Targeting the Brain-gut Axis in Inflammatory Bowel Diseases: Implementation and Exploration of Mechanism and Early Effectiveness of a Mindfulness-based Stress Reduction Program
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- IBD Related quality of life score (SIBDQ)
研究概览
简要总结
The gut-brain connection is important for good health and when it is disrupted it can worsen existing chronic disease. Studies have shown that chronic stress has negative effects on the gastrointestinal tract such as inflammation and disruption of the beneficial bacteria that live there. These negative effects of chronic stress can lead to flare-ups of IBD. Mindfulness-based stress reduction (MBSR) is a structured 8 week program that aims to reduce stress by teaching mindfulness techniques. Recent research in people living with IBD suggests that MBSR could improve one's quality of life by reducing stress levels. The study aims to investigate the effects of MBSR on both the mental health of people living with IBD, and their physical health. The investigators are studying people who are participating in an MBSR program as well as those receiving standard of care at the QEII Health Sciences Centre. This study will assess how effective the MBSR program is compared to standard of care at reducing distress and signs of stress and inflammation in people living with IBD. This study aims to provide valuable insights into how mindfulness techniques could be used to support individuals living with IBD. Ultimately, this research aims to improve quality of life and health outcomes for people affected by this challenging condition.
详细描述
Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic immune-mediated diseases that affect the gastrointestinal tract most often diagnosed in the second and third decades of life. IBD can have a deleterious impact on one's personal life, work and career trajectory, and mental and physical health over time. Untreated, IBD often leads to significant impairments in quality of life related to the effect of the disease on both mental and physical health. More than 30 percent of people living with IBD are also struggling with some form of psychological distress (PD) at any given time, which may be a result of the disease or independent of IBD. Forms of PD include, but are not limited to, anxiety, depression, and disease-related stress. Although psychotherapy interventions have been the main focus for management of psychological distress in IBD, a growing body of literature focusing on mindfulness-based interventions (MBIs) in IBD exists. MBI interventions focus on the development of greater capacity for "awareness that arises through paying attention, on purpose, in the present moment, non-judgementally." Greater capacity to default to present moment awareness rather than a future focus, specifically, excessive worrying (fuels anxiety) or backward gazing, specifically ruminating (predisposes to depression) has the potential to significantly improve chronic disease-related distress in persons living with IBD. One of the most well-defined, evidence-based MBIs is a structured, standardized, 8-week curriculum focused on experiential learning and mindfulness practices called mindfulness-based stress reduction (MBSR). Despite the promise of MBSR, many questions remain unanswered. Variability in IBD patient populations studied, the nature and severity of psychological distress, outcome measures, study design, and overall lack of mechanistic research in IBD are all gaps in existing research that need to be addressed. The benefit of MBSR to target the brain-gut axis and as an adjunctive therapy is also unclear. The Nova Scotia Collaborative IBD Program is running an 8-week MBSR program for people in Nova Scotia living with IBD. With this prospective observational cohort study, the investigators plan to evaluate how effective this program is in improving quality of life and reducing stress biomarkers and psychological stress scores for adult patients with IBD. This study will compare health outcomes of patients who participated in an MBSR program run by qualified MBSR teachers affiliated with the NSCIBD to a group of patients who have received standard of care. The overall objectives of this study are to: 1. Evaluate the early effectiveness of the 8-week MBSR program and 2. Collect and analyze biological and microbial markers of systemic and intestinal inflammation to understand MBSR-mediated psychological, disease-related, immunologic, neurohormonal, and microbiome impacts in persons living with mild to moderately active IBD compared to controls. This will be an open-label, comparator-controlled study in which patients with IBD will undergo random allocation to either standard of care + a stress reduction educational video or standard of care + an 8 week MBSR program (MBSR-IBD). MBSR is a skills-based, experiential learning program in which participants attend weekly 2.5 hour sessions for 8 weeks plus one full day weekend session. Over the course of these sessions, participants learn mindfulness-based skills including, but not limited to, formal and informal meditation. Inclusion criteria include participants 18 years of age or older and a known diagnosis of mild to moderately active IBD. Health outcome data on clinical disease activity, microbial diversity, and cytokine arrays will be prospectively collected. Psychological questionnaires will also be collected. Data on disease activity, duration, phenotype, as well as medication and surgical history will be collected via targeted chart review.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •having a known diagnosis of IBD that is mildly to moderately active
排除标准
- •Pediatric participants
研究组 & 干预措施
MBSR group
Will participate in an 8 week mindfulness-based stress reduction course, administered by a trained professional (clinician), virtually (zoom) with sessions once weekly and homework exercises. Group format.
