MBMCrohn: Die Wirkung Eines Stressreduktion- Und Lebensstilmodifikations-programms Auf Die Lebensqualität Von Patienten Mit Morbus Crohn- Eine Machbarkeitsstudie
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Recruitment success
研究概览
简要总结
Patients with crohn's disease 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 in patients with uncreative colitis. The study will examine the promotion of the quality of life of patients with crohn's disease and the positive Influence on stress, psychological symptoms and physiological parameters.
详细描述
40 patients with ulcerative colitis will be randomized in an Intervention group and a control group for 10 weeks. The primary outcome is the feasibility of the study, the intervention and the examinations. The Secondary outcomes are disease-specific quality of life, disease-activity, stress, psychological symptoms, inflammatory parameters, disease activity parameters, bowel parameter and the microbiome. As qualitative parameters, the influence of the disease on everyday life and the experience/ impact/ implementability of the programme will be investigated. Lastly, undesirable events will be recorded.
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
- •age between 18 and 75 years
- •Presence of a confirmed diagnosis of Crohn's disease
- •In remission (not longer than 12 months, or mild to moderate clinical activity (HBI < 16)
- •Medication that has been stable for at least 3 months, regardless of whether glucocorticoids, immunosuppressive drugs, azathioprine, or other drug treatments according to MBMCrohn - Version 1.0 from 06.12.2019 Page 7 Guideline
- •Signed declaration of consent
排除标准
- •infectious or refractory Crohn's disease with severe course
- •Complete colectomy
- •Severe psychological illness (e.g. depression requiring treatment, addiction, schizophrenia)
- •Severe comorbid somatic disease (e.g. diabetes mellitus, oncological disease)
- •Pregnancy
- •Participation in stress reduction programmes or clinical studies on psychological interventions
研究组 & 干预措施
lifestyle-modification
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.
干预措施: lifestyle-modification (Behavioral)
waiting control group
A unique education unit within the scope of 3 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.
干预措施: waiting control group (Behavioral)
结局指标
主要结局
Recruitment success
时间窗: week 48
Proportion of people responding to appeals for studies
Attendance
时间窗: week 48
Proportion of people which actually attend the study
Willingness to participate
时间窗: week 48
Proportion of people which actually agreed in relation to the proportion of people which responded to the appeal.
Loss of participants over the study period
时间窗: week 48
Proportion of people who quit during the study
次要结局
- professional career (questionnaire)(week 0)
- calprotectin(week 48)
- creatinin(week 48)
- (PMN)-elastase(week 48)
- Generic quality of life by SF-36(week 0)
- Generic quality of life by SF 36(week 12)
- Disease activity 2 by BHI(week 0)
- Coping strategies by COPE(week 48)
- lymphocyte (T-cell) profiling(week 36)
- Flourishing by FS-D(week 48)
- Core Self-Evaluation by CSES(week 48)
- alpha-1- antitrypsin(week 12)
- intestinal microbiome(week 36)
- Intestinal permeability(week 0)
- qualitatives Interview(week 36)
- CRP (C-reactive protein)(week 48)
- Generic quality of life by SF36(week 48)
- Anxiety and depression by HADS(week 48)
- Perceived stress by PSS(week 48)
- Human beta-defensin-2 (hBD-2)(week 48)
- prolactin levels(week 12)
- heart rate(week 12)
- Adverse events(week 48)
- sex (questionnaire)(week 0)
- School career (questionnaire)(week 0)
- occupation (questionnaire)(week 0)
- Disease-specific quality of life by IBD-Q(week 48)
- lactoferrin(week 48)
- cortisol(week 12)
- ACTH(week 12)
- alpha-1-antitrypsin(week 48)
- Disease activity by HBI(week 48)
- BSG (blood cell sedimentation rate)(week 48)
- zonulin(week 48)
- glucocorticoid and β-adrenergic regulation of IL-8 and IL-10(week 12)
- TNF-α production by peripheral blood cells(week 12)
- blood pressure systolic and diastolic(week 12)
- STAI-S(week 12)
- marital status (questionnaire)(week 0)
- age (questionnaire)(week 0)
- weight(week 0)
- body height(week 0)
- job (questionnaire)(week 0)
- creatinin(week 12)
- Disease-specific quality of life by IBD-Q(week 0)
- Disease-specific quality of life by IBD-Q(week 12)
- Disease-specific quality of life by IBD-Q(week 36)
- Generic quality of life by SF36(week 36)
- Disease activity by HBI(week 12)
- Disease activity by HBI(week 36)
- Anxiety and depression by HADS(week 0)
- Anxiety and depression by HADS(week 12)
- Anxiety and depression by HADS(week 36)
- Perceived stress by PSS(week 0)
- Perceived stress by PSS(week 12)
- Perceived stress by PSS(week 36)
- Coping strategies by COPE(week 0)
- Coping strategies by COPE(week 12)
- Coping strategies by COPE(week 36)
- Flourishing by FS-D(week 0)
- CRP (C-reactive protein)(week 0)
- Flourishing by FS-D(week 12)
- Flourishing by FS-D(week 36)
- Core Self-Evaluation by CSES(week 0)
- Core Self-Evaluation by CSES(week 12)
- Core Self-Evaluation by CSES(week 36)
- CRP (C-reactive protein)(week 12)
- CRP (C-reactive protein)(week 36)
- BSG (blood cell sedimentation rate)(week 0)
- BSG (blood cell sedimentation rate)(week 12)
- BSG (blood cell sedimentation rate)(week 36)
- creatinin(week 0)
- creatinin(week 36)
- lymphocyte (T-cell) profiling(week 0)
- lymphocyte (T-cell) profiling(week 12)
- calprotectin(week 0)
- calprotectin(week 12)
- calprotectin(week 36)
- lactoferrin(week 0)
- lactoferrin(week 12)
- lactoferrin(week 36)
- (PMN)-elastase(week 0)
- (PMN)-elastase(week 12)
- (PMN)-elastase(week 36)
- Human beta-defensin-2 (hBD-2)(week 0)
- Human beta-defensin-2 (hBD-2)(week 12)
- Human beta-defensin-2 (hBD-2)(week 36)
- zonulin(week 0)
- zonulin(week 12)
- zonulin(week 36)
- alpha-1-antitrypsin(week 0)
- alpha-1-antitrypsin(week 36)
- intestinal microbiome(week 0)
- Adverse events(week 12)
- Adverse events(week 36)
研究者
Jost Langhorst
Clinical Professor
Universität Duisburg-Essen