N/A
N=93
Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data
Irritable Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00880256 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcome: Primary: IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score) — 256.9; 84.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mindfulness-based stress reduction (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score) |
256.9; 84.4 | — |
| SECONDARY Irritable Bowel Syndrome (IBS) Quality of Life |
224.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- All patient who enroll in a MBSR course
Exclusion Criteria
- Psychosis, borderline personality, active substance abuse
Data sourced from ClinicalTrials.gov (NCT00880256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.