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

NCT04981925 | Completed

• 1 other identifier: HUM00187535
• Study Type: interventional
• Target: 381
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain Syndrome

Keywords

chronic pain; rheumatoid arthritis; fibromyalgia; neuropathy; neuralgia; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in PROMIS pain intensity, anxiety, pain interference

  Baseline (pre-treatment), 8 weeks

• Change in PROMIS pain intensity, anxiety, pain interference

  Baseline (pre-treatment), 8 and 12 weeks

• Change in Pain Catastrophizing Scale (PCS)

  Baseline (pre-treatment), 8 and 12 weeks

• Pain Catastrophizing Score; measured with Pain Catastrophizing Scale

  8 weeks (after MSBR)

• Change in Chronic Pain Acceptance Questionnaire (CPAQ)-8

  Baseline, 8 weeks (after MSBR)

Study Arms (1)

MBSR treatment

EXPERIMENTAL

Behavioral: MBSR treatment

Interventions

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.

MBSR treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18+
• Any form of self-reported chronic pain (except cancer related pain)

You may not qualify if:

• Unable to speak and write English
• Visual or hearing difficulties that would preclude participation
• Chronic pain from cancer.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Chronic Pain; Arthritis, Rheumatoid; Fibromyalgia; Neuralgia; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Peripheral Nervous System Diseases

Study Officials

• Todd Favorite, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Psychological Clinic, Clinical Associate Professor of Mary A Rackham Institute, Graduate School and Associate Professor of Psychiatry

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 29, 2021
• Study Start: August 1, 2021
• Primary Completion: January 30, 2025
• Study Completion: February 27, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)