Effects of Mindfulness-Based Stress Reduction on Knee Osteoarthritis (MBSR on KOA)

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University of California (UC) Davis

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Behavioral: Health Enhancement Program
Behavioral: Mindfulness-Based Stress Reduction

Study type

Interventional

Funder types

Other

Identifiers

NCT03527849
1180036

Details and patient eligibility

About

The purpose of this study is to see if stress reduction can lead to less pain due to knee osteoarthritis. To do this the investigators will compare two types of stress reduction modalities, Mindfulness-Based Stressed Reduction (MBSR) and a Health Enhancement Program (HEP). Both include stress reduction techniques, but MBSR has a mindfulness component that includes meditation. MBSR will be provided either in-person or online and HEP will be in-person. The assignment to the stress reduction program will be determined by the Principal Investigator. In order to assess for stress reduction and pain reduction the investigators will use validated measuring tools before, during, and after the course instructions.

Full description

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.

Enrollment

9 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

9 participants in 3 patient groups

In-Person MBSR Course
Experimental group
Treatment:
Behavioral: Mindfulness-Based Stress Reduction
Online MBSR Course
Experimental group
Treatment:
Behavioral: Mindfulness-Based Stress Reduction
In-Person HEP
Active Comparator group
Treatment:
Behavioral: Health Enhancement Program

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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