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BMC Complementary Medicine and Therapies
Published in: BMC Complementary Medicine and Therapies 1/2009

Open Access 01-12-2009 | Study protocol

Mindfulness for irritable bowel syndrome: protocol development for a controlled clinical trial

Authors: Susan A Gaylord, William E Whitehead, Rebecca S Coble, Keturah R Faurot, Olafur S Palsson, Eric L Garland, William Frey, John Douglas Mann

Published in: BMC Complementary Medicine and Therapies | Issue 1/2009

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Abstract

Background

Irritable bowel syndrome (IBS), a functional bowel disorder with symptoms of abdominal pain and disturbed defecation experienced by 10% of U.S. adults, results in significant disability, impaired quality of life, and health-care burden. Conventional medical care focusing on pharmacological approaches, diet, and lifestyle management has been partially effective in controlling symptoms. Behavioral treatments, such as cognitive-behavioral therapy and hypnosis, are promising. This paper describes an on-going feasibility study to assess the efficacy of mindfulness training, a behavioral treatment involving directing and sustaining attention to present-moment experience, for the treatment of IBS.

Methods/Design

The study design involves randomization of adult women with IBS according to Rome II criteria, to either an eight-week mindfulness training group (based on a Mindfulness-based Stress Reduction [MBSR] format) or a previously validated IBS social-support group as an attention-control condition. The primary hypothesis is that, compared to Support Group participants, those in the Mindfulness Program will demonstrate significant improvement in IBS symptoms as measured by the IBS Symptom Severity Scale [1].

Discussion

214 individuals have been screened for eligibility, of whom 148 were eligible for the study. Of those, 87 were enrolled, with 21 withdrawing after having given consent. 66 have completed or are in the process of completing the interventions. It is feasible to undertake a rigorous randomized clinical trial of mindfulness training for people with IBS, using a standardized MBSR protocol adapted for those experiencing IBS, compared to a control social-support group previously utilized in IBS studies.

Trial Registration

Clinical Trials.gov Identifier: NCT00680693
Appendix
Available only for authorised users
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Metadata
Title
Mindfulness for irritable bowel syndrome: protocol development for a controlled clinical trial
Authors
Susan A Gaylord
William E Whitehead
Rebecca S Coble
Keturah R Faurot
Olafur S Palsson
Eric L Garland
William Frey
John Douglas Mann
Publication date
01-12-2009
Publisher
BioMed Central
Published in
BMC Complementary Medicine and Therapies / Issue 1/2009
Electronic ISSN: 2662-7671
DOI
https://doi.org/10.1186/1472-6882-9-24

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