Randomized Controlled Trial on the Effect of Stress Reduction and Lifestyle Modification on Disease Activity in Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Disease-specific quality of life
研究概览
简要总结
Patients with ulcerative colitis often suffer significant limitations to their quality of life, which are also conditioned by particular stress and psychosocial accompanying symptoms of the disease. A multimodal program for stress-reduction and lifestyle-modification has been shown to be effective in promoting the quality of life. The study will examine the promotion of the quality of life of patients with ulcerative colitis and the positive Influence on stress, psychological symptoms and physiological parameters. 92 patients with ulcerative colitis will be randomized in an Intervention group and a control group for 10 weeks. The primary outcome is the disease-specific quality of life, the secondary outcomes are stress, psychological symptoms, inflammatory parameters, disease activity parameters, bowel parameter and the microbiome.
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
- Single (Outcomes Assessor)
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
- •18 to 75 years
- •diagnosis of ulcerative colitis
- •Currently in remission, remission not longer than 12 months
- •limited quality of life or increased subjective stress level
排除标准
- •Infectious or chronic active ulcerative colitis
- •Taking glucocorticoids or immunosuppressants within the last 3 months, except stable medication using azathioprine
- •colectomy
- •serious psychological disorder (for example: major depression, addiction, schizophrenia)
- •serious comorbid somatic disease (for example: diabetes mellitus, oncological disease)
- •pregnancy
- •participation in stress reduction program or clinical studies to psychological interventions
结局指标
主要结局
Disease-specific quality of life
时间窗: 12 weeks
Inflammatory Bowel Disease Questionnaire (IBD-Q)
次要结局
- Irritable Bowel Syndrome Symptoms(108 weeks)
- Histology(108 weeks)
- Generic quality of life(108 weeks)
- Hemogram(108 weeks)
- faecal calprotectin(108 weeks)
- faecal lactoferrin(108 weeks)
- Perceived stress(108 weeks)
- Blood sedimentation rate(108 weeks)
- faecal PMN-elastase(108 weeks)
- Adverse events(108 weeks)
- Endoscopic index(108 weeks)
- Anxiety and depression(108 weeks)
- faecal polymorphonuclear (PMN)-elastase(12 weeks)
- faecal hBD-2(108 weeks)
- Intestinal permeability(108 weeks)
- Disease-specific quality of life(108 weeks)
- faecal human beta-defensin-2 (hBD-2)(12 weeks)
- Intestinal microbiota(108 weeks)
- C-reactive protein(108 weeks)
- Disease activity(108 weeks)
研究者
Jost Langhorst
Medical vice director
Universität Duisburg-Essen