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

NCT00880256 | Completed Results

• 1 other identifier: 0013
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel; mindfulness; stress; meditation

Outcome Measures

Primary Outcomes (1)

• IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score)

  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.

  6 months

Secondary Outcomes (1)

• Irritable Bowel Syndrome (IBS) Quality of Life

  6 months

Study Arms (1)

MBSR

EXPERIMENTAL

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

Interventions

mindfulness-based stress reduction BEHAVIORAL

An 8-week course in mindfulness training

MBSR

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patient who enroll in a MBSR course

You may not qualify if:

• Psychosis, borderline personality, active substance abuse

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. David Kearney
• Organization: VA Puget Sound Health Care System

david.kearney@va.gov

206-764-2285

Study Officials

• David Kearney, MD

  VA Puget Sound Heatlh Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician,

Study Record Dates

• First Submitted: April 10, 2009
• First Posted: April 13, 2009
• Study Start: September 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 27, 2012
• Results First Posted: February 27, 2012

Record last verified: 2012-01

Locations

US (1)