Clinical trial NCT04302623: Meditation and Yoga for Irritable Bowel Syndrome
Official title: Meditation and Yoga for Irritable Bowel Syndrome Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Yoga
Meditation
Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Yoga
Meditation
eHealth
Quality of Life
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Study Aim: This study will explore the feasibility and effectiveness of a yoga program for patients with IBS.

Methods: A superiority RCT with 30 participants per group. Adult patients with IBS fluent in English who do not have major physical impairments or cognitive, psychological, or psychiatric disorder will be recruited and randomly using the REDCap randomization module to either a yoga intervention delivered (a) a yoga intervention delivered online led by a yoga facilitator or (b) a advice only control group. The 8-week Hatha Yoga intervention consists of Yoga Namaskar, Nadi Shuddhi (alternate nostril breathing), mantra chanting, and breath watching.

Group 1: Yoga program. Participants will be asked to practice the yoga program daily at home and will be given access to the yoga videos hosted on the University of Calgary study website, as well as written program instructions, and frequently answered questions. A brief description of the video content will be provided to inform the participant of its content and length. Additional website content will include study information, study schedule, and contact information, as well as a pre-recorded educational session. In addition to the daily program describe above, the facilitator-led intervention will be delivered online by a certified yoga facilitator using the Microsoft Teams platform. Participants in group of 3 to 5 will be collated to enhance effectiveness of the study processes. Our team has experience with this approach, as this strategy is currently used with previous yoga study. Yoga classes will be held once per week for 8 weeks, with the first session lasting approximately 1.5 hours and subsequent sessions up to 60 minutes. The total allocated time for the introductory session will include the class set-up, introductions, educational material (please see below), overview of practices, teaching of practices, practice corrections/enhancements, modifications, and practice expectations. Each follow-up class will include review from the previous week, questions and answers, individual corrections and/or modifications. For individual corrections, the yoga facilitator will ask the participant to do the practices and receive corrections, if needed.

Group 2. Advice-only control group. This group will receive general education on IBS, the mind and gut connection, and the role of mind-body therapies in the management of IBS.

Effectiveness outcomes will be assessed at baseline and 8 weeks. The primary effectiveness outcome will be the severity of IBS symptoms, and secondary effectiveness outcomes include microbiome analysis, quality of life, anxiety and depression symptoms, perceived stress, fatigue, and severity of somatic symptoms. Microbiome composition will be measured using shotgun metagenomic sequencing. Microbiome sequences will be analyzed for alpha diversity, beta diversity, species composition, functional composition and biomarker discovery. To determine the feasibility of each intervention, recruitment and attrition rates, adherence, program preferences and satisfaction, and adverse event outcomes will be evaluated.

Detailed description: Study Aim. This study will explore the feasibility and effectiveness of a yoga program for patients with IBS. Objective. Examine the feasibility and effectiveness of an 8-week online live facilitator-led yoga program compared to a wait-list control. Hypothesis. Yoga delivered online live by a facilitator will have the superior effectiveness in reducing IBS symptoms compared to advice only control group after 8 weeks.

Background

IBS is a highly prevalent disorder affecting 12% of Canadians. One in five individuals with IBS has one or more psychiatric disorder, and 50% have at least one comorbid somatic symptom. Frequently used therapies are targeted toward symptom reduction with modest benefits, whereas treatments with greater therapeutic effect may be associated with side effects. This leaves many patients dissatisfied with their symptom management, resulting in half of patients using alternative therapies. The underlying cause of IBS is likely multifactorial and the interplay of the brain-gut axis in the pathophysiology of IBS has been well established. An altered stress response, arising through either psychological and/or physiological mechanisms is hypothesized to be involved in the impairment of the signalling between the brain and the gut. This demonstrates a connection between gut function, stress, and psychological processes. Therefore, therapies that focus on mind-body interactions and stress reduction, may be useful adjunctive treatments for IBS.

Yoga is a traditional "mind-body-breath" discipline that includes yogic postures, structured breathing, and meditation. Several potential mechanisms for the effectiveness of yoga that have applicability to IBS have been proposed, including reducing the upregulated sympathetic activity and increasing the parasympathetic response. The investigator's recent review of the literature has identified four randomized controlled trials that examined traditional yoga practice as therapy for adult IBS patients. All trials found yoga as more effective compared to pharmacological treatment, and equally effective as dietary interventions or moderate-intensity walking. Both physical (IBS symptom severity, gastric motility, autonomic and somatic symptom scores, physical functioning) and mental (depression, anxiety, GI-specific anxiety, and QOL) improvements were seen. The current literature supports that yoga is effective, safe and it may target multiple mechanisms involved in the treatment of IBS symptoms as previously described. Although yoga is effective in managing IBS symptoms, further research is needed to determine the feasibility and effectiveness of yoga as a therapeutic option in clinical practice for patients with IBS, while also examining delivery strategies (face-to-face vs. online) to more optimally understand how to sequence therapeutic interventions and whether this improves initiation and adherence to the intervention.

