic-Index (sigmoidoscopy)

    Measured: 108 weeks

  16. Histology

    Riley Score

    Measured: 12 weeks

  17. Histology

    Riley Score

    Measured: 48 weeks

  18. Histology

    Riley Score

    Measured: 60 weeks

  19. Histology

    Riley Score

    Measured: 108 weeks

  20. Generic quality of life

    Short Form (SF) -36 (items) health survey

    Measured: 12 weeks

  21. Generic quality of life

    SF-36 health survey

    Measured: 48 weeks

  22. Generic quality of life

    SF-36 health survey

    Measured: 60 weeks

  23. Generic quality of life

    SF-36 health survey

    Measured: 108 weeks

  24. Anxiety and depression

    Hospital Anxiety and Depression Scale (HADS)

    Measured: 12 weeks

  25. Anxiety and depression

    Hospital Anxiety and Depression Scale (HADS)

    Measured: 48 weeks

  26. Anxiety and depression

    Hospital Anxiety and Depression Scale (HADS)

    Measured: 60 weeks

  27. Anxiety and depression

    Hospital Anxiety and Depression Scale (HADS)

    Measured: 108 weeks

  28. Perceived stress

    Perceived Stress Scale (PSS)

    Measured: 12 weeks

  29. Perceived stress

    Perceived Stress Scale (PSS)

    Measured: 48 weeks

  30. Perceived stress

    Perceived Stress Scale (PSS)

    Measured: 60 weeks

  31. Perceived stress

    Perceived Stress Scale (PSS)

    Measured: 108 weeks

  32. Irritable Bowel Syndrome Symptoms

    IBS Severity Scoring System (IBS-SSS)

    Measured: 12 weeks

  33. Irritable Bowel Syndrome Symptoms

    IBS Severity Scoring System (IBS-SSS)

    Measured: 48 weeks

  34. Irritable Bowel Syndrome Symptoms

    IBS Severity Scoring System (IBS-SSS)

    Measured: 60 weeks

  35. Irritable Bowel Syndrome Symptoms

    IBS Severity Scoring System (IBS-SSS)

    Measured: 108 weeks

  36. Hemogram

    leukocyte, hemoglobin, hematocrit, platelet

    Measured: 12 weeks

  37. Hemogram

    leukocyte, hemoglobin, hematocrit, platelet

    Measured: 48 weeks

  38. Hemogram

    leukocyte, hemoglobin, hematocrit, platelet

    Measured: 60 weeks

  39. Hemogram

    leukocyte, hemoglobin, hematocrit, platelet

    Measured: 108 weeks

  40. Blood sedimentation rate

    Measured: 12 weeks

  41. Blood sedimentation rate

    Measured: 48 weeks

  42. Blood sedimentation rate

    Measured: 60 weeks

  43. Blood sedimentation rate

    Measured: 108 weeks

  44. C-reactive protein

    Measured: 12 weeks

  45. C-reactive protein

    Measured: 48 weeks

  46. C-reactive protein

    Measured: 60 weeks

  47. C-reactive protein

    Measured: 108 weeks

  48. faecal calprotectin

    Measured: 12 weeks

  49. faecal calprotectin

    Measured: 48 weeks

  50. faecal calprotectin

    Measured: 60 weeks

  51. faecal calprotectin

    Measured: 108 weeks

  52. faecal lactoferrin

    Measured: 12 weeks

  53. faecal lactoferrin

    Measured: 48 weeks

  54. faecal lactoferrin

    Measured: 60 weeks

  55. faecal lactoferrin

    Measured: 108 weeks

  56. faecal polymorphonuclear (PMN)-elastase

    faecal polymorphonuclear elastase

    Measured: 12 weeks

  57. faecal PMN-elastase

    faecal polymorphonuclear elastase

    Measured: 48 weeks

  58. faecal PMN-elastase

    faecal polymorphonuclear elastase

    Measured: 60 weeks

  59. faecal PMN-elastase

    faecal polymorphonuclear elastase

    Measured: 108 weeks

  60. faecal human beta-defensin-2 (hBD-2)

    Measured: 12 weeks

  61. faecal hBD-2

    human beta-defensin-2

    Measured: 48 weeks

  62. faecal hBD-2

    human beta-defensin-2

    Measured: 60 weeks

  63. faecal hBD-2

    human beta-defensin-2

    Measured: 108 weeks

  64. Intestinal microbiota

    High-throughput 16S ribosomal ribonucleic acid (rRNA) gene sequencing

    Measured: 12 weeks

  65. Intestinal microbiota

    High-throughput 16S rRNA gene sequencing

    Measured: 48 weeks

  66. Intestinal microbiota

    High-throughput 16S rRNA gene sequencing

    Measured: 60 weeks

  67. Intestinal microbiota

    High-throughput 16S rRNA gene sequencing

    Measured: 108 weeks

  68. Intestinal permeability

    LactoseMonitol

    Measured: 12 weeks

  69. Intestinal permeability

    LactoseMonitol

    Measured: 48 weeks

  70. Intestinal permeability

    LactoseMonitol

    Measured: 60 weeks

  71. Intestinal permeability

    LactoseMonitol

    Measured: 108 weeks

  72. Adverse events

    Measured: 12 weeks

  73. Adverse events

    Measured: 48 weeks

  74. Adverse events

    Measured: 60 weeks

  75. Adverse events

    Measured: 108 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionOct 2019 (estimated)
  4. Study completionOct 2019 (estimated)

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02721823
Sponsor's protocol ID
15-6554-BO
Acronym
MBMCol
Status last verified
May 2017
First submitted
10 Feb 2016
Last updated
10 May 2017
Results posted
No
Data monitoring committee
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 40243391

  • Schlee C, Uecker C, Bauer N, Koch AK, Langhorst J. Multimodal stress reduction and lifestyle modification program for patients with ulcerative colitis: a qualitative study. BMC Complement Med Ther. 2022 Mar 8;22(1):60. doi: 10.1186/s12906-021-03478-w.

    PubMed 35260152

Questions about this trial

What is this clinical trial studying?

A study testing lifestyle-modification in people with Ulcerative Colitis, run by Universität Duisburg-Essen 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 May 2017. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jost Langhorst, Prof. Dr. med. (020117425012, j.langhorst@kliniken-essen-mitte.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-specific quality of life (time frame: 12 weeks). 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 NCT02721823, which also lists 2 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 10 May 2017; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in