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NCT Number: NCT04981925

Predictors of Pain Relief From Mindfulness-based Stress Reduction (MBSR) 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.

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Key information

Conditions

Chronic Pain Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Chronic Pain Connective Tissue Diseases Fibromyalgia Immune System Diseases Joint Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Rheumatic Diseases Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. PROMIS physical function 6b

    Time frame: 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 outcomes

  1. Change in PROMIS pain intensity, anxiety, pain interference

    Time frame: 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

  2. Change in PROMIS pain intensity, anxiety, pain interference

    Time frame: 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

  3. Change in Pain Catastrophizing Scale (PCS)

    Time frame: 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.

  4. Pain Catastrophizing Score; measured with Pain Catastrophizing Scale

    Time frame: 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

  5. Change in Chronic Pain Acceptance Questionnaire (CPAQ)-8

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2021
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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