Effects of Mindfulness-Based Stress Reduction on Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): Mindfulness-Based Stress Reduction; Health Enhancement Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention will be an MBSR course.; 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 name(s): Mindfulness; HEP
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Osteoarthritis; Knee Osteoarthritis; Knee Pain