Irritable Bowel Syndrome Clinical Trial
Official title:
Mindfulness for Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) is a common and disabling functional disorder characterized
by significant abdominal discomfort and disturbed defecation. It affects over 10% of U.S.
adults (14% women, 8% men), resulting in major disability, impaired quality of life, and a
significant health-care burden. Conventional management of IBS is only partially effective
in some patients and includes use of medications, behavioral modification, dietary
approaches, and lifestyle changes such as exercise and stress reduction. Although behavioral
treatments such as cognitive behavioral therapy and hypnosis have been among the most
effective treatments, they are costly to deliver.
Mindfulness meditation, a complementary/alternative medicine (CAM) therapy taught in groups,
is a unique self-regulatory, mind-body approach in which practitioners learn to attend to
present-moment experiences, letting go of fixation on negative emotions and thoughts of past
and future. It has been found to be effective in reducing chronic pain and stress and in
ameliorating disorders with similarities to IBS, including fibromyalgia, headache, and
depression.
The overall goals of this exploratory, pilot study of women with IBS are to compare
mindfulness meditation training to a patient support group (a previously validated control
condition) in a small, randomized controlled clinical trial, in order to assess the
feasibility of a larger, definitive trial. Specific aims are to evaluate primary and
secondary outcome measures, to assess expectancy of benefit and scales measuring mindfulness
(process measures), and to identify barriers to conducting such a trial in our setting.
Sixty women meeting Rome II diagnostic criteria for IBS will be randomly assigned to one of
two treatments - mindfulness meditation training or a support group - and will undergo 8
weekly group sessions plus a single day-long session. The primary outcome measure is
improvement on the validated Irritable Bowel Symptom Severity Scale from pretreatment to the
end of treatment, with follow-up at 3, 6, and 12 months. Additional variables address
alternative endpoints (e.g., Adequate Relief of IBS symptoms, disease specific quality of
life) and mechanism of treatment effects (e.g., coping scales, psychological symptoms,
Visceral Sensitivity Scale). The multidisciplinary research team includes physicians,
psychologists, and educators.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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