Effect of a Stress Reduction and Lifestyle Modification Programme on the Quality of Life of Irritable Bowel Syndrome Patients (MBM IBS)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In the planned efficacy study, a prospective randomized controlled trial will be conducted to investigate the extent to which a multimodal stress reduction and lifestyle modification program can be reflected in patients with irritable bowel syndrome (IBS) within the framework of a clinical study. For this purpose, 118 patients with IBS will be enrolled in a clinical study. The intervention group will participate in a partial outpatient multimodal stress reduction and lifestyle modification program over 10 weeks, while the waitlist control group will only receive an educational session and written information on treatment and self-help options. The primary research question encompasses the examination of the program's impact on the severity of symptoms associated with irritable bowel syndrome (measured with the IBS-Symptom Severity Scale \[IBS-SSS\]) and additionally its influence on quality of life, stress, and mental well-being. Another aspect of the study is the utilization of medical services (e.g., comparing the number of doctor visits; intake of prescribed and over-the-counter medications). Additionally, a comparison of days of work disability will be conducted.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• confirmed diagnosis of irritable bowel syndrome (IBS with diarrhea, IBS with constipation, mixed-type IBS, or unspecified IBS); IBS-SSS Score \> 75

Locations
Other Locations
Germany
Sozialstiftung Bamberg
RECRUITING
Bamberg
Contact Information
Primary
Sandra Utz, PhD
sandra.utz@sozialstiftung-bamberg.de
+49 951 503
Backup
Christine Uecker
christine.uecker@sozialstiftung-bamberg.de
+49 951 503
Time Frame
Start Date: 2023-11-10
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 118
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Universität Duisburg-Essen
Collaborators: Bavarian State Ministry of Health and Care

This content was sourced from clinicaltrials.gov