Effects of Mindfulness-Based Stress Reduction on Knee Osteoarthritis (MBSR on KOA)
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| ClinicalTrials.gov Identifier: NCT03527849 |
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Recruitment Status :
Completed
First Posted : May 17, 2018
Last Update Posted : December 22, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Knee Osteoarthritis | Behavioral: Mindfulness-Based Stress Reduction Behavioral: Health Enhancement Program | Not Applicable |
The current study is aiming to compare two stress reduction programs in order to see if stress reduction may lead to less pain due to knee osteoarthritis (OA). There are two stress reduction programs being compared, Mindfulness-Based Stress Reduction (MBSR) and a Health Enhancement Program (HEP). MBSR is a secular program that trains mindfulness meditation for stress reduction and to increase emotional regulation skills. It is defined as "paying attention in a particular way, on purpose, in the present moment, and non-judgmentally." Mindfulness refers to a set of meditation practices that develop a wide array of cognitive skills which include: attention regulation, response inhibition, and emotion regulation. HEP is an educational course intended to teach participants about their disease, factors influencing disease progression, nutrition, physical activity including walking and stretching, and functional movement. Key difference between these two is MBSR includes the mindfulness component, and MBSR will be taught either in-person or online. HEP will only consist of an in-person course.
The online MBSR course will be offered through: http://www.breathworks-mindfulness.org.uk/mindfulness-for-health. The investigators propose to use an active control training, the Health Enhancement Program (HEP), an intervention designed to isolate mindfulness as a testable active ingredient.
The duration of an individual subject's participation in the study will be at least 10 weeks starting from the screening visit all the way to the follow-up visit.
The in-person MBSR course consists of 8 weekly classes plus one all-day class between Weeks 6 and 7, and is sequential. Depending on when a participant is consented, they may have to wait until a new 8-week course is available in order to begin. The HEP course also consists of 8 weekly classes and will start when a group of 7-10 participants have been assigned to the HEP intervention. The online MBSR course is designed to last 8 weeks and can be started at any time.
Since initiation of the in-person MBSR or HEP courses will depend upon when subjects are enrolled, it is not possible to provide the maximum length of time for a subject's participation. However long the subject's participation, they are only expected to complete 2 in-clinic visits and 8 weeks of class (plus 1 all-day class for MBSR).
Weekly classes are 2.5 hours with the one-day retreat lasting from 10am to 5pm on a weekend day. The online MBSR course is roughly 20 minutes per day for 6-7 days of the week for 8 weeks.
HEP and MBSR are structurally equivalent, both using a group format that meets once a week for 2.5 hours for 8 weeks, plus home participation, but the in-person MBSR includes an "all day" component after week 6. The content of the HEP intervention meets the following criteria: (1) class activities match MBSR activities as closely as possible, (2) activities represent valid, active, therapeutic ingredients in their own right, and (3) these ingredients do not include mindfulness.
All participants will be assigned into one of the three courses by the Principal Investigator. Prior to the initial class of the participants' respective course, blood will be collected, and within two weeks after the final class, participants will return to collect the second set of blood samples. These collections prior and after treatment will be at the clinic, visits to the clinic may last from 1 to 2 hours.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 9 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Masking Description: | The study will be structured as a parallel-group controlled trial. The Principal Investigator will assign participants into the three groups. This will allow for equalization of distribution of participants across the three groups. It will not be possible to blind the participants to which arm of the trial they are participating in, as the content or lack thereof of their activities will be obvious to them. For results analysis, collaborators at the UCD West Coast Metabolomics Center will be blinded to the treatment of the respective samples, thus eliminating potential bias during analysis. |
| Primary Purpose: | Basic Science |
| Official Title: | The Effect of Mindfulness-Based Stress Reduction on Pain and Function in Persons With Knee Osteoarthritis |
| Actual Study Start Date : | January 30, 2018 |
| Actual Primary Completion Date : | September 30, 2020 |
| Actual Study Completion Date : | September 30, 2020 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: In-Person MBSR Course |
Behavioral: Mindfulness-Based Stress Reduction
The intervention will be an MBSR course.
Other Name: Mindfulness |
| Experimental: Online MBSR Course |
Behavioral: Mindfulness-Based Stress Reduction
The intervention will be an MBSR course.
Other Name: Mindfulness |
| Active Comparator: In-Person HEP |
Behavioral: Health Enhancement Program
Propose to use an active control training, the Health Enhancement Program (HEP), an intervention designed to isolate mindfulness as a testable active ingredient. HEP and MBSR are structurally equivalent in that they share the same amount of in- and out-of class work time. The content of the HEP intervention meet the following criteria: (1) class activities match MBSR activities as closely as possible, (2) activities represent valid, active, therapeutic ingredients in their own right, and (3) these ingredients do not include mindfulness.
Other Name: HEP |
- Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) [ Time Frame: At First Clinical Visit (Baseline Week 1), During Treatment (Once per week for 8 Weeks), at Second Clinical Visit (Post-Treatment Week 10), this will be done through the participant's duration in the study on average lasting 10 weeks. ]A joint specific questionnaire used to measure the condition of patients with knee osteoarthritis, pain, stiffness, and physical functioning of the inflicted joints. Each question is answered by selecting a box from a scale of 0-10 (0=No Pain, 10=Extreme Pain). The investigators plan on collecting a baseline measurement prior to the treatment, weekly measurements through the treatment (1 per week for 8 weeks), and another after the treatment is completed to track changes.
