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Mindfulness Training for Irritable Bowel Syndrome
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have high blood pressure.I have a condition that causes me pain.I have been diagnosed with inflammatory bowel disease or a cancer in my digestive system.I have a history of heart or cardiovascular disease.I have Reynaud's disease.I was diagnosed with a new health or mental condition needing treatment in the last 3 months.I have had seizures in the past.I have sickle cell disease or carry the trait.I have asthma.I have been diagnosed with IBS according to Rome IV criteria.I have open cuts or sores on both of my hands.I have a condition that affects my blood circulation.I have not taken anxiety or pain medication in the last 2 hours.I have not taken anxiety or pain medication within 2 hours before the lab session.I felt sick or had symptoms like a cold, stomachache, or fever before the session started.I have not started any new IBS treatments in the last 4 weeks.I have a brain blood vessel condition.I have had a stroke or heart attack recently.You have been feeling mentally stressed or anxious for the past two weeks, as indicated by your answers on a survey called the Patient Health Questionnaire-4.You are willing to answer questions about your bowel movements and complete all study requirements, including using a smartphone for assessments.You have been feeling very emotionally stressed or upset for the past two weeks.I have been diagnosed with IBS according to Rome IV criteria.You are willing to participate in all aspects of the study, including being randomly assigned to a treatment group.
- Group 1: Monitor & Accept (MA-MBI)
- Group 2: Coping Condition (CC)
- Group 3: Monitor Only (MO-MBI)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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)."
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."
Who else is applying?
What portion of applicants met pre-screening criteria?
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How many prior treatments have patients received?
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