Mindfulness Training for Irritable Bowel Syndrome

Overseen By Janine Dutcher, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carnegie Mellon University

Must not be taking: Anxiolytics, Pain medications

Disqualifiers: Non-English, IBD, Pregnant, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of smartphone mindfulness and attention training programs in reducing stress and symptoms for people with Irritable Bowel Syndrome (IBS). Participants will use one of three programs: a combination of mindfulness and acceptance skills, a program focusing solely on mindfulness (also known as mindfulness training or mindfulness meditation), or a stress management program. The researchers aim to determine which method best reduces daily stress and improves IBS symptoms, and whether these approaches can alter the gut microbiome (the community of bacteria in the gut). People with IBS who have recently experienced stress might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative stress-reduction techniques that could enhance well-being.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking anxiolytic (anti-anxiety) or pain medications, you should not take them within 2 hours before the cold challenge sub-study session.

What prior data suggests that this mindfulness training is safe for individuals with IBS?

Past studies have shown that mindfulness training reduces symptoms of irritable bowel syndrome (IBS) without causing serious side effects. Participants often reported overall improvement and better bowel symptoms, indicating good tolerance of the treatment.

Similarly, digital health tools, such as smartphone-based training to help focus attention, have proven effective and safe for people with IBS. Research shows that these digital tools manage symptoms without major side effects.

Both mindfulness and smartphone-based methods appear to be safe options for those interested in trying new treatments for IBS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these mindfulness-based training treatments for irritable bowel syndrome (IBS) because they offer a unique approach compared to traditional medication or dietary changes. These treatments leverage smartphone technology to deliver mindfulness and attention training, which can be more accessible and convenient for users. By focusing on techniques like coping strategies and mindfulness meditation, they aim to help patients manage symptoms through stress reduction and improved attention regulation, potentially offering an alternative for those who prefer non-drug therapies. Additionally, the use of smartphone-based interventions can lead to broader reach and adherence, making it easier for people to integrate these practices into their daily lives.

What evidence suggests that this trial's treatments could be effective for IBS?

Research has shown that practicing mindfulness can greatly help with irritable bowel syndrome (IBS) symptoms. In this trial, participants will join different treatment arms to evaluate the effectiveness of mindfulness-based interventions. One study found that people who practiced mindfulness experienced less severe IBS symptoms. Another study suggested that mindfulness meditation can also reduce stomach pain and improve daily life for those with IBS. Mindfulness has been linked to less anxiety and depression, which often occur with IBS. Overall, these findings suggest that mindfulness could be a promising way to manage IBS. ^{1 3 6 7 8}

Who Is on the Research Team?

J. David Creswell, Ph.D.

Principal Investigator

Carnegie Mellon University

Emily K Lindsay, Ph.D.

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults with IBS who experience moderate to high psychological distress. Participants must be willing to use a smartphone for assessments, have an IBS diagnosis per Rome IV criteria, and not have started new IBS treatments recently. Exclusions include diagnosed gastrointestinal diseases or malignancies, certain health conditions (e.g., heart disease), non-English speakers, recent medical treatments requiring changes in care, pregnancy, and lack of COVID-19 vaccination.

Exclusion Criteria

I have high blood pressure.

I have a condition that causes me pain.

Is a patient of Dr. David Levinthal

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants complete a baseline survey assessment and learn how to complete EMA assessments on smartphones. They also provide a baseline stool sample for microbiome analysis.

1 week

1 visit (in-person)

Intervention

Participants undergo a 14-day smartphone-based training intervention, randomized to one of three programs: MA-MBI, MO-MBI, or CC. Daily lessons and homework practice are included.

2 weeks

Remote participation with phone check-ins on Days 3 and 9

Post-Treatment Assessment

Participants complete a week of EMA sampling and return to the lab for post-intervention assessment, including a second stool sample.

1 week

1 visit (in-person)

2-Month Follow-Up

Participants complete a final week of EMA sampling and a remote assessment, including a treatment program evaluation survey.

1 week

Remote assessment

What Are the Treatments Tested in This Trial?

Interventions

• Coping Condition
• Mindfulness and Attention Training
• Mindfulness training
• Smartphone Training for Attention Regulation

Trial Overview The study tests if a smartphone mindfulness program can reduce stress and IBS symptoms compared to two other groups: one with only attention training and another with stress management techniques. It includes daily life assessments via smartphones and explores potential changes in the gut microbiome due to the intervention.

How Is the Trial Designed?

Group I: Coping Condition (CC) Active Control 1 Intervention

14-day smartphone based training intervention focused on coping strategies consisting of a 5-minute introductory video, a 20-minute audio-guided lesson, plus daily life homework practice (3-10 minutes) each day.

Group II: Monitor & Accept (MA-MBI) Active Control 1 Intervention

14-day smartphone based mindfulness meditation attention monitoring and acceptance skills training intervention consisting of a 5-minute introductory video, a 20-minute audio-guided lesson, plus daily life homework practice (3-10 minutes) each day.

Group III: Monitor Only (MO-MBI) Active Control 1 Intervention

14-day smartphone based mindfulness meditation training intervention consisting of a 5-minute introductory video, a 20-minute audio-guided lesson, plus daily life homework practice (3-10 minutes) each day.

Who Is Running the Clinical Trial?

Carnegie Mellon University

Lead Sponsor

Trials

80

Recruited

540,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6502251/

Mindfulness Training Reduces the Severity of Irritable ... This randomized controlled trial demonstrated that mindfulness training has a substantial therapeutic effect on bowel symptom severity, improves health-related ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9658118/

Meditation and Irritable Bowel Syndrome, a Systematic ... The IBS-SSS was close to statistically significantly lower in the mindfulness group compared to the control group; the SMD of the IBS symptom ...

3. gastrojournal.org gastrojournal.org/article/S0016-5085(12)00391-5/fulltext

A Mindful Way Through IBS: Reducing Abdominal Pain ... This study suggests that mindfulness meditation can be an efficacious therapeutic modality to reduce both IBS and psychological symptoms and daily functioning.

4. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2025.1545033/full

Mindfulness is associated with the weight status, severity of ... According to scientific evidence, mindfulness has been effective in reducing anxiety and depression in patients with IBS (Mohamadi et al., 2015) ...

5. journal.ppcr.org journal.ppcr.org/index.php/ppcrjournal/article/download/297/277/5844

Mindfulness-Based Interventions for Irritable Bowel Syndrome Mindfulness- based therapy (MBT) 2 holds promise as this method has previously been shown to reduce anxiety and en- hance overall mental health.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11264829/

Comparison of the Effectiveness of Mindfulness-Based ... Mindfulness training reduces the severity of irritable bowel syndrome in women: results of a randomized controlled trial. Am J Gastroenterol. 2011;106(9): ...

7. researchgate.net researchgate.net/publication/251725380_Therapeutic_Impact_of_Mindfulness_Meditation_on_Irritable_Bowel_Syndrome_IBS_Results_of_a_Randomized_Controlled_Trial

(PDF) Therapeutic Impact of Mindfulness Meditation on ... Results suggest that MT exerts significant therapeutic effects on IBS symptoms by promoting nonreactivity to gut-focused anxiety and ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05719246?term=Short%20Bowel%20Syndrome&aggFilters=status:rec&limit=100&rank=20

Standardized Yoga & Meditation Program for Stress ... The aim of this study is to measure the impact of a brief , at-home, 6-week twice per week Standardized Yoga & Meditation Program for Stress Reduction program ...