Smartphone Training for Attention Regulation for IBS

Completed · Not applicable

Conditions studied: Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID: NCT05083091
Run by: Carnegie Mellon University
People needed: 359
Starts: 2022-03-01
Expected to finish: 2025-02-14
Last updated by the study team: 2025-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Rome IV IBS diagnosis
Indicate moderate to high levels of psychological distress over the past two weeks (composite score >=4 on the Patient Health Questionnaire-4)
Willingness to provide assessments of bowel symptoms and complete study measures (including smartphone assessments)
Willingness/availability to be randomized and participate in all study activities

You may not qualify if…

Non-English speaking
Report a new diagnosis of a (non-acute) medical or psychiatric condition requiring treatment within the last 3 months
Have a history of diagnosed IBD or gastrointestinal malignancies.
Begun any new treatments for IBS in the four weeks prior to baseline
Currently pregnant
Had a colonoscopy within 2 weeks of enrolling in the study or within the first 4 weeks of study procedures
CGI Interview Only: Is a patient of Dr. David Levinthal
Cold Challenge Sub-study. Exclusion criteria: an existing pain condition, Reynaud's disease, history of heart/cardiovascular disease, high blood pressure, recent injuries, circulatory disorders, current or past frostbite, open cuts, or sores in both hands, a history of seizures, asthma, sickle cell disease or trait, cerebrovascular disease, a recent stroke or heart attack, or anxiolytic medication (e.g., Ativan, Xanax) or pain medication (e.g., aspirin) taken in the 2 hours prior to the study, pregnant or might be pregnant, and/or have a tendency/history of fainting after vaccines, shots, and/or blood draws. Participants will be excluded if they have taken anxiolytic medication (e.g., Ativan, Xanax) or pain medication (e.g., aspirin) taken in the 2 hours prior to the lab session. Participants who report viral illness (e.g., cold) and/or negative physical health symptoms (e.g., stomachache, nausea, fever, dehydration, hunger, sleep deprivation) before the start of the session will also be excluded.
As they will be visiting our laboratory on campus, participants will now be required to show proof of COVID-19 vaccination to participate in the study. Participants must also show proof of a booster shot, if they do not have one, they will be asked to wear a mask at in-person sessions to participate. Moving forward, we will continue to follow CMU COVID protocols.

Where it is running

Carnegie Mellon University — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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