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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susan Gaylord, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00680693
First received: May 15, 2008
Last updated: November 17, 2011
Last verified: February 2010
  Purpose

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 Intervention
Irritable Bowel Syndrome
Behavioral: Mindfulness training
Behavioral: Psycho-educational support group for women with IBS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness for Irritable Bowel Syndrome

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • IBS-S [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visceral Sensitivity Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment for IBS (WPAI:IBS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Recent Physical Symptoms Questionnaire (RPSQ) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Brief Symptom Inventory (BSI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • State Trait-Anger Expression Inventory (STAXI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Coping Strategies Questionnaire (CSQ) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • IBS QOL [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Daily Symptom Diary [ Time Frame: Daily x 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 75
Study Start Date: October 2006
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680693

Locations
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
Investigators
Principal Investigator: Susan A Gaylord, PhD University of North Carolina, Chapel Hill
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Susan Gaylord, Assistant Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00680693     History of Changes
Other Study ID Numbers: R21 AT003619-02, R21AT003619-02
Study First Received: May 15, 2008
Last Updated: November 17, 2011
Health Authority: United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
IBS, functional gastrointestinal disease

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014