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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Jennifer Jones, MD, FRCPC
- Phone Number: 902-473-1499
- Email: jljones@dal.ca
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
- QEII Health Sciences Centre
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Contact:
- Jennifer Jones, MD, FRCPC
- Phone Number: 902-473-1499
- Email: jljones@dal.ca
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Principal Investigator:
- Jennifer Jones, MD, FRCPC
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Active Comparator: Active Control
Will be asked to watch an educational video on stress reduction
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Educational stress reduction video
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Psychological distress (GAD7)
Time Frame: Visit 1 (2 months post enrollment)
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Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale.
Score ranges from 0-21.
Higher scores are worse.
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Visit 1 (2 months post enrollment)
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Psychological distress (GAD7)
Time Frame: Visit 2 (6 months post enrollment)
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Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale.
Score ranges from 0-21.
Higher scores are worse.
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Visit 2 (6 months post enrollment)
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Psychological distress (PHQ9)
Time Frame: Visit 1 (2 months post enrollment)
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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.
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Visit 1 (2 months post enrollment)
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Psychological distress (PHQ9)
Time Frame: Visit 2 (6 months post enrollment)
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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.
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Visit 2 (6 months post enrollment)
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IBD-related quality of life score (SIBDQ)
Time Frame: Visit 1 (2 months post enrollment)
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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
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Visit 1 (2 months post enrollment)
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IBD-related quality of life score (SIBDQ)
Time Frame: Visit 2 (6 months post enrollment)
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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.
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Visit 2 (6 months post enrollment)
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General quality of life score (SF-36)
Time Frame: Visit 1 (2 months post enrollment)
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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.
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Visit 1 (2 months post enrollment)
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General quality of life score (SF-36)
Time Frame: Visit 2 (6 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.
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Visit 2 (6 months post enrollment)
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mindfulness (FFMQ)
Time Frame: Visit 1 (2 months post enrollment)
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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.
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Visit 1 (2 months post enrollment)
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Mindfulness (FFMQ)
Time Frame: Visit 2 (6 months post enrollment)
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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.
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Visit 2 (6 months post enrollment)
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Resilience (CD-RISC)
Time Frame: Visit 1 (2 months post enrollment)
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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.
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Visit 1 (2 months post enrollment)
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Resilience (CD-RISC)
Time Frame: Visit 2 (6 months post enrollment)
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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.
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Visit 2 (6 months post enrollment)
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Participant self-efficacy score (NGSE Scale)
Time Frame: Visit 1 (2 months post enrollment)
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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.
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Visit 1 (2 months post enrollment)
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Participant Self efficacy score (NGSE Scale)
Time Frame: Visit 2 (6 months post enrollment)
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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.
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Visit 2 (6 months post enrollment)
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Psychological Flexibility (compACT)
Time Frame: Visit 1 (2 months post enrollment)
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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).
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Visit 1 (2 months post enrollment)
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Psychological Flexibility (compACT)
Time Frame: Visit 2 (6 months post enrollment)
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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).
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Visit 2 (6 months post enrollment)
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Participant Fatigue (FACIT-F)
Time Frame: Visit 1 (2 months post enrollment)
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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
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Visit 1 (2 months post enrollment)
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Participant Fatigue (FACIT-F)
Time Frame: Visit 2 (6 months post enrollment)
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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.
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Visit 2 (6 months post enrollment)
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Fecal microbial diversity
Time Frame: Visit 1 (8 weeks post enrollment)
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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.
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Visit 1 (8 weeks post enrollment)
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Fecal microbial diversity
Time Frame: Visit 2 (6 months post enrollment)
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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.
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Visit 2 (6 months post enrollment)
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Fecal microbial abundance
Time Frame: Visit 1 (2 months post enrollment)
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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.
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Visit 1 (2 months post enrollment)
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Fecal microbial abundance
Time Frame: Visit 2 (6 months post enrollment)
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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.
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Visit 2 (6 months post enrollment)
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
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
Other Study ID Numbers
- 75285
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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