Chronic Pain SyndromeNCT04981925
Predictors of Pain Relief From Mindfulness-based Stress Reduction (MBSR) in Multiple Forms of Chronic Pain Patients
A study testing MBSR treatment in people with Chronic Pain Syndrome, run by University of Michigan at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain Syndrome
- What is being tested?
- MBSR treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 27 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18+
- Any form of self-reported chronic pain (except cancer related pain)
Who cannot join
- Unable to speak and write English
- Visual or hearing difficulties that would preclude participation
- Chronic pain from cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain Syndrome
- Being tested
- MBSR treatment
- Keywords
- chronic pain, rheumatoid arthritis, fibromyalgia, neuropathy, neuralgia, pain
- Medical subject headings
- Chronic Pain, Arthritis, Rheumatoid, Fibromyalgia, Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSR treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MBSR treatment | Experimental | Not described Receives: Behavioral: MBSR treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks (after MSBR)
Secondary outcomes (5)
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, 8 weeks (after MSBR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Aug 2021
- Primary completion30 Jan 2025
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Favorite, University of Michigan
- Investigators
- Todd Favorite, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981925
- Sponsor's protocol ID
- HUM00187535
- Status last verified
- Aug 2025
- First submitted
- 19 Jul 2021
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Pain Relief From Mindfulness-based Stress Reduction in Multiple Forms of Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT04981925
- Acronym / sponsor ID
- HUM00187535
- Conditions
- Chronic Pain Syndrome
- Keywords
- chronic pain, rheumatoid arthritis, fibromyalgia, neuropathy, neuralgia, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBSR treatment | Experimental | Behavioral: MBSR treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18+
- Any form of self-reported chronic pain (except cancer related pain)
Key exclusion criteria (3 listed)
- Unable to speak and write English
- Visual or hearing difficulties that would preclude participation
- Chronic pain from cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBSR treatmentParticipants 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. | Behavioural | MBSR treatment |
Primary outcome
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.
5 secondary outcomes
Change in PROMIS pain intensity, anxiety, pain interference
Time frame: Baseline (pre-treatment), 8 weeks
Change in PROMIS pain intensity, anxiety, pain interference
Time frame: Baseline (pre-treatment), 8 and 12 weeks
Change in Pain Catastrophizing Scale (PCS)
Time frame: Baseline (pre-treatment), 8 and 12 weeks
Pain Catastrophizing Score; measured with Pain Catastrophizing Scale
Time frame: 8 weeks (after MSBR)
Change in Chronic Pain Acceptance Questionnaire (CPAQ)-8
Time frame: Baseline, 8 weeks (after MSBR)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Favorite, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR treatment in people with Chronic Pain Syndrome, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS physical function 6b (time frame: 8 weeks (after MSBR)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.