Smartphone Training for Attention Regulation for IBS

Launched by CARNEGIE MELLON UNIVERSITY · Oct 18, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a smartphone-based program designed to help people with Irritable Bowel Syndrome (IBS) manage their symptoms and stress through mindfulness techniques. Researchers want to find out if this program, which focuses on both monitoring attention and accepting feelings, can improve daily stress and IBS symptoms compared to a similar program that only teaches attention skills or a different stress management program. The study will also explore how these mindfulness practices might change the gut bacteria in people with IBS.

To participate, you need to have a diagnosis of IBS and be experiencing moderate to high levels of stress. Participants should be open to sharing details about their bowel symptoms and completing various assessments using a smartphone. If you qualify and join the study, you'll be asked to provide feedback on your symptoms at multiple points over the course of the study and may also take part in a sub-study involving a cold-water challenge to test your stress response. It's important to note that participants must show proof of COVID-19 vaccination to take part in any in-person sessions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.