Research Methods

Study Design. Superiority trial.

Recruitment. Potential participants will be identified through several avenues, including:

1. Gastroenterologists will screen IBS patients using the study eligibility criteria and following the patient's verbal consent, will share the patient's contact information with the study coordinator. Patients have previously given verbal permission at the clinic to their gastroenterologist to be asked to participate in research studies.
2. Self-referral through poster advertising in the GI clinics at Foothills and South Health Campus. In addition, the study will be advertised on the Faculty of Medicine TVs on the Foothills campus.
3. IMAGINE (Inflammation, Microbiome and Alimentation Gastro-intestinal and Neuropsychiatric Effects) cohort study at the University of Calgary: The IMAGINE study will send an initial email to all its IBS patients who have consented to be contacted for future studies. This email will explain the current study and connect interested participants with the study coordinator.
4. Self-referral through the Primary Care Networks (PCNs) in Calgary. Primary care physicians and/or dieticians (depending on the PCN clinic) will inform their IBS patients of the study and provide the patient with a brochure.
5. Through the use of a privately owned Facebook group called 'Low FODMAP Canadians', a group managed by two Canadian dieticians Lauren Renlund, MPH, RD and Audrey Inouye, RD. This group has over 2.1K members who have IBS.
6. Participants who indicated interest in this study in a previous survey (REB19-1456) and have given their consent to be contacted.

Screening. Consented participants will complete a mental health evaluation using the Patient Health Questionnaire-9 (PHQ-9). Individuals who score 20 points or higher on the PHQ-9 indicating sever depression will not be eligible to participate.

Intervention. Participants will be assigned randomly using the REDCap randomization module to either (a) a yoga intervention delivered online led by a yoga facilitator or (b) a advice only control group. The intervention group will receive a yoga program described below called Upa Yoga, including yoga Namaskar, Nadi Shuddi (alternate nostril breathing), mantra meditation, and breath watching. The intervention was developed in keeping with the ancient principles of Hatha Yoga and delivered by a trained yoga facilitator from the Isha Yoga Institute of Inner Sciences.

* Yoga Namaskar activates the lumbar region of the spine and strengthens the core muscles. This set of practices involves a series of 7 steps including stretching, squatting and structured breathing sequences which will take 10 minutes to complete.
* Nadi Shuddhi or alternate nostril breathing helps to bring balance between activity and emotion. Participants will sit in a cross-legged posture with the spine comfortably erect, eyes closed with the left hand laced in the middle of the lap, palm facing upwards, and the ring and index finger will be used to block one nostril while inhaling and exhaling through the other. This practice takes a minimum of 5 minutes to complete.
* Mantra Meditation. In the yogic culture, the entire existence is seen as a web of sounds or vibrations, for which the root sounds are "Aa, Oo, and Mm". These three sounds are referred to as universal sounds. This mantra, Aum, facilitates energy flow, and through vibratory mechanisms, has been demonstrated to create peace and harmony. This will be practiced for 3 minutes.
* Breath Watching. The science of breath watching in the yogic literature, employs the following principle: a certain thought, emotion or change in the physical body might change the breath flow. Similarly, the converse of principle is true, in that breathing in a structured manner can be used as a tool to bring positive changes to the practioners' mind, body and emotions. The practioners will assume a specific cross-legged physical posture, and practice breath watching as guided by the yoga instructor for 3-5-minutes.

Group 1: Yoga program. Participants will be asked to practice the yoga program daily at home and will be given access to the yoga videos hosted on the University of Calgary study website, as well as written program instructions, and frequently answered questions (Appendix A). A brief description of the video content will be provided to inform the participant of its content and length. Additional website content will include study information, study schedule, and contact information, as well as a pre-recorded educational session.

In addition to the daily program describe above, the facilitator-led intervention will be delivered online by a certified yoga facilitator using the Microsoft Teams platform. Participants in group of 3 to 5 will be collated to enhance effectiveness of the study processes. Our team has experience with this approach, as this strategy is currently used with previous yoga study. Yoga classes will be held once per week for 8 weeks, with the first session lasting approximately 1.5 hours and subsequent sessions up to 60 minutes. The total allocated time for the introductory session will include the class set-up, introductions, educational material (please see below), overview of practices, teaching of practices, practice corrections/enhancements, modifications, and practice expectations. Each follow-up class will include review from the previous week, questions and answers, individual corrections and/or modifications. For individual corrections, the yoga facilitator will ask the participant to do the practices and receive corrections, if needed.

