Predictors of Pain Relief From Mindfulness-based Stress Reduction (MBSR) in Multiple Forms of Chronic Pain Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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Participants enrolled in this study will receive 8 weeks of MBSR therapy and complete surveys at various time points pre-treatment - post treatment.

Official Title
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Predictors of Pain Relief From Mindfulness-based Stress Reduction in Multiple Forms of Chronic Pain Patients

Conditions
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Chronic Pain Syndrome

Intervention / Treatment
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* Behavioral: MBSR treatment


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for MBSR Study Ages 18+ Any form of self-reported chronic pain (except cancer related pain) Exclusion criteria for MBSR study Unable to speak and write English Visual or hearing difficulties that would preclude participation Chronic pain from cancer.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR treatment<br> | Behavioral: MBSR treatment<br>* Participants will complete pre-treatment surveys followed by 8-weekly 2-hour group sessions and one 4-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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS physical function 6b | 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. | 8 weeks (after MSBR) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PROMIS pain intensity, anxiety, pain interference | 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 | Baseline (pre-treatment), 8 weeks | 
| Change in PROMIS pain intensity, anxiety, pain interference | 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 | Baseline (pre-treatment), 8 and 12 weeks | 
| Change in Pain Catastrophizing Scale (PCS) | 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. | Baseline (pre-treatment), 8 and 12 weeks | 
| Pain Catastrophizing Score; measured with Pain Catastrophizing Scale | 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 | 8 weeks (after MSBR) | 
| Change in Chronic Pain Acceptance Questionnaire (CPAQ)-8 | 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. | Baseline, 8 weeks (after MSBR) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, rheumatoid arthritis, fibromyalgia, neuropathy, neuralgia, pain