Effect of a Stress Reduction and Lifestyle Modification Programme on the Quality of Life of Irritable Bowel Syndrome Patients (MBM IBS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- overall change in health status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of irritable bowel syndrome (IBS with diarrhea, IBS with constipation, mixed-type IBS, or unspecified IBS); IBS-SSS Score > 75
排除标准
- •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.
结局指标
主要结局
overall change in health status
时间窗: week 36
Rating scale from 1 (= much worse) to 5 (= much better)
Severity of IBS symptoms by IBS-SSS
时间窗: 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
次要结局
- 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: Perceived Stress (PSS-10)(week 36)
- Stress: Coping Strategies (CISS)(week 36)
- Days of work disability(week 36)
研究者
Jost Langhorst
Prof. Dr. med.
Universität Duisburg-Essen