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NCT00680693 · ClinicalTrials.gov registry record · NA
Mindfulness vs. Support Groups for Irritable Bowel Syndrome
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 75
- Enrollment target
NCT00680693 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 75 participants.
The verdict
NCT00680693, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
Study Summary
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
Interventions
- BEHAVIORAL Mindfulness training
- BEHAVIORAL Psycho-educational support group for women with IBS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2006-10 |
| Est. Completion | 2010-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00680693
The ClinicalTrials.gov registry entry for NCT00680693 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mindfulness training is the first listed.
NCT00680693 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00680693 about?
NCT00680693 is a clinical study titled "Mindfulness vs. Support Groups 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 burd...
What is the current status of trial NCT00680693?
This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2006-10. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00680693?
The interventions under investigation include: Mindfulness training (BEHAVIORAL), Psycho-educational support group for women with IBS (BEHAVIORAL).
Who is sponsoring clinical trial NCT00680693?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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