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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04981925
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Michigan
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Todd Favorite, Ph.D.
Principal Investigator Affiliation University of Michigan
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Pain Syndrome
Additional Details

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

  • - post treatment.

Arms & Interventions

Arms

Experimental: MBSR treatment

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Elizabeth Banner

[email protected]

734-736-5226