Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data

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: NCT00880256
Recruitment Status : Completed
First Posted : April 13, 2009
Results First Posted : February 27, 2012
Last Update Posted : February 27, 2012
Information provided by (Responsible Party):
David Kearney, Seattle Institute for Biomedical and Clinical Research

Brief Summary:
Irritable bowel syndrome (IBS) is a very common, chronic disorder that significantly affects quality of life, and results in enormous expenditures each year in the United States. Therapy for IBS is generally unsatisfactory, and takes an additive approach whereby medications are prescribed according to each type of symptom the patient experiences. Accumulating evidence indicates that persons with IBS have a heightened perception of stress, and chronic stress has been shown to have a significant impact on IBS symptomatology. Mindfulness involves the ability to bring attention to the present moment without judgment; this ability is correlated with measures of mental health and decreased stress perception. The clinical literature suggests that mindfulness-based interventions may lead to improvement in many disorders including chronic pain, stress, anxiety, eating disorders and depressive relapse. The purpose of this study is to collect survey pilot data to determine whether an 8-week program of mindfulness-based stress reduction (MBSR) improves symptoms and quality of life for persons with IBS. Patients in the 8-week MBSR program are referred as part of their clinical care, and we seek approval only to collect survey data before and after the MBSR course. This study will evaluate whether there is sufficient evidence of efficacy to warrant a full clinical trial of MBSR.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Behavioral: mindfulness-based stress reduction Not Applicable

Detailed Description:
Aim 1: Apply measures of IBS symptom severity, depression and quality of life before and after the MBSR course, to assess whether there is evidence of benefit, and allow calculation of standardized effect sizes. Aim 2: Apply a validated measure of mindfulness before and after treatment. Aim 3: Explore the relationship between IBS symptoms, mindfulness score, and frequency of mindfulness practice.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data
Study Start Date : September 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Experimental: MBSR
Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
Behavioral: mindfulness-based stress reduction
An 8-week course in mindfulness training

Primary Outcome Measures :
  1. IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score) [ Time Frame: 6 months ]
    The Irritable Bowel Severity Scoring System (IBSSS) provides a measure of the severity of IBS. The measure consists of five questions, which assess severity of abdominal pain, number of days with abdominal pain in past 10 days, severity of abdominal distension, satisfaction with bowel habits, and impact of IBS on life in general. The score on each of the 5 questions ranges from 0 to 100, and the scores are summed with a range of total possible scores from 0 to 500. Higher scores reflect more severe IBS. Total score was used in the analyses.

Secondary Outcome Measures :
  1. Irritable Bowel Syndrome (IBS) Quality of Life [ Time Frame: 6 months ]
    The IBS-QOL is a disease specific Quality-of-Life Measure for IBS. IBS-QOL has been shown have a high level of content validity and to be responsive to change, and has been used in several outcome studies and clinical drug trials throughout the world. It consists of 34 questions that assess the influence of bowel habits on daily life. The response to each question is rated on a 5-point scale. A lower score indicates worse bowel-related quality of life. The summed total score is transformed to a 0-100 scale ranging from 0 (poor quality of life) to 100 (maximum quality of life).

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

Inclusion Criteria:

  • All patient who enroll in a MBSR course

Exclusion Criteria:

  • Psychosis, borderline personality, active substance abuse

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): NCT00880256

United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
Principal Investigator: David Kearney, MD VA Puget Sound Heatlh Care System

Responsible Party: David Kearney, Staff Physician,, Seattle Institute for Biomedical and Clinical Research Identifier: NCT00880256     History of Changes
Other Study ID Numbers: 0013
First Posted: April 13, 2009    Key Record Dates
Results First Posted: February 27, 2012
Last Update Posted: February 27, 2012
Last Verified: January 2012

Keywords provided by David Kearney, Seattle Institute for Biomedical and Clinical Research:
irritable bowel

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