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

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Behavioral: Mindfulness training; Behavioral: Psycho-educational support group for women with IBS

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina At Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
IBS-S	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Visceral Sensitivity Index	3 months
Work Productivity and Activity Impairment for IBS (WPAI:IBS)	3 months
Recent Physical Symptoms Questionnaire (RPSQ)	3 months
Brief Symptom Inventory (BSI)	3 months
State Trait-Anger Expression Inventory (STAXI)	3 months
Coping Strategies Questionnaire (CSQ)	3 months
IBS QOL	3 months
Daily Symptom Diary	Daily x 10 weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Susan A Gaylord, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Gaylord SA, Whitehead WE, Coble RS, Faurot KR, Palsson OS, Garland EL, Frey W, Mann JD. Mindfulness for irritable bowel syndrome: protocol development for a controlled clinical trial. BMC Complement Altern Med. 2009 Jul 28;9:24. doi: 10.1186/1472-6882-9-24.

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: May 15, 2008
• First Submitted That Met QC Criteria: May 15, 2008
• First Posted (Estimate): May 20, 2008

Study Record Updates

• Last Update Posted (Estimate): November 18, 2011
• Last Update Submitted That Met QC Criteria: November 17, 2011
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: IBS, functional gastrointestinal disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: R21AT003619-02 (U.S. NIH Grant/Contract)