Back to resultsPredictors of Pain Relief From Mindfulness-based Stress Reduction (MBSR) in Multiple Forms of Chronic Pain Patients
Primary Purpose
Chronic Pain Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MBSR treatment
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Pain Syndrome focused on measuring chronic pain, rheumatoid arthritis, fibromyalgia, neuropathy, neuralgia, pain
Eligibility Criteria
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.
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MBSR treatment
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04981925
Brief Title
Predictors of Pain Relief From Mindfulness-based Stress Reduction (MBSR) in Multiple Forms of Chronic Pain Patients
Official Title
Predictors of Pain Relief From Mindfulness-based Stress Reduction in Multiple Forms of Chronic Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain Syndrome
Keywords
chronic pain, rheumatoid arthritis, fibromyalgia, neuropathy, neuralgia, pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MBSR treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
MBSR treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
PROMIS physical function 6b
Description
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.
Time Frame
8 weeks (after MSBR)
Secondary Outcome Measure Information:
Title
Change in PROMIS pain intensity, anxiety, pain interference
Description
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
Time Frame
Baseline (pre-treatment), 8 weeks
Title
Change in PROMIS pain intensity, anxiety, pain interference
Description
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
Time Frame
Baseline (pre-treatment), 8 and 12 weeks
Title
Change in Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
Baseline (pre-treatment), 8 and 12 weeks
Title
Pain Catastrophizing Score; measured with Pain Catastrophizing Scale
Description
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
Time Frame
8 weeks (after MSBR)
Title
Change in Chronic Pain Acceptance Questionnaire (CPAQ)-8
Description
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.
Time Frame
Baseline, 8 weeks (after MSBR)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Banner
Phone
734-736-5226
Email
eledward@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Todd Favorite, Ph.D.
Phone
734-764-3471
Email
tfavor@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Favorite, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Banner
Phone
734-736-5226
Email
eledward@med.umich.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Predictors of Pain Relief From Mindfulness-based Stress Reduction (MBSR) in Multiple Forms of Chronic Pain Patients
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