A Mindfulness-based Stress Reduction Program for IBD (MBSRforIBD)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis)
• Intervention / Treatment: Other: Active Control; Behavioral: Mindfulness based stress reduction

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Jones, MD, FRCPC; Phone Number: 902-473-1499; Email: jljones@dal.ca

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • QEII Health Sciences Centre
      • Contact: Jennifer Jones, MD, FRCPC; Phone Number: 902-473-1499; Email: jljones@dal.ca
      • Principal Investigator: Jennifer Jones, MD, FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pediatric participants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Control; Will be asked to watch an educational video on stress reduction	Other: Active Control; Educational stress reduction video
Experimental: 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.	Behavioral: Mindfulness 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological distress (GAD7)	Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale. Score ranges from 0-21. Higher scores are worse.	Visit 1 (2 months post enrollment)
Psychological distress (GAD7)	Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale. Score ranges from 0-21. Higher scores are worse.	Visit 2 (6 months post enrollment)
Psychological distress (PHQ9)	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.	Visit 1 (2 months post enrollment)
Psychological distress (PHQ9)	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.	Visit 2 (6 months post enrollment)
IBD-related quality of life score (SIBDQ)	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	Visit 1 (2 months post enrollment)
IBD-related quality of life score (SIBDQ)	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.	Visit 2 (6 months post enrollment)
General quality of life score (SF-36)	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.	Visit 1 (2 months post enrollment)
General quality of life score (SF-36)	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.	Visit 2 (6 months post enrollment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mindfulness (FFMQ)	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.	Visit 1 (2 months post enrollment)
Mindfulness (FFMQ)	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.	Visit 2 (6 months post enrollment)
Resilience (CD-RISC)	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.	Visit 1 (2 months post enrollment)
Resilience (CD-RISC)	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.	Visit 2 (6 months post enrollment)
Participant self-efficacy score (NGSE Scale)	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.	Visit 1 (2 months post enrollment)
Participant Self efficacy score (NGSE Scale)	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.	Visit 2 (6 months post enrollment)
Psychological Flexibility (compACT)	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).	Visit 1 (2 months post enrollment)
Psychological Flexibility (compACT)	Participant psychological flexibility, measured by the Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT). Score range: 0 to 92 (items scored on a 5-point scale with some reverse-scored. Higher scores indicate greater psychological flexibility (a strength).	Visit 2 (6 months post enrollment)
Participant Fatigue (FACIT-F)	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	Visit 1 (2 months post enrollment)
Participant Fatigue (FACIT-F)	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.	Visit 2 (6 months post enrollment)
Fecal microbial diversity	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.	Visit 1 (8 weeks post enrollment)
Fecal microbial diversity	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.	Visit 2 (6 months post enrollment)
Fecal microbial abundance	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.	Visit 1 (2 months post enrollment)
Fecal microbial abundance	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.	Visit 2 (6 months post enrollment)

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: September 10, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: mindfulness; IBD; psychological distress
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness; Mindfulness-Based Stress Reduction
• Other Study ID Numbers: 75285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No