Mindfulness Training for Irritable Bowel Syndrome

Recruiting in Palo Alto (17 mi)

Overseen byJ. David Creswell, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Carnegie Mellon University

No Placebo Group

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.

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

I have high blood pressure.

I have a condition that causes me pain.

Is a patient of Dr. David Levinthal

+22 more

Participant Groups

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.

3Treatment groups

Active Control

Group I: 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 II: 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 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.