Group 2. Advice-only control group. This group will receive general education on IBS, the mind and gut connection, and the role of mind-body therapies in the management of IBS.

Educational Material. The intervention group will receive educational material consisting of information on IBS, why yoga may improve IBS symptoms and quality of life, and self-compassion (Appendix B) during their first online session delivered by the study coordinator and yoga facilitator.

The study coordinator will orient each participant to the study, guide group 1 participants through expectations of the class, answer any study-related questions for the duration of the study. A study schedule will be provided to participants at the start of the study (Appendix C). The yoga facilitator will act as a point of contact to answer any questions related to the yoga program.

Practice Modifications. Intervention participants will receive modifications from the yoga facilitator for common challenges encountered by yoga practitioners to support optimal practices. Modifications will be provided in the online sessions.

Long-term follow-up. Yoga practice maintenance will be evaluated long-term. Intervention participants will be asked to report the average frequency (i.e., days per month) and length (i.e., minutes) of their yoga practices over the last 7 days at 6 months post intervention.

Feasibility outcomes. To determine the feasibility of each intervention, the following outcomes will be evaluated: recruitment and attrition rates, adherence, and satisfaction, and adverse event outcomes.

Sample size. 25 participants per group (mean difference of at least 83 points on the IBS-Symptom Severity Scale; ⍺=0.05, β=0.80, SD=103.8, ∆=83)35. Assuming a 20% attrition rate, we will aim to recruit 30 individuals per group.

Data Analysis. Descriptive analysis will summarize participant characteristics and feasibility outcomes. Independent sample t-tests will examine baseline differences between groups and chi-squared tests will examine proportion differences. Repeated measures ANOVA will examine the main effect of treatment condition and interactions of group assignment by time on effectiveness outcome measures. An alpha of 0.05 will be set a priori and used as a threshold for determining statistical significance. Analysis will be conducted using SPSS version 24.0.

For microbiome sequencing data quality control of raw FASTQ files will be performed, prior to ML analysis, to obtain high-quality non-host (HQNH) reads. Reads of sufficient quality will be mapped using MetaPhlAn2 and HUMAnN2 to obtain high-resolution taxonomic and functional abundance profiles that include read counts. Unsupervised learning strategy based on robust PCA will be used to explore the major variability in the data and to detect outliers. We will also perform KEGG annotations and functional diversity profiling and will use web-based tools to assign metagenomic results into different functional groups.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of IBS based on Rome IV criteria
* At least 18 years old
* Adequate understanding of English
* Ability to provide written informed consent
* No changes in IBS medication (including anti-depressants), diet, or physical activity levels for at least 8 weeks prior to starting the intervention

Exclusion Criteria:

* Major physical impairment that would prevent the individual from doing yoga
* Diagnosis of any major cognitive, psychological, or psychiatric disorder (diagnosed before or during the intervention) as identified by the treating physician/healthcare practitioner or screened by the study coordinator

Primary outcomes:
measure: IBS-Symptom Severity Scale
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: IBS-Quality of Life
timeFrame: Baseline and 8 weeks
measure: Generalized Anxiety Disorder
timeFrame: Baseline and 8 weeks
measure: Patient Health Questionnaire-9 (Depression)
timeFrame: Baseline and 8 weeks
measure: Perceived Stress Scale
timeFrame: Baseline and 8 weeks
measure: Modified Fatigue Impact Scale-21
timeFrame: Baseline and 8 weeks
measure: Patient Health Questionnaire-15 (Somatic Symptoms)
timeFrame: Baseline and 8 weeks
measure: COVID-19 Stress Scale
timeFrame: Baseline and 8 weeks
measure: Self-Compassion Scale-Short Form
timeFrame: Baseline and 8 weeks
measure: Recruitment rates
timeFrame: 8 weeks
measure: Attrition rates
timeFrame: 8 weeks
measure: Adherence to class attendance and home practice
timeFrame: 8 weeks
measure: Program preferences
timeFrame: Baseline
measure: Program satisfaction
timeFrame: 8 weeks
measure: Adverse event outcomes
timeFrame: 8 weeks
measure: Intention to practice yoga
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Maitreyi Raman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: D'Silva A, Marshall DA, Vallance J, Nasser Y, Rajagopalan V, MacKean G, Raman M. Meditation and yoga for irritable bowel syndrome: study protocol for a randomised clinical trial (MY-IBS study). BMJ Open. 2022 May 26;12(5):e059604. doi: 10.1136/bmjopen-2021-059604.