Mindfulness Training for Irritable Bowel Syndrome
Trial Summary
What is the purpose of this trial?
In the largest and most well-controlled randomized control trial of mindfulness-based interventions (MBIs) training in irritable bowel syndrome (IBS) to-date (N=360), the investigators will evaluate whether a smartphone MBI program (with attention monitoring and acceptance skills training; Monitor+Accept, MA-MBI) reduces daily life stress and IBS symptoms at post-treatment and two-month follow-up, relative to a matched MBI program with acceptance skills training removed (training in attention monitoring skills only; Monitor Only, MO-MBI) or to an active stress management training control group (Coping Control, CC). Participants will not only provide clinician and patient assessed measures of IBS symptoms at the three time points, but they will also provide sensitive experience sampling assessments (using Ecological Momentary Assessment) of their stress and symptoms in daily life at each time point. Finally, as an exploratory aim, participants will provide stool samples at baseline and post-intervention to provide the first ever test of whether MBIs can alter the gut microbiome in IBS. We will also conduct a sub-study that will include completion of a cold-water challenge performance task to test individuals' distress tolerance.
Research Team
J. David Creswell, Ph.D.
Principal Investigator
Carnegie Mellon University
Emily K Lindsay, Ph.D.
Principal Investigator
University of Pittsburgh
Eligibility Criteria
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
Post-Treatment Assessment
Participants complete a week of EMA sampling and return to the lab for post-intervention assessment, including a second stool sample.
2-Month Follow-Up
Participants complete a final week of EMA sampling and a remote assessment, including a treatment program evaluation survey.
Treatment Details
Interventions
- Coping Condition
- Mindfulness and Attention Training
- Mindfulness training
- Smartphone Training for Attention Regulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Carnegie Mellon University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
National Institutes of Health (NIH)
Collaborator