A Mindfulness-based Stress Reduction Program for IBD

NCT07266883 | Not Yet Recruiting

• 1 other identifier: 75285
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

IBD; psychological distress; mindfulness

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (14)

• Mindfulness (FFMQ)

  Visit 1 (2 months post enrollment)

• Mindfulness (FFMQ)

  Visit 2 (6 months post enrollment)

• Resilience (CD-RISC)

  Visit 1 (2 months post enrollment)

• Resilience (CD-RISC)

  Visit 2 (6 months post enrollment)

• Participant self-efficacy score (NGSE Scale)

  Visit 1 (2 months post enrollment)

Study Arms (2)

MBSR group

EXPERIMENTAL

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

Active Control

ACTIVE COMPARATOR

Will be asked to watch an educational video on stress reduction

Other: Active Control

Interventions

Mindfulness based stress reduction BEHAVIORAL

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.

MBSR group

Active Control OTHER

Educational stress reduction video

Active Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pediatric participants

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Jennifer Jones, MD, FRCPC

CONTACT

902-473-1499; jljones@dal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: December 5, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-09

Locations

CA (1)