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Mindfulness Training for Irritable Bowel Syndrome

N/A

Waitlist Available

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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 1-week post-intervention and 2-month follow-up for reporting.

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 more

Secondary study objectives

Change in Gastrointestinal Symptom-Specific Anxiety

Change in Self-Reported Depressive Symptomatology

Change in Self-Reported Distress Tolerance

+5 more

Other 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.

0 / 11Eligibility criteria met