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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mindfulness-based stress reduction
Sponsored by
Seattle Institute for Biomedical and Clinical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring irritable bowel, mindfulness, stress, meditation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All patient who enroll in a MBSR course

Exclusion Criteria:

  • Psychosis, borderline personality, active substance abuse

Sites / Locations

  • VA Puget Sound Health Care System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MBSR

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Irritable Bowel Syndrome (IBS) Quality of Life
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).

Full Information

First Posted
April 10, 2009
Last Updated
January 20, 2012
Sponsor
Seattle Institute for Biomedical and Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00880256
Brief Title
Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data
Official Title
Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Institute for Biomedical and Clinical Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
irritable bowel, mindfulness, stress, meditation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBSR
Arm Type
Experimental
Arm Description
Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
Intervention Type
Behavioral
Intervention Name(s)
mindfulness-based stress reduction
Intervention Description
An 8-week course in mindfulness training
Primary Outcome Measure Information:
Title
IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Irritable Bowel Syndrome (IBS) Quality of Life
Description
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).
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patient who enroll in a MBSR course Exclusion Criteria: Psychosis, borderline personality, active substance abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kearney, MD
Organizational Affiliation
VA Puget Sound Heatlh Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

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

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