Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
NCT ID: NCT06145022
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
118 participants
INTERVENTIONAL
2023-11-10
2025-07-31
Brief Summary
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Detailed Description
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Built on concepts like the Mind-Body Program and mindfulness-based stress reduction, the intervention incorporates elements from salutogenic and transtheoretical models and psychotherapeutic approaches.
Few integrative medicine approaches for IBS have undergone rigorous evaluation. IBS patients often experience reduced quality of life due to stress and psychosocial symptoms. The program, proven effective in inflammatory bowel diseases, covers stress reduction, dietary improvement, physical activity promotion, self-care applications, coping strategy training, and naturopathic treatments. Medically supervised, the group setting aims to enhance the intervention's impact through mutual support. Practical skills are demonstrated, and the goal is to empower patients for active, responsible, long-term management.
Participants in the waitlist control group receive a 1,5-hour educational session on lifestyle factors' influence and self-help materials. After week 36 measurements, they are offered participation in the multimodal program.
Questionnaires, a diary, and interviews will measure the outcomes of the study. Sociodemographics will be collected.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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intervention group
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.
lifestyle modification
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 mind / body medicine. In this project, this program will be adapted to the specific needs of irritable bowel syndrome patients.
waitlist control group
A unique education unit within the scope of 1,5 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.
waitlist control group
Participants in this group receive a one-time education unit within the scope of 1,5 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.
Interventions
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lifestyle modification
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 mind / body medicine. In this project, this program will be adapted to the specific needs of irritable bowel syndrome patients.
waitlist control group
Participants in this group receive a one-time education unit within the scope of 1,5 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Severe comorbid somatic illness (e.g., oncological disease)
* Pregnancy
* Participation in other stress reduction programs or clinical studies on psychological interventions
* Known intolerances (fructose, lactose), celiac disease, etc.
18 Years
75 Years
ALL
No
Sponsors
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Bavarian State Ministry of Health and Care
OTHER_GOV
Universität Duisburg-Essen
OTHER
Responsible Party
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Jost Langhorst
Prof. Dr. med.
Principal Investigators
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Jost Langhorst, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Duisburg-Essen/Sozialstiftung Bamberg
Locations
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Sozialstiftung Bamberg
Bamberg, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23065
Identifier Type: -
Identifier Source: org_study_id