A Mindfulness-based Stress Reduction Program for IBD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Scotia Health Authority
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
having a known diagnosis of IBD that is mildly to moderately active
Disqualifiers
Pediatric participants
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness based stress reduction
BehavioralA 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
Other interventionEducational stress reduction video
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: MBSR groupExperimental treatment 1 intervention
Group B: Active ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Psychological distress (GAD7)
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale. Score ranges from 0-21. Higher scores are worse.
Time frame
Visit 1 (2 months post enrollment)2
Psychological distress (GAD7)
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale. Score ranges from 0-21. Higher scores are worse.
Time frame
Visit 2 (6 months post enrollment)3
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.
Time frame
Visit 1 (2 months post enrollment)4
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.
Time frame
Visit 2 (6 months post enrollment)Secondary outcomes
1
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.
Time frame
Visit 1 (2 months post enrollment)2
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.
Time frame
Visit 2 (6 months post enrollment)3
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.
Time frame
Visit 1 (2 months post enrollment)4
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.
Time frame
Visit 2 (6 months post enrollment)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: