Effects of Mindfulness-Based Stress Reduction on Knee Osteoarthritis
NCT ID: NCT03527849
Last Updated: 2020-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
9 participants
INTERVENTIONAL
2018-01-30
2020-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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In-Person MBSR Course
Mindfulness-Based Stress Reduction
The intervention will be an MBSR course.
Online MBSR Course
Mindfulness-Based Stress Reduction
The intervention will be an MBSR course.
In-Person HEP
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.
Interventions
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Mindfulness-Based Stress Reduction
The intervention will be an MBSR course.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Radiographically confirmed knee OA (Kellgren/Lawrence ≥ 2)
Exclusion Criteria
* 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
50 Years
80 Years
ALL
No
Sponsors
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University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Barton L. Wise
Role: PRINCIPAL_INVESTIGATOR
UC Davis School of Medicine
Philippe Goldin
Role: PRINCIPAL_INVESTIGATOR
UC Davis Betty Irene School of Nursing
Locations
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University of California, Davis Medical Center
Davis, California, United States
Countries
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References
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Kabat-Zinn J, University of Massachusetts Medical Center/Worcester. Stress Reduction Clinic. Full catastrophe living: using the wisdom of your body and mind to face stress, pain, and illness. New York, N.Y.:Delacorte Press; 1990.
Trelle S, Reichenbach S, Wandel S, Hildebrand P, Tschannen B, Villiger PM, Egger M, Juni P. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis. BMJ. 2011 Jan 11;342:c7086. doi: 10.1136/bmj.c7086.
Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs. N Engl J Med. 1999 Jun 17;340(24):1888-99. doi: 10.1056/NEJM199906173402407. No abstract available.
Abou-Raya S, Abou-Raya A, Helmii M. Duloxetine for the management of pain in older adults with knee osteoarthritis: randomised placebo-controlled trial. Age Ageing. 2012 Sep;41(5):646-52. doi: 10.1093/ageing/afs072. Epub 2012 Jun 27.
Chappell AS, Desaiah D, Liu-Seifert H, Zhang S, Skljarevski V, Belenkov Y, Brown JP. A double-blind, randomized, placebo-controlled study of the efficacy and safety of duloxetine for the treatment of chronic pain due to osteoarthritis of the knee. Pain Pract. 2011 Jan-Feb;11(1):33-41. doi: 10.1111/j.1533-2500.2010.00401.x.
Wise BL, Niu J, Zhang Y, Wang N, Jordan JM, Choy E, Hunter DJ. Psychological factors and their relation to osteoarthritis pain. Osteoarthritis Cartilage. 2010 Jul;18(7):883-7. doi: 10.1016/j.joca.2009.11.016. Epub 2010 Mar 24.
Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.
Hilton L, Hempel S, Ewing BA, Apaydin E, Xenakis L, Newberry S, Colaiaco B, Maher AR, Shanman RM, Sorbero ME, Maglione MA. Mindfulness Meditation for Chronic Pain: Systematic Review and Meta-analysis. Ann Behav Med. 2017 Apr;51(2):199-213. doi: 10.1007/s12160-016-9844-2.
O'Leary K, O'Neill S, Dockray S. A systematic review of the effects of mindfulness interventions on cortisol. J Health Psychol. 2016 Sep;21(9):2108-21. doi: 10.1177/1359105315569095. Epub 2015 Feb 10.
Rosenkranz MA, Lutz A, Perlman DM, Bachhuber DR, Schuyler BS, MacCoon DG, Davidson RJ. Reduced stress and inflammatory responsiveness in experienced meditators compared to a matched healthy control group. Psychoneuroendocrinology. 2016 Jun;68:117-25. doi: 10.1016/j.psyneuen.2016.02.013. Epub 2016 Feb 20.
Yadav RK, Magan D, Mehta N, Sharma R, Mahapatra SC. Efficacy of a short-term yoga-based lifestyle intervention in reducing stress and inflammation: preliminary results. J Altern Complement Med. 2012 Jul;18(7):662-7. doi: 10.1089/acm.2011.0265.
MacCoon DG, Imel ZE, Rosenkranz MA, Sheftel JG, Weng HY, Sullivan JC, Bonus KA, Stoney CM, Salomons TV, Davidson RJ, Lutz A. The validation of an active control intervention for Mindfulness Based Stress Reduction (MBSR). Behav Res Ther. 2012 Jan;50(1):3-12. doi: 10.1016/j.brat.2011.10.011. Epub 2011 Nov 11.
Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.
Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.
Lange T, Vansteelandt S, Bekaert M. A simple unified approach for estimating natural direct and indirect effects. Am J Epidemiol. 2012 Aug 1;176(3):190-5. doi: 10.1093/aje/kwr525. Epub 2012 Jul 10.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1180036
Identifier Type: -
Identifier Source: org_study_id