Predictors of Pain Relief From Mindfulness-based Stress Reduction (MBSR) in Multiple Forms of Chronic Pain Patients
Study Details
Study Description
Brief Summary
The overall objective of this study is to better understand how Mindfulness-based Stress Reduction (MBSR) is the most helpful in terms of management of chronic pain symptoms.
The studies hypothesis is that an Interventional Response Phenotyping study (light phenotyping) can identify individuals with different underlying mechanisms for their pain who thus respond differentially to evidence-based interventions for chronic pain disorders.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Participants enrolled in this study will receive 8 weeks of MBSR therapy and complete surveys at various time points pre-treatment - post treatment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MBSR treatment
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Behavioral: MBSR treatment
Participants will complete pre-treatment surveys followed by 8-weekly 2-hour group sessions and one 6-hour "retreat" (may take place virtually or in-person). Participants will also be asked to practice daily formal mindfulness at home using assigned audio recordings of 30-45 minute guided mindfulness exercises. Participants will complete surveys during treatment as well as after treatment and then at 2 months follow-up.
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Outcome Measures
Primary Outcome Measures
- PROMIS physical function 6b [8 weeks (after MSBR)]
Physical Function 6b questionnaire will assess self-reported capability with 6 qualitatively scaled questions ranked on a 5-point scale, from "without any difficulty" to "unable to do" or "not at all" to "cannot do." The minimum raw summed score is 6 and the maximum score is 30. Lower scores suggest better outcomes.
Secondary Outcome Measures
- Change in PROMIS pain intensity, anxiety, pain interference [Baseline (pre-treatment), 8 weeks]
Change from baseline in pain interference (QoL), measured by PROMIS Pain Interference 6a. Measure of the amount of interference pain causes in life; range 6-30; higher is worse
- Change in PROMIS pain intensity, anxiety, pain interference [Baseline (pre-treatment), 8 and 12 weeks]
Change from baseline in pain interference (QoL), measured by PROMIS Pain Interference 6a. Measure of the amount of interference pain causes in life; range 6-30; higher is worse
- Change in Pain Catastrophizing Scale (PCS) [Baseline (pre-treatment), 8 and 12 weeks]
The PCS is a 13-item questionnaire that inquires about thoughts and feelings a patient experiences when in pain. Responses are recorded on a 5-point Likert scale ("not at all" to "all the time"). A total score is yielded ranging from 0-52. Higher score is associated with worse outcome.
- Pain Catastrophizing Score; measured with Pain Catastrophizing Scale [8 weeks (after MSBR)]
The PCS is a 13-item questionnaire that inquires about thoughts and feelings a patient experiences when in pain. Responses are recorded on a 5-point Likert scale ("not at all" to "all the time"). A total score is yielded ranging from 0-52. Higher score is associated with worse outcome
- Change in Chronic Pain Acceptance Questionnaire (CPAQ)-8 [Baseline, 8 weeks (after MSBR)]
CPAQ-8 is an 8-item questionnaire with a score range 0-48 with higher scores indicating better status. Change score is computed by subtracting baseline CPAQ-8 score from score at time of reassessment. Improvement is indicated by change scores with positive values.
Eligibility Criteria
Criteria
Inclusion Criteria:
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A form of chronic pain disorder other than chronic lower back pain (cLBP) - examples include chronic pain associated with rheumatoid arthritis, fibromyalgia, neuropathy, neuralgia, etc.
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Forms of cLBP not allowed in Back Pain Consortium Research Program Study Mechanistic Research Center(sacroiliitis or a spondyloarthropathy, e.g. ankylosing spondylitis).
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Definition of chronic pain suggested by the 2014 NIH Pain Consortium, i.e. pain present at least six months, and present more than half of those days
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Individuals must have a pain interference score of ≥60 on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference. The normal population mean for pain interference is 50.
Exclusion Criteria:
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Unable to speak and write English
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Visual or hearing difficulties that would preclude participation
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Chronic pain from migraine headaches.
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Chronic pain from cancer.
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Severe psychiatric disorders that in the opinion of the investigative team would interfere with participation in the study. This includes any active suicidal ideations or history of suicide attempts, because of safety issues concerning administering duloxetine to such individuals
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Current severe substance use disorder (mild or moderate substance use that is being managed / treated will be accepted)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
Investigators
- Principal Investigator: Todd Favorite, Ph.D., University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00187535