Mindfulness-Based Stress Reduction for IBD

(MBSRforIBD Trial)

Overseen By Jennifer Jones, MD, FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Pediatric participants

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how mindfulness-based stress reduction (MBSR) might assist people with Inflammatory Bowel Disease (IBD) by reducing stress and improving mental and physical health. Participants will either join an 8-week MBSR program or watch an educational video on stress reduction. The goal is to determine if MBSR can more effectively reduce stress and inflammation compared to standard care. Individuals with a known diagnosis of mildly to moderately active IBD may be suitable for this study. As an unphased trial, this study offers a unique opportunity to explore innovative stress reduction techniques that could enhance overall well-being.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.

What prior data suggests that the Mindfulness-Based Stress Reduction program is safe for people with IBD?

Studies have shown that mindfulness-based stress reduction (MBSR) can help people with inflammatory bowel disease (IBD) by reducing anxiety and depression and improving overall quality of life, at least in the short term. This conclusion is based on research involving adults with IBD who participated in similar mindfulness programs.

Research indicates that participants generally find MBSR easy to handle. Many people consider these programs acceptable and effective, especially when conducted online. Reports of serious side effects from MBSR are absent. Instead, many participants report feeling better both mentally and physically after joining these programs.

These findings suggest that MBSR could be a safe option for people with IBD, offering a way to manage stress and improve well-being without major side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindfulness-Based Stress Reduction (MBSR) program for Inflammatory Bowel Disease (IBD) because it offers a non-pharmaceutical approach to managing symptoms. Unlike standard treatments that often involve medications like anti-inflammatories or immunosuppressants, MBSR uses mindfulness techniques to help reduce stress, which can be a significant trigger for IBD flare-ups. This program is delivered virtually, making it accessible for people who might have difficulty attending in-person sessions. Additionally, the emphasis on mindfulness and stress management provides a holistic option that could complement existing medical treatments, potentially leading to improved overall well-being for individuals with IBD.

What evidence suggests that the Mindfulness-Based Stress Reduction program might be an effective treatment for IBD?

Research has shown that mindfulness-based stress reduction (MBSR) can benefit people with inflammatory bowel disease (IBD). Studies indicate that MBSR improves quality of life by reducing stress, which often links to gut issues like inflammation. One study found that MBSR might reduce flare-ups in individuals with ulcerative colitis, a type of IBD. Other research suggests that mindfulness practices can complement regular IBD treatments, potentially easing symptoms and enhancing overall well-being. In this trial, participants in the MBSR group will engage in an 8-week mindfulness-based stress reduction course. These findings suggest that MBSR might effectively manage stress related to IBD and improve health outcomes. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with Inflammatory Bowel Disease (IBD), including Ulcerative Colitis, who are interested in exploring how mindfulness techniques can impact their condition. Specific eligibility criteria details were not provided.

Inclusion Criteria

I am 18 years old or older.

My IBD is active but not severe.

Exclusion Criteria

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week Mindfulness-Based Stress Reduction (MBSR) program, attending weekly 2.5-hour sessions and one full-day weekend session.

8 weeks

8 weekly sessions (virtual) plus one full-day session

Follow-up

Participants are monitored for psychological distress, self-efficacy, and other health outcomes post-treatment.

6 months

2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness-based Stress Reduction Program

Trial Overview The study compares the effects of an 8-week Mindfulness-based Stress Reduction (MBSR) program to standard care on mental and physical health in IBD patients. It aims to see if MBSR reduces distress and inflammation better than usual treatment.

How Is the Trial Designed?

Group I: MBSR group Experimental Treatment 1 Intervention

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.

Group II: Active Control Active Control 1 Intervention

Will be asked to watch an educational video on stress reduction

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07266883

A Mindfulness-based Stress Reduction Program for IBD This study will assess how effective the MBSR program is compared to standard care at reducing distress and signs of stress and inflammation in ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36990003/

The effectiveness of mindfulness-based interventions in ... MBI's appear to be effective in improving several IBD outcomes, they may be a useful adjuvant therapy in wholistic IBD care, with further trials warranted.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022399923000892

Review article The effectiveness of mindfulness-based ... Given that MBI's appear to be effective in improving several IBD outcomes, they may be a useful adjuvant therapy in wholistic IBD care, with ...

4. academic.oup.com academic.oup.com/ibdjournal/article/31/11/3021/8200868

Group-Delivered Mindfulness-Based Cognitive Therapy to ... Mindfulness-Based Cognitive Therapy can be considered a valuable addition to the limited effective psychosocial interventions set for IBD ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4059005/

A Randomized Controlled Trial of Mindfulness Based ... A randomized controlled trial of mindfulness based stress reduction to prevent flare-up in patients with inactive ulcerative colitis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11319758/

Mindfulness-Based Interventions on Psychological ... Mindfulness-based intervention training can improve anxiety, depression, and quality of life in patients with inflammatory bowel disease in the short term.

7. formative.jmir.org formative.jmir.org/2024/1/e53550

Integrating Virtual Mindfulness-Based Stress Reduction Into ... This study aims to evaluate the feasibility, acceptability, and effectiveness of virtual mindfulness-based stress reduction (v-MBSR) for adults with IBD.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04646785?term=NCT04646785&rank=1

Mindfulness-based Cognitive Therapy for Patients With ... Considering the limited availability of psychosocial interventions for IBD, this study aims to investigate MBCT as an adjunctive treatment to treatment as ...

9. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-07426-7

Impact of anxiety, depression and online mindfulness on IBD ... Study 2: A randomized parallel design tested the Online MINdfulness-based stress reduction with Daily EXercise (MINDEX) program vs an active ...