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

Seattle Institute for Biomedical and Clinical Research

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Behavioral: mindfulness-based stress reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT00880256

0013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patient who enroll in a MBSR course

Exclusion criteria

• Psychosis, borderline personality, active substance abuse

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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93 participants in 1 patient group

MBSR

Experimental group

Description:

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

Treatment:

Behavioral: mindfulness-based stress reduction