NCT05182645

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2020

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

1.7 years

First QC Date

August 11, 2020

Last Update Submit

November 14, 2022

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (4)

  • Recruitment success

    Proportion of people responding to appeals for studies

    week 48

  • Willingness to participate

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

    week 48

  • Attendance

    Proportion of people which actually attend the study

    week 48

  • Loss of participants over the study period

    Proportion of people who quit during the study

    week 48

Secondary Outcomes (95)

  • Disease-specific quality of life by IBD-Q

    week 0

  • Disease-specific quality of life by IBD-Q

    week 12

  • Disease-specific quality of life by IBD-Q

    week 36

  • Disease-specific quality of life by IBD-Q

    week 48

  • Generic quality of life by SF-36

    week 0

  • +90 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: waiting control group

Interventions

lifestyle-modificationBEHAVIORAL

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.

lifestyle-modification
waiting control groupBEHAVIORAL

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.

waiting control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sozialstiftung Bamberg, Klinik für Intergrative Medizin

Bamberg, Bavaria, 96049, Germany

Location

Related Publications (4)

  • 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.

    PMID: 40243391DERIVED

  • Schlee 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.

    PMID: 39536026DERIVED

  • Mekes-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.

    PMID: 39102712DERIVED

  • 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.

    PMID: 36081609DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Jost Langhorst, Prof.

    Sozialstiftung Bamberg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Waiting Control Group Design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 11, 2020

First Posted

January 10, 2022

Study Start

July 1, 2020

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

November 15, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)