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Mindfulness Training for Irritable Bowel Syndrome

N/A
Recruiting
Led By J. David Creswell, Ph.D.
Research Sponsored by Carnegie Mellon University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Rome IV IBS diagnosis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 1-week post-intervention and 2-month follow-up
Awards & highlights

Study Summary

This trial will compare the effectiveness of two different mindfulness-based interventions (MBIs) for treating irritable bowel syndrome (IBS), with a control group who will receive stress management training. The trial will use both clinician and patient assessed measures of IBS symptoms, as well asEcological Momentary Assessment to assess stress and symptoms in daily life.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
As this trial involves mindfulness-based interventions delivered through a smartphone app without medicinal products or invasive procedures, significant side effects are not anticipated. However, participants may experience discomfort from focusing on their condition during mindfulness practice.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with IBS according to Rome IV criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 1-week post-intervention and 2-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 1-week post-intervention and 2-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in IBS Symptom Severity
Change in Microbiome Biology
Change in Self-Reported IBS Quality of Life
+8 more
Secondary outcome measures
Change in Gastrointestinal Symptom-Specific Anxiety
Change in Self-Reported Depressive Symptomatology
Change in Self-Reported Distress Tolerance
+5 more
Other outcome measures
Change in Self-Reported Treatment Expectancies
Self-Reported Diet

Trial Design

3Treatment groups
Active Control
Group I: Monitor & Accept (MA-MBI)Active Control1 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 II: Coping Condition (CC)Active Control1 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 III: Monitor Only (MO-MBI)Active Control1 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.

Find a Location

Who is running the clinical trial?

Carnegie Mellon UniversityLead Sponsor
76 Previous Clinical Trials
539,605 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,346 Previous Clinical Trials
4,314,083 Total Patients Enrolled
23 Trials studying Irritable Bowel Syndrome
3,287 Patients Enrolled for Irritable Bowel Syndrome
National Institutes of Health (NIH)NIH
2,683 Previous Clinical Trials
6,930,533 Total Patients Enrolled
4 Trials studying Irritable Bowel Syndrome
347 Patients Enrolled for Irritable Bowel Syndrome

Media Library

Mindfulness and Attention Training Clinical Trial Eligibility Overview. Trial Name: NCT05083091 — N/A
Irritable Bowel Syndrome Research Study Groups: Monitor & Accept (MA-MBI), Coping Condition (CC), Monitor Only (MO-MBI)
Irritable Bowel Syndrome Clinical Trial 2023: Mindfulness and Attention Training Highlights & Side Effects. Trial Name: NCT05083091 — N/A
Mindfulness and Attention Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05083091 — N/A
Irritable Bowel Syndrome Patient Testimony for trial: Trial Name: NCT05083091 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any individuals being recruited for this trial at the moment?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which was first announced on February 10th 2022, is still recruiting participants. Currently the study needs to enroll 325 patients from 1 site."

Answered by AI

What results is this research endeavor attempting to acquire?

"The primary objective of this research, which will be assessed over a post-intervention period, is to gauge Pain Tolerance following Cold Pressor Task. Additionally, the study seeks to measure Change in Self-Reported Loneliness with the UCLA Loneliness Scale (ranging from 20 - 80), Change in Self-Reported Mindfulness using The Five Facet Mindfulness Questionnaire (24 items) and finally Change in Self-Reported Perceived Stress through The 10 Item Perception Scale (0 - 40)."

Answered by AI

What is the cap on participants in this medical study?

"Affirmative. According to clinicaltrials.gov's records, this medical trial is currently seeking volunteers; it was initially posted on February 10th 2022 and last updated on August 16th 2022. A total of 325 people are needed for the study at one site."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
What state do they live in?
California
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have tried 7 drugs and also a lot of supplements that have not shown any improvement to my condition what so ever.
PatientReceived no prior treatments
Recent research and studies
~132 spots leftby Sep 2025