干预措施: Mindfulness based stress reduction (Behavioral)
Active Control
Will be asked to watch an educational video on stress reduction
干预措施: Active Control (Other)
结局指标
主要结局
IBD Related quality of life score (SIBDQ)
时间窗: Visit 1 (2 months post enrollment)
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Psychological distress (GAD7)
时间窗: Visit 1 (2 months post enrollment)
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale. Score ranges from 0-21. Higher scores are worse.
Psychological distress (PHQ9)
时间窗: Visit 1 (2 months post enrollment)
Participant psychological distress, measured by the nine-item Patient Health Questionnaire (PHQ9). This questionnaire measures depression symptom severity. Score range: 0 to 27. Higher scores indicate more severe depressive symptoms.
General quality of life score (SF-36)
时间窗: Visit 1 (2 months post enrollment)
General quality of life score, measured by the SF-36 questionnaire. The summary scores range from 0 to 100. Higher scores indicate better perceived health/functioning.
IBD-related quality of life score (SIBDQ)
时间窗: Visit 1 (2 months post enrollment)
IBD-related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Score range: 10 to 70. Higher scores indicate better quality of life
IBD-related quality of life score (SIBDQ)
时间窗: Visit 2 (6 months post enrollment)
IBD-related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Score range: 10 to 70. Higher scores indicate better quality of life.
Psychological distress (GAD7)
时间窗: Visit 2 (6 months post enrollment)
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale. Score ranges from 0-21. Higher scores are worse.
Psychological distress (PHQ9)
时间窗: Visit 2 (6 months post enrollment)
Participant psychological distress, measured by the nine-item nine-item Patient Health Questionnaire-9 (PHQ-9). This questionnaire measures depression symptom severity. Score range: 0 to 27. Higher scores indicate more severe depressive symptoms.
General quality of life score (SF-36)
时间窗: Visit 2 (6 months post enrollment)
General quality of life score, measured by the SF-36 questionnaire. The summary scores range from 0 to 100. Higher scores indicate better perceived health/functioning.
IBD Related quality of life score (SIBDQ)
时间窗: Visit 2 (6 months post enrollment)
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
次要结局
- Participant Self efficacy score (NGSE Scale)(Visit 1 (2 months post enrollment))
- Mindfulness (FFMQ)(Visit 1 (2 months post enrollment))
- Resilience (CD-RISC)(Visit 1 (2 months post enrollment))
- Psychological Flexibility (compACT)(Visit 1 (2 months post enrollment))
- Participant Fatigue (FACIT-F)(Visit 1 (2 months post enrollment))
- Fecal microbial diversity(Visit 1 (8 weeks post enrollment))
- Fecal microbial abundance(Visit 1 (2 months post enrollment))
- Participant self-efficacy score (NGSE Scale)(Visit 1 (2 months post enrollment))
- Mindfulness (FFMQ)(Visit 2 (6 months post enrollment))
- Participant Self efficacy score (NGSE Scale)(Visit 2 (6 months post enrollment))
- Fecal microbial abundance(Visit 2 (6 months post enrollment))
- Fecal microbial diversity(Visit 2 (6 months post enrollment))
- Resilience (CD-RISC)(Visit 2 (6 months post enrollment))
- Psychological Flexibility (compACT)(Visit 2 (6 months post enrollment))
- Participant Fatigue (FACIT-F)(Visit 2 (6 months post enrollment))
