Effects of Mindfulness-Based Stress Reduction on Knee Osteoarthritis

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.

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