Clinical Trials Directory

Trials / Completed

CompletedNCT00880256

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
93 (actual)
Sponsor
Seattle Institute for Biomedical and Clinical Research · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALmindfulness-based stress reductionAn 8-week course in mindfulness training

Timeline

Start date
2008-09-01
Primary completion
2010-10-01
Completion
2010-10-01
First posted
2009-04-13
Last updated
2012-02-27
Results posted
2012-02-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00880256. Inclusion in this directory is not an endorsement.