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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.
Participants enrolled in this study will receive 8 weeks of MBSR therapy and complete surveys at various time points pre-treatment - post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBSR treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBSR treatment | Behavioral | 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. |
| 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) |
| 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 |
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Inclusion criteria for MBSR Study
Exclusion criteria for MBSR study
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| Name | Affiliation | Role |
|---|---|---|
| Todd Favorite, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001172 | Arthritis, Rheumatoid |
| D005356 | Fibromyalgia |
| D009437 | Neuralgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
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|
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) |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |