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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Kearney, Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:
NCT00880256
First received: April 10, 2009
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

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 Intervention
Irritable Bowel Syndrome
Behavioral: mindfulness-based stress reduction

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data

Further study details as provided by Seattle Institute for Biomedical and Clinical Research:

Primary Outcome Measures:
  • IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Irritable Bowel Syndrome (IBS) Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 93
Study Start Date: September 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: mindfulness-based stress reduction

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.

  Eligibility

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

Inclusion Criteria:

  • All patient who enroll in a MBSR course

Exclusion Criteria:

  • Psychosis, borderline personality, active substance abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880256

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

No publications provided

Responsible Party: David Kearney, Staff Physician,, Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT00880256     History of Changes
Other Study ID Numbers: 0013
Study First Received: April 10, 2009
Results First Received: November 25, 2011
Last Updated: January 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Institute for Biomedical and Clinical Research:
irritable bowel
mindfulness
stress
meditation

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 15, 2014