Development of a Mind Body Program for Obese Knee Osteoarthritis Patients With Comorbid Depression: Does a Mind Body Program Reduce Osteoarthritis Pain?
Phase: NA
Conditions: Knee Osteoarthritis, Obesity, Depression
Sponsor: University of Kentucky

 
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Document Coversheet 
 
 
Study Title: Development of a Mind Body Program for Obese Knee Osteoarthritis Patients 
With Comorbid Depression: Does a Mind Body Program Reduce Osteoarthritis Pain? 
 
Institution/Site: 
University of Kentucky 
Document (Approval/Update) Date: 
08/16/2021 
NCT Number: 
NCT04334278 
IRB Number 
67336 
Coversheet created: 
06/04/2024 
 
 

 
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Development of a Mind Body Program for Obese Knee Osteoarthritis Patients with 
Comorbid Depression 
 
Materials and Methods 
Participants and Recruitment 
60 different patients will be enrolled in the feasibility RCT. Eligible patients with mild to 
moderate knee OA, using standard diagnostic criteria, will be referred by seven physicians at the 
University of Kentucky (UK) Healthcare Hip & Knee Center and the UK Healthcare Orthopedic 
& Sports Medicine Center during regularly scheduled office visits. Standard diagnostic criteria 
will include clinical examination, patient-reported symptoms/functional limitations, and 
radiographic assessments. In addition, because the study activities can all be completed remotely, 
the IRB-approved study flyer will be circulated electronically at the participating institutions as 
well as by patient adovacate groups such as the Arthritis Foundation. 
Inclusion criteria are: obesity (BMI > 30 kg/m2), idiopathic knee OA1 with mild to 
moderate radiographic changes (Kellgren/Lawrence grade 2 or 32 or Knee injury and 
Osteoarthritis Outcome Scores (KOOS) consistent with knee OA3), elevated depressive 
symptoms (PHQ-9 > 104-6), age 45 or older7,8, history of concurrent psychotropics for < 2 weeks 
prior to initiation of treatment or on stable doses for > 6 weeks, access to an internet-enabled 
computer/smart phone, willingness to comply with the study protocol and assessments, and 
cleared by a medical doctor to participate. Exclusion criteria are: any disorder requiring the use 
of systemic corticosteroids; rheumatoid arthritis; history of cancer within 5 years of screening; 
unable to walk/wheelchair-bound; prior surgical fixation of a femur or tibia fracture; taking high 
doses of opioid pain medication (>50 milligrams of morphine equivalent per day); diagnosis of a 
medical illness expected to worsen in the next 6 months (e.g., malignancy); active suicidal 

 
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ideation or past-year psychiatric hospitalization; non-English speaking; lifetime history of 
schizophrenia, bipolar disorder, or other psychotic disorder; current substance abuse or 
dependence (or a history within the past 6 months); practice of yoga/meditation, or other mind 
body techniques once per week > 45 min within the last 3 months; engagement in regular 
moderate or vigorous physical exercise for >30 min daily. These criteria are consistent with other 
clinical trials in knee OA or mind-body interventions.8,9 Patients with reduced or altered capacity 
due to administration of any mind-altering substances such as tranquilizers, conscious sedation 
or anesthesia, brain injury, or age outside of the targeted range will not be recruited for 
participation in this study. 
Enrollment and baseline data collection (self-report questionnaires, blood draws, urine 
samples) will coincide with the patient’s office visit with their treating physician and will not 
require an additional visit. After providing verbal consent, potential participants will meet with a 
research assistant for study screening. If the screening indicates that the patient meets all