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Mindfulness vs. Support Groups for Irritable Bowel Syndrome (M-IBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00680693
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : November 18, 2011
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Susan Gaylord, University of North Carolina, Chapel Hill

Brief 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 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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Behavioral: Mindfulness training Behavioral: Psycho-educational support group for women with IBS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness for Irritable Bowel Syndrome
Study Start Date : October 2006
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: 1
Mindfulness-based stress management 8-week program
Behavioral: Mindfulness training
8 weekly 2-hour classes

Active Comparator: 2
Psycho-educational support group for women with IBS
Behavioral: Psycho-educational support group for women with IBS
8 weekly 2-hour meetings

Primary Outcome Measures :
  1. IBS-S [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Visceral Sensitivity Index [ Time Frame: 3 months ]
  2. Work Productivity and Activity Impairment for IBS (WPAI:IBS) [ Time Frame: 3 months ]
  3. Recent Physical Symptoms Questionnaire (RPSQ) [ Time Frame: 3 months ]
  4. Brief Symptom Inventory (BSI) [ Time Frame: 3 months ]
  5. State Trait-Anger Expression Inventory (STAXI) [ Time Frame: 3 months ]
  6. Coping Strategies Questionnaire (CSQ) [ Time Frame: 3 months ]
  7. IBS QOL [ Time Frame: 3 months ]
  8. Daily Symptom Diary [ Time Frame: Daily x 10 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age or older, female, English-speaking, confirmed IBS meeting Rome II criteria with a minimum duration of symptoms of six months and under the care of a physician for IBS; able to provide informed consent; willing and able to document IBS symptoms and use of medications, as well as complete the assessment instruments. Subjects must be willing to attend and participate in 8 weekly Mindfulness Program or Support Group sessions.

Exclusion Criteria:

  • Evidence of severe neuropsychological impairment or psychosis, significant depression, anxiety, a history of an inpatient admission for psychiatric disorder within the past two years; pregnancy or anticipated pregnancy; undergoing active treatment for a major medical illness such as malignancy, diabetes, autoimmune or immune deficiency disorder; a history of inflammatory bowel disease, gastrointestinal malignancy, active liver or pancreatic disease including diabetes, uncontrolled lactose intolerance, celiac disease, a history of abdominal trauma or surgery, cognitive impairment that prevents understanding or responding to study questions; prior history of mindfulness meditation training. Given the highly verbal nature of the interventions, otherwise eligible patients who do not speak or write English will be excluded from this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00680693

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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Susan A Gaylord, PhD University of North Carolina, Chapel Hill
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Susan Gaylord, Assistant Professor, University of North Carolina, Chapel Hill Identifier: NCT00680693    
Other Study ID Numbers: R21AT003619-02 ( U.S. NIH Grant/Contract )
R21AT003619-02 ( U.S. NIH Grant/Contract )
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: November 18, 2011
Last Verified: February 2010
Keywords provided by Susan Gaylord, University of North Carolina, Chapel Hill:
IBS, functional gastrointestinal disease
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases