Neuroimaging Biomarkers of Mind-Body Treatment Response in Chronic Visceral Pain
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Irritable Bowel Syndrome
- Sponsor
- University of California, Los Angeles
- Enrollment
- 119
- Locations
- 1
- Primary Endpoint
- Validate Optimal Biomarker candidates
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to use functional magnetic resonance imaging (fMRI) to evaluate brain resting state networks, responses to abdominal stimuli and the effect of MBSR Training on these measures. The goal of this study is to identify biomarkers of IBS and assess the responsiveness these biomarkers after MBSR Training. A biomarker, or biological marker, is in general a substance or measure used as an indicator of a biological state. It is a characteristic that is measured and evaluated as an indicator of normal biological processes, disease processes, or responses to a therapeutic intervention, in this case MBSR.
Detailed Description
Irritable bowel syndrome (IBS) is the most common chronic visceral pain disorder ranking among the most common of all persistent pain disorders with prevalence rates of 8-12% of the population.3 Diagnostic criteria for IBS include persistent abdominal pain and/or discomfort associated with changes in bowel habit. In the majority of patients, symptoms of other co-morbid pain conditions, such as epigastric pain (functional dyspepsia), pelvic pain (IC/PBS) and musculoskeletal pain (FM) are reported. Estimates are that \>50% of the U.S. workforce experiences some type of pain and 13% lose productive work time due to pain over a 2 week period, leading to over 60 billion dollars per year in lost productivity costs.4 There are no generally agreed upon biomarkers for IBS, and diagnoses are exclusively based on subjective symptom criteria. As with most of the persistent pain disorders, IBS patients and their providers have increasingly embraced a biopsychosocial model incorporating psychological and social factors along with physiologic factors, and this forms the basis for integrative treatment approaches. This multimodal approach often incorporates Mind-Body treatments, and there is a growing literature showing clinical efficacy in IBS for interventions incorporating such Mind-Body approaches as meditation, hypnosis, yoga and cognitive therapy.5 However, there is little understanding of the physiological mechanisms underlying mind-body therapies, and for this reason optimization of the treatments for specific individuals and populations is difficult. In this project we aim to use neuroimaging based biomarkers of IBS to examine which of these physiological measures show changes specific to a mind-body treatment with previously documented efficacy, Mindfulness Based Stress Reduction Training or MBSR. MBSR was chosen as a target treatment for several reasons: Recent clinical trial data suggests there is efficacy in improving IBS symptoms with MBSR, it has demonstrated prior success with other chronic pain conditions and there is considerable literature on meditation associated brain changes. The primary Objective is to validate optimal biomarker candidates by assessment of treatment responsiveness in IBS patients following Mindfulness Based Stress Reduction (MBSR). The secondary objectives are to determine the generality of optimal biomarkers from Aim 1 and 2 and look at factors such as sex, age, co-morbid pain or mood symptoms, and/or baseline disease severity as moderators of the performance of candidate biomarkers. Also, exploratory analyses will be performed to assess the effect of an 8 week MBSR training on measures of disease cognition, quality of life and mood defined by pre and post test scores on the behavioral measures listed in the study methods.
Investigators
Kirsten Tillisch, MD
Principal Investigator
University of California, Los Angeles
Eligibility Criteria
Inclusion Criteria
- •Patients must meet the Rome III criteria for IBS and lack red flag symptoms, such as weight loss, bloody stool, and fever. In the setting of clinical uncertainty on the part of the examining gastroenterologist, laboratory testing or prior medical records may be requested.
- •Upper gastrointestinal symptoms, ie. dyspepsia or heartburn, are acceptable as long as IBS is their most bothersome symptom complex.
- •Subject cannot have completed structured training in MBSR or other mindfulness or meditation.
- •Subject cannot be currently practicing MBSR.
- •A minimal severity score of 75 on the IBS-SSS at screening will be required to ensure at least mild-moderate symptoms at baseline.
- •Literate in English
- •Ambulatory without a need for assistive devices.
- •Able to participate in the sitting and mild yoga positions required for the MBSR course.
- •Right handed due to importance of laterality in brain imaging analysis
- •Not pregnant, nursing or postpartum.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Validate Optimal Biomarker candidates
Time Frame: After MBSR training (8 weeks).
To validate optimal brain biomarker candidates by assessment of treatment responsiveness in IBS patients following and 8 week course in Mindfulness Based Stress Reduction (MBSR).
Secondary Outcomes
- Specificity, generality and moderation of biomarker response to MBSR treatment.(Post MBSR training at 3 month follow up.)