- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00880256
Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data
January 20, 2012 updated by: David Kearney, Seattle Institute for Biomedical and Clinical Research
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
93
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98108
- VA Puget Sound Health Care System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- All patient who enroll in a MBSR course
Exclusion Criteria:
- Psychosis, borderline personality, active substance abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
An 8-week course in mindfulness training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David Kearney, MD, VA Puget Sound Heatlh Care System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
April 10, 2009
First Submitted That Met QC Criteria
April 10, 2009
First Posted (Estimate)
April 13, 2009
Study Record Updates
Last Update Posted (Estimate)
February 27, 2012
Last Update Submitted That Met QC Criteria
January 20, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Irritable Bowel Syndrome
-
ProgenaBiomeRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
-
ClasadoCR2O B.V.RecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome - Constipation | Irritable Bowel Syndrome - Diarrhoea | Irritable Bowel Syndrome - MixedBelgium, Netherlands, United Kingdom
-
Istanbul Medipol University HospitalTepecik Training and Research Hospital; Bozyaka Training and Research Hospital and other collaboratorsRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedTurkey
-
Federal Stare Budgetary Scientific Institution,...I.M. Sechenov First Moscow State Medical University; RML INVEST, Torkhovsky...CompletedIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedRussian Federation
-
University of California, Los AngelesCompletedIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Mixed Bowel HabitsUnited States
-
University of ViennaCompleted
-
Thomayer University HospitalCharles University, Czech RepublicActive, not recruitingIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome MixedCzechia
-
Shahid Beheshti University of Medical SciencesCompletedIrritable Bowel DiseaseIran, Islamic Republic of
-
Universidad Autonoma de ChihuahuaNot yet recruitingIrritable Bowel Syndrome | Constipation-predominant Irritable Bowel Syndrome | Diarrhea- Irritable Bowel Syndrome
-
Vasily IsakovRussian Science Foundation; Azbuka vkusa; Federal Research Centre of Nutrition...CompletedIrritable Bowel Syndrome With Constipation | Constipation-predominant Irritable Bowel SyndromeRussian Federation
Clinical Trials on mindfulness-based stress reduction
-
Duke UniversityNational Center for Complementary and Integrative Health (NCCIH)CompletedCardiovascular Diseases | Inflammation | Stress, Psychological | SleepUnited States
-
University of California, San FranciscoCompletedDementia | Frontotemporal Dementia | Frontotemporal Lobar Degeneration | Caregiver Stress Syndrome | Caregiver Burnout | Dementia Frontal | Mindfulness Based Stress ReductionUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruiting
-
Oregon Health and Science UniversityPortland VA Medical CenterCompleted
-
Chang Gung Memorial HospitalRecruitingLate Life DepressionTaiwan
-
Schneider Children's Medical Center, IsraelCompletedInflammatory Bowel DiseasesIsrael
-
Clemson UniversityUniversity of California, Los Angeles; Prisma Health-UpstateCompletedQuality of Life | Diabetes | Stress | Health Behavior | Pre-DiabetesUnited States
-
University of AarhusVU University of AmsterdamUnknown
-
Johns Hopkins UniversityCompleted
-
Spaulding Rehabilitation HospitalCompletedStress | Brain Injury | Traumatic Brain InjuryUnited States