Clinical trial NCT06145022: Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Official title: Effect of a Stress Reduction and Lifestyle Modification Programme on the Quality of Life of Irritable Bowel Syndrome Patients (MBM IBS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: lifestyle modification
Mind-Body medicine
integrative medicine
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: Bavarian State Ministry of Health and Care
First posted: 2023-11-22
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Severity of IBS symptoms by IBS-SSS
timeFrame: week 0
measure: Severity of IBS symptoms by IBS-SSS
timeFrame: week 12
measure: Severity of IBS symptoms by IBS-SSS
timeFrame: week 36
measure: overall change in health status
timeFrame: week 12
measure: overall change in health status
timeFrame: week 36
Secondary outcomes:
measure: Disease related Quality of Life by IBS-QOL
timeFrame: week 0
measure: Disease related Quality of Life by IBS-QOL
timeFrame: week 12
measure: Disease related Quality of Life by IBS-QOL
timeFrame: week 36
measure: General Quality of Life by EQ-5D-SL
timeFrame: week 0
measure: General Quality of Life by EQ-5D-SL
timeFrame: week 12
measure: General Quality of Life by EQ-5D-SL
timeFrame: week 36
measure: Stress: Perceived Stress (PSS-10)
timeFrame: week 0
measure: Stress: Perceived Stress (PSS-10)
timeFrame: week 12
measure: Stress: Perceived Stress (PSS-10)
timeFrame: week 36
measure: Stress: Coping Strategies (CISS)
timeFrame: week 0
measure: Stress: Coping Strategies (CISS)
timeFrame: week 12
measure: Stress: Coping Strategies (CISS)
timeFrame: week 36
measure: Core Self-Evaluation by CSES
timeFrame: week 0
measure: Core Self-Evaluation by CSES
timeFrame: week 12
measure: Core Self-Evaluation by CSES
timeFrame: week 36
measure: Utilization of medical services
timeFrame: week 0
measure: Utilization of medical services
timeFrame: week 12
measure: Utilization of medical services
timeFrame: week 36
measure: Days of work disability
timeFrame: week 0
measure: Days of work disability
timeFrame: week 12
measure: Days of work disability
timeFrame: week 36
measure: Anxiety and depression by HADS
timeFrame: week 0
measure: Anxiety and depression by HADS
timeFrame: week 12
measure: Anxiety and depression by HADS
timeFrame: week 36
measure: Qualitative Interviews
timeFrame: week 12
measure: Adverse events
timeFrame: week 12
measure: Adverse events
timeFrame: week 36
Other outcomes:
Locations:
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg
state: Bavaria
Study officials:
affiliation: University of Duisburg-Essen/Sozialstiftung Bamberg
name: Jost Langhorst, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: