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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00880256
• Other study ID #: 0013
• Status: Completed
• Phase: N/A
• First received: April 10, 2009
• Last updated: January 20, 2012
• Start date: September 2008
• Est. completion date: October 2010

Study information

• Verified date: January 2012
• Source: Seattle Institute for Biomedical and Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patient who enroll in a MBSR course

Exclusion Criteria:

• Psychosis, borderline personality, active substance abuse

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Behavioral:
• mindfulness-based stress reduction
An 8-week course in mindfulness training

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Institute for Biomedical and Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Secondary	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).	6 months	No