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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain Syndrome
• Intervention / Treatment: Behavioral: MBSR treatment

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 Type: Interventional
• Enrollment (Actual): 381
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MBSR treatment

Behavioral: MBSR treatment; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Todd Favorite, Ph.D., University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): February 27, 2025

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: chronic pain; rheumatoid arthritis; pain; fibromyalgia; neuralgia; neuropathy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: HUM00187535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No