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临床试验/NCT04646785
NCT04646785已完成不适用

Mindfulness-based Cognitive Therapy to Improve Stress and Sleep in Patients With Inflammatory Bowel Disease

Radboud University Medical Center5 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
142
试验地点
5
主要终点
Psychological distress

研究概览

简要总结

Considering the limited availability of psychosocial interventions for IBD, this study aims to investigate MBCT as an adjunctive treatment to treatment as usual to reduce psychological stress and improve sleep quality/regularity in patients with IBD who report elevated stress levels. The study will have a follow-up duration of 12 months from baseline.

详细描述

Introduction:

Inflammatory bowel diseases (IBD) are chronic inflammatory diseases of the intestinal tract, consisting of crohn's disease (CD) and ulcerative colitis (UC). In The Netherlands, there are about 90,000 IBD patients, mainly young adults who are in a turbulent part of their life with starting a family and career. The prevalence of IBD seems to be rising. The peak incidence is between 15 and 30 years. The disease is characterized by periods of disease activity (flares) alternating with periods of (clinical) remission. Physical symptoms include abdominal pain, diarrhea, rectal bleeding and fatigue. Although the arsenal of drugs has increased in recent decades, there is no cure for the disease and patients are usually long-term treated with different (immunosuppressive) medications. Nevertheless, at this moment, we are only partially able to keep our IBD patients in remission.

Even in those in remission, IBD is associated with increased levels of psychological stress, with estimated prevalence rates of 21% for depressive symptoms and 35% for anxiety symptoms. In periods of disease activity, prevalence of elevated anxiety levels was even found to be as high as 75.6%. Besides psychological stress, IBD patients in remission report lower quality of life compared to the general population. This is due to the physical symptoms but also to fatigue, worries, anxiety, depression, impaired satisfaction with social role and sleep disturbances. More than 40 % of the IBD patients experience fatigue. This may contribute to the higher sick leave days and higher work impairment rates in quiescent IBD, causing high societal costs. In addition, poor sleep seems common in individuals with IBD and has been linked to disease activity and shown as a predictor for subclinical inflammation and a risk factor for relapse and poorer outcomes.

Mindfulness training, typically in the form of mindfulness-based stress reduction (MBSR) or mindfulness-based cognitive therapy (MBCT), is a psychosocial group-based intervention that has been shown to reduce psychological distress and improving quality of life, both in patients with mental health problems and those with chronic diseases such as diabetes, cancer, cardiovascular disease, rheumatoid arthritis and fibromyalgia. Mindfulness training focuses on the progressive acquisition of mindful awareness to better cope with negative repetitive thoughts and feelings, and for that reason may be a good option to reduce psychological stress and fatigue, and improve quality of life in patients with chronic conditions including IBD.

Although the available literature on the effectiveness of mindfulness-based interventions for IBD is still relatively scarce, a recent meta-analysis showed significant benefits in terms of stress, depression, and quality of life. However, the variety in types of interventions was rather high, and individual studies typically suffered from methodological limitations, including small sample size, poor blinding of the outcome assessors, incomplete data reporting and a relative lack of fidelity measures. Therefore, it seems warranted to conduct a high-quality, multicenter randomized controlled trial investigating the effectiveness of MBCT to improve stress, sleep quality, and quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed IBD diagnosis of Crohn's disease (CD), Ulcerative colitis (UC) or Indeterminate colitis (IC)
  • Current IBD remission (Calprotectin < 250 mg/kg) since at least three months
  • Hospital Anxiety and Depression Scale-score of >=11, indicating at least mild levels of psychological distress (Vodermaier 2011).
  • Age of 16 or older
  • Taking no IBD medication or on a stable dose of 5-ASA products, immunosuppressive medication, or biologics for at least three months prior to enrollment.

排除标准

  • Severe psychiatric disorders (e.g. acute suicidality, psychosis)
  • Current alcohol or drug dependency
  • Untreated anemia
  • Prior participation in an 8-week MBSR or MBCT-programme

结局指标

主要结局

Psychological distress

时间窗: Change between 3 and 12 months

Measured by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, 7 related to depression and 7 related to anxiety. Scoring for each item ranges from zero to three. Three denotes highest anxiety or depression level meaning that a person can score between 0 and 21 for either anxiety or depression.

次要结局

  • Calprotectin(Change between 3 and 12 months)
  • Objective sleep quality(Change between 3 and 12 months)
  • Perceived control over IBD(Change between 3 and 12 months)
  • Self-compassion(Change between 3 and 12 months)
  • IBD-related quality of life(Change between 3 and 12 months)
  • Positive mental health(Change between 3 and 12 months)
  • Subjective sleep quality(Change between 3 and 12 months)
  • C-reactive protein levels(Change between 3 and 12 months)
  • Mindfulness skills(Change between 3 and 12 months)
  • Fatigue(Change between 3 and 12 months)
  • Clinical disease activity(change between 3 and 12 months)
  • Repetitive negative thinking(Change between 3 and 12 months)
  • Costs(12 months)
  • Health-related quality of life(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Speckens

Principal Investigator and Director of Radboudumc Centre for Mindfulness

Radboud University Medical Center

研究点 (5)

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