Neuroimaging and Biomarkers in Chronic Visceral Pain
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|ClinicalTrials.gov Identifier: NCT01602575|
Recruitment Status : Completed
First Posted : May 21, 2012
Last Update Posted : May 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Behavioral: Mindfulness based Stress Reduction Training (MBSR)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neuroimaging Biomarkers of Mind-Body Treatment Response in Chronic Visceral Pain|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||March 20, 2016|
|Actual Study Completion Date :||March 20, 2018|
Experimental: mindfulness treatment
Mindfulness based stress reduction is the intervention in this single arm trial
Behavioral: Mindfulness based Stress Reduction Training (MBSR)
8 (2 hr) classes weekly of MBSR and required homework of MBSR practice approximately 30 minutes per day.
- 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).
- Specificity, generality and moderation of biomarker response to MBSR treatment. [ Time Frame: Post MBSR training at 3 month follow up. ]
Specificity of biomarker response to MBSR measured by changes in selected biomarker candidates correlation w/improvement in mindfulness at end of treatment & 3-month f/u.
Determine generality of optimal biomarkers via examination of factors such as sex, age, co-morbid pain,mood, and/or baseline disease severity, as moderators of biomarker performance.
Moderation of biomarker performance by symptoms: Disease severity, duration, and comorbid symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602575
|United States, California|
|Oppenheimer Center for Neurobiology of Stress|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Kirsten Tillisch, MD||University of California, Los Angeles|