- Change in Emotion Regulation Questionnaire (ERQ) [ Time Frame: At First Clinical Visit (Baseline Week 1), Mid-Treatment (Week 5), at Second Clinical Visit (Post-TreatmentWeek 10), this will be done through the participant's duration in the study on average lasting 10 weeks. ]
A self-reported questionnaire that identifies the habitual use of two emotional regulation strategies, between cognitive reappraisal and expressive suppression.
Answered in a scale ranging from 1-7 (1=strongly disagree, 4=neutral, 7=strongly agree). Answered prior to receiving treatment, half-way through treatment completion, and post-treatment.
- Change in 5 Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: At First Clinical Visit (Baseline Week 1), Mid-Treatment (Week 5), at Second Clinical Visit (Post-Treatment Week 10), this will be done through the participant's duration in the study on average lasting 10 weeks. ]A self-reported questionnaire intended to measure the five factors to conceptually be involved with mindfulness. It is answered using a 1-5 scale (1=never or very rarely true, 2=rarely true, 3=sometimes true, 4=often true, 5=very often or always true). Answered prior to receiving treatment, half-way through treatment completion, and post-treatment.
- Change in Pain Catastrophizing Scale (PCS) [ Time Frame: At First Clinical Visit (Baseline Week 1), Mid-Treatment (Week 5), at Second Clinical Visit (Post-Treatment Week 10), this will be done through the participant's duration in the study on average lasting 10 weeks. ]
A self-reported questionnaire used to quantify an individual's pain experience through a series of questions asking about the individual's feelings and thoughts about when they are in pain.
Answered in a scale of 0-4 (0=not at all, 1=to a slight degree, 2=to a moderate degree, 3=to a great degree, 4=all the time). Answered prior to receiving treatment, half-way through treatment completion, and post-treatment.
- Change in Plasma Cortisol Levels [ Time Frame: At First Clinical Visit (Baseline Week 1) and at Second Clinical Visit (Post-Treatment Week 10) ]Cortisol is a hormone the human body releases in times of stress. Because the investigators are aiming to reduce stress the investigative team will be collecting blood (4mL RED-top Vacutainer tube) prior to beginning treatment (respective stress reduction course) and after the course is completed to assess if there were changes in cortisol levels. Cortisol levels will be obtained in micrograms per deciliter (ug/dL).
- Change in Cytokine Plasma Levels [ Time Frame: At First Clinical Visit (Baseline Week 1) and at Second Clinical Visit (Post-Treatment Week 10) ]Cytokines are markers secreted by cells that help direct cell function during an immune response. The investigators will collect blood and process serum for analysis to measure and track changes in cytokine levels responsible for inflammation. The blood will be collected at the first clinical visit and the second clinical visit. The measurements will be interpreted in picograms per milliliter (pg/mL).
- Change in Oxylipin Plasma Levels [ Time Frame: At First Clinical Visit (Baseline Week 1) and at Second Clinical Visit (Post-Treatment Week 10) ]Oxylipin inflammation markers will be measured from plasma processed from collected blood at the first and second clinical visits. There are usually 84 markers and are positively detected and quantified even in healthy individuals using 150uL of plasma. The investigative team expects there to be higher concentrations of these markers in elderly subjects with OA pain, furthermore, the investigators expect differences in concentrations of these markers for the different treatments. These values will be addressed in nanomolar (nM).
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| Ages Eligible for Study: | 50 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Positive "Frequent Knee Pain" question
- Radiographically confirmed knee OA (Kellgren/Lawrence ≥ 2)
Exclusion Criteria:
- Scheduled to have knee replacement surgery within 6 months from enrollment
- Rheumatoid arthritis or another inflammatory arthritis
- Known avascular necrosis (death of bone due to lack of blood supply)
- Failure to comply with run-in procedures: poor attendance or non-compliant with completing the activity
- Major psychiatric illness, cognitive impairment or alcohol/substance abuse
- Non-English speaking
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527849
| United States, California | |
| University of California, Davis Medical Center | |
| Davis, California, United States, 95817 | |
| Principal Investigator: | Barton L. Wise | UC Davis School of Medicine | |
| Principal Investigator: | Philippe Goldin | UC Davis Betty Irene School of Nursing |
Documents provided by University of California, Davis:
Other Publications:
| Responsible Party: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT03527849 |
| Other Study ID Numbers: |
1180036 |
| First Posted: | May 17, 2018 Key Record Dates |
| Last Update Posted: | December 22, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | The investigators plan on making unidentifiable participant data for all primary and secondary outcome measures available. No information linking the data to the individual participant will be released, but measurements, averages, and statistical analysis will be made available. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
| Time Frame: | Data will become available 6 months after study completion. |
| Access Criteria: | Data access requests will be reviewed by Principle Investigators. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Osteoarthritis Knee Osteoarthritis Knee Pain |
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Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |