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

NCT ID: NCT00880256

Last Updated: 2012-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-10-31

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.

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MBSR

Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.

Group Type: EXPERIMENTAL

mindfulness-based stress reduction

Intervention Type: BEHAVIORAL

An 8-week course in mindfulness training

Interventions

mindfulness-based stress reduction

An 8-week course in mindfulness training

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• All patient who enroll in a MBSR course

Exclusion Criteria

• Psychosis, borderline personality, active substance abuse

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Seattle Institute for Biomedical and Clinical Research

OTHER

Sponsor Role: lead

Responsible Party

David Kearney

Staff Physician,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Kearney, MD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Heatlh Care System

Locations

VA Puget Sound Health Care System

Seattle, Washington, United States

Countries

United States

Other Identifiers

0013

Identifier Type: -

Identifier Source: org_study_id