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Mindfulness Training for Irritable Bowel Syndrome
N/A
Recruiting
Led By J. David Creswell, Ph.D.
Research Sponsored by Carnegie Mellon University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
High blood pressure
Have a history of diagnosed IBD or gastrointestinal malignancies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 1-week post-intervention and 2-month follow-up
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
As this trial involves mindfulness-based interventions delivered through a smartphone app without medicinal products or invasive procedures, significant side effects are not anticipated. However, participants may experience discomfort from focusing on their condition during mindfulness practice.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have high blood pressure.
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I have been diagnosed with inflammatory bowel disease or a cancer in my digestive system.
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I have a history of heart or cardiovascular disease.
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I have Reynaud's disease.
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I have had seizures in the past.
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I have sickle cell disease or carry the trait.
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I have asthma.
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I have open cuts or sores on both of my hands.
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I have a condition that affects my blood circulation.
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I have a brain blood vessel condition.
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I have had a stroke or heart attack recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 1-week post-intervention and 2-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 1-week post-intervention and 2-month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in IBS Symptom Severity
Change in Microbiome Biology
Change in Self-Reported IBS Quality of Life
+8 moreSecondary study objectives
Change in Gastrointestinal Symptom-Specific Anxiety
Change in Self-Reported Depressive Symptomatology
Change in Self-Reported Distress Tolerance
+5 moreOther study objectives
Change in Self-Reported Treatment Expectancies
Self-Reported Diet
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Find a Location
Who is running the clinical trial?
Carnegie Mellon UniversityLead Sponsor
77 Previous Clinical Trials
539,535 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,444 Previous Clinical Trials
4,330,856 Total Patients Enrolled
28 Trials studying Irritable Bowel Syndrome
3,583 Patients Enrolled for Irritable Bowel Syndrome
National Institutes of Health (NIH)NIH
2,811 Previous Clinical Trials
8,160,878 Total Patients Enrolled
5 Trials studying Irritable Bowel Syndrome
370 Patients Enrolled for Irritable Bowel Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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 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.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.
Research Study Groups:
This trial has the following groups:- Group 1: Coping Condition (CC)
- Group 2: Monitor & Accept (MA-MBI)
- Group 3: Monitor Only (MO-MBI)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Irritable Bowel Syndrome Patient Testimony for trial: Trial Name: NCT05083091 — N/A
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