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

Chronic Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04981925
• Other study ID #: HUM00187535
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: July 2025

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: Elizabeth Banner
• Phone: 734-736-5226
• Email: eledward[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)