A Mindfulness-based Stress Reduction Program for IBD

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.

• Mindfulness (FFMQ) [Time frame: Visit 1 (2 months post enrollment)]
• Mindfulness (FFMQ) [Time frame: Visit 2 (6 months post enrollment)]
• Resilience (CD-RISC) [Time frame: Visit 1 (2 months post enrollment)]
• Resilience (CD-RISC) [Time frame: Visit 2 (6 months post enrollment)]
• Participant self-efficacy score (NGSE Scale) [Time frame: Visit 1 (2 months post enrollment)]
• Participant Self efficacy score (NGSE Scale) [Time frame: Visit 2 (6 months post enrollment)]
• Psychological Flexibility (compACT) [Time frame: Visit 1 (2 months post enrollment)]
• Psychological Flexibility (compACT) [Time frame: Visit 2 (6 months post enrollment)]
• Participant Fatigue (FACIT-F) [Time frame: Visit 1 (2 months post enrollment)]
• Participant Fatigue (FACIT-F) [Time frame: Visit 2 (6 months post enrollment)]
• Fecal microbial diversity [Time frame: Visit 1 (8 weeks post enrollment)]
• Fecal microbial diversity [Time frame: Visit 2 (6 months post enrollment)]