An interventional study of mindfulness-based stress reduction in Irritable Bowel Syndrome, sponsored by Seattle Institute for Biomedical and Clinical Research. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-27.
Sponsored by Seattle Institute for Biomedical and Clinical Research · Not applicable, Interventional, and Treatment
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.
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 93 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Seattle Institute for Biomedical and Clinical Research is the lead sponsor of 48 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
Behavioral: mindfulness-based stress reduction
An 8-week course in mindfulness training
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.
Time frame: 6 months
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).
Time frame: 6 months
During a 17-month period, we enrolled 93 patients who were referred or self-referred themselves to the Mindfulness-Based Stress Reduction (MBSR) program at VA Puget Sound.
| Milestone | MBSR |
|---|---|
| Started | 93 |
| Completed | 65 |
| Not completed | 28 |
| Withdrew: Lost to follow-up | 28 |
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.
| units on a scale | Mindfulness-Based Stress Reduction (MBSR) |
|---|---|
| IBS (IBS) symptoms | 256.9 ± 90.6 |
| Irritable Bowel Syndrome Quality of LIfe (QOL) | 84.4 ± 20.6 |
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).
| units on a scale | Mindfulness-Based Stress Reduction (MBSR) |
|---|---|
| Irritable Bowel Syndrome (IBS) Quality of Life | 224.3 ± 96.3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MBSR | — | 0/93 (0%) | 0/93 (0%) |
| Age Continuous(years) | MBSR |
|---|---|
| Mean | 51 ± 10.6 |
| Sex: Female, Male(Participants) | MBSR |
|---|---|
| Female | 24 |
| Male | 69 |
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Seattle Institute for Biomedical and Clinical Research