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A Mindfulness-based Stress Reduction Program for IBD

Targeting the Brain-gut Axis in Inflammatory Bowel Diseases: Implementation and Exploration of Mechanism and Early Effectiveness of a Mindfulness-based Stress Reduction Program

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07266883
Acronym
MBSRforIBD
Enrollment
70
Registered
2025-12-05
Start date
2027-09-01
Completion date
2028-02-01
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

IBD, psychological distress, mindfulness

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 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.

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 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.

Interventions

BEHAVIORALMindfulness based stress reduction

A 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.

OTHERActive Control

Educational stress reduction video

Sponsors

Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Pediatric participants

Design outcomes

Primary

MeasureTime frameDescription
Psychological distress (GAD7)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)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.
IBD-related quality of life score (SIBDQ)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
General quality of life score (SF-36)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.

Secondary

MeasureTime frameDescription
Mindfulness (FFMQ)Visit 1 (2 months post enrollment)Participant mindfulness, measured by the Five Facet Mindfulness Questionnaire (FFMQ). The 39-item FFMQ total score ranges from 39 to 195, with higher scores indicating greater dispositional mindfulness.
Resilience (CD-RISC)Visit 1 (2 months post enrollment)Participant psychological resilience, measured by the Connor-Davidson Resilience Scale (CD-RISC). Total scores range from 0 to 100, with higher scores indicating greater resilience.
Participant self-efficacy score (NGSE Scale)Visit 1 (2 months post enrollment)Self-efficacy, measured by the New General Self-Efficacy Scale. Score range: 10 to 40 (each item scored 1-4). Higher scores indicate greater self-efficacy.
Participant Self efficacy score (NGSE Scale)Visit 2 (6 months post enrollment)Self-efficacy, measured by the New General Self Efficacy Scale (NGSE Scale). Score range: 10 to 40 (each item scored 1-4). Higher scores indicate greater self-efficacy.
Psychological Flexibility (compACT)Visit 1 (2 months post enrollment)Participant psychological flexibility, measured by the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT) scale. Score range: 0 to 92 (items scored on a 5-point scale with some reverse-scored. Higher scores indicate greater psychological flexibility (a strength).
Participant Fatigue (FACIT-F)Visit 1 (2 months post enrollment)Participant fatigue as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scale. Total scores range from 0 to 52, with higher scores indicating less fatigue and better functioning
Fecal microbial diversityVisit 1 (8 weeks post enrollment)Participant fecal microbial diversity, measured as laboratory based estimates of alpha diversity, beta-diversity, from processed fecal samples. Higher alpha diversity values are generally associated with greater microbial richness and ecological stability. Beta diversity reflects differences in microbial community composition between samples and is interpreted relative to comparator groups.
Fecal microbial abundanceVisit 1 (2 months post enrollment)Participant fecal microbial abundance, measured as laboratory-based estimates of relative abundance of individual amplicon sequence variants (ASVs) from processed fecal samples. Relative abundance values reflect the proportional representation of specific taxa within the microbial community and are interpreted in the context of the specific organism identified.

Countries

Canada

Contacts

CONTACTJennifer Jones, MD, FRCPC
jljones@dal.ca902-473-1499

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026