Effect of a Stress Reduction and Lifestyle Modification Programme on the Quality of Life of Irritable Bowel Syndrome Patients (MBM IBS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Universität Duisburg-Essen
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Severity of IBS symptoms by IBS-SSS
Study Overview
Brief 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.
Detailed Description
The intervention is a 10-week multimodal stress reduction and lifestyle modification program consisting of 10 sessions, each lasting 6 hours. In groups of around 10 individuals, patients are comprehensively trained on the interplay between lifestyle and health, stress management, moderate physical activity (including yoga and Tai Chi), a Mediterranean diet, and self-help strategies. Successfully tested in two pilot studies, the program has evolved over 15 years and gained clinical experience in chronic inflammatory bowel diseases. It is now being applied to patients with irritable bowel syndrome (IBS).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •confirmed diagnosis of irritable bowel syndrome (IBS with diarrhea, IBS with constipation, mixed-type IBS, or unspecified IBS); IBS-SSS Score > 75
Exclusion Criteria
- •Severe mental illness (e.g., clinically significant depression, substance use disorder, schizophrenia)
- •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.
Arms & Interventions
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.
Intervention: lifestyle modification (Behavioral)
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.
Intervention: waitlist control group (Behavioral)
Outcomes
Primary Outcomes
Severity of IBS symptoms by IBS-SSS
Time Frame: week 36
Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: \< 175 for mild IBS, 175-300 for moderate IBS, and \> 300 for severe IBS
overall change in health status
Time Frame: week 36
Rating scale from 1 (= much worse) to 5 (= much better)
Severity of IBS symptoms by IBS-SSS
Time Frame: week 0
Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: \< 175 for mild IBS, 175-300 for moderate IBS, and \> 300 for severe IBS
Severity of IBS symptoms by IBS-SSS
Time Frame: week 12
Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: \< 175 for mild IBS, 175-300 for moderate IBS, and \> 300 for severe IBS
overall change in health status
Time Frame: week 12
Rating scale from 1 (= much worse) to 5 (= much better)
Secondary Outcomes
- Stress: Perceived Stress (PSS-10)(week 36)
- Days of work disability(week 36)
- Qualitative Interviews(week 12)
- Disease related Quality of Life by IBS-QOL(week 36)
- Core Self-Evaluation by CSES(week 36)
- Anxiety and depression by HADS(week 36)
- General Quality of Life by EQ-5D-SL(week 36)
- Adverse events(week 36)
- Utilization of medical services(week 36)
- Stress: Coping Strategies (CISS)(week 36)
- Disease related Quality of Life by IBS-QOL(week 0)
- Disease related Quality of Life by IBS-QOL(week 12)
- Utilization of medical services(week 12)
- General Quality of Life by EQ-5D-SL(week 0)
- General Quality of Life by EQ-5D-SL(week 12)
- Stress: Perceived Stress (PSS-10)(week 0)
- Stress: Perceived Stress (PSS-10)(week 12)
- Stress: Coping Strategies (CISS)(week 0)
- Stress: Coping Strategies (CISS)(week 12)
- Core Self-Evaluation by CSES(week 0)
- Core Self-Evaluation by CSES(week 12)
- Utilization of medical services(week 0)
- Days of work disability(week 0)
- Days of work disability(week 12)
- Anxiety and depression by HADS(week 0)
- Anxiety and depression by HADS(week 12)
- Adverse events(week 12)
Investigators
Jost Langhorst
Prof. Dr. med.
Universität Duisburg-Essen