A Mindfulness-based Stress Reduction Program for IBD

NCT ID: NCT07266883

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2027-02-01

Brief Summary

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 suggest that MBSR could improve their 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. We are studying people who are participating in an MBSR program as well as those receiving standard care at the QEII Health Sciences Centre. This study will assess how effective the MBSR program is compared to standard care at reducing distress and signs of stress and inflammation in people living with IBD. This study hopes 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.

Detailed Description

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 center around 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 centered on experiential learning and mindfulness practices called mindfulness-based stress reduction the promise of MBSR, many questions remain unanswered. Variability in IBD patient populations studied, 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 N.S. living with IBD. With this prospective observational cohort study, we 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've 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 education educational video or standard care + an 8 week MBSR program (MBSR-IBD). MBSR is 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, having a known diagnosis of IBD that is mildly to moderately active. 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.

Conditions

Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness based stress reduction

Intervention Type: BEHAVIORAL

Mindfulness based stress reduction (MBSR) course. Participants will complete this course, which will have weekly sessions over Zoom (group format) over 8 weeks. Homework exercises will also be part of the course.

Active Control

Will be asked to watch an educational video on stress reduction

Group Type: ACTIVE_COMPARATOR

Active Control

Intervention Type: OTHER

Educational stress reduction video

Interventions

Mindfulness based stress reduction

Mindfulness based stress reduction (MBSR) course. Participants will complete this course, which will have weekly sessions over Zoom (group format) over 8 weeks. Homework exercises will also be part of the course.

Intervention Type: BEHAVIORAL

Active Control

Educational stress reduction video

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• having a known diagnosis of IBD that is mildly to moderately active

Exclusion Criteria

• pediatric participants

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Countries

Canada

Central Contacts

Jennifer Jones, MD, FRCPC

Role: CONTACT

jljones@dal.ca

902-473-1499

Facility Contacts

Jennifer Jones, MD, FRCPC

Role: primary

jljones@dal.ca

902-473-1499

Other Identifiers

75285

Identifier Type: -

Identifier Source: org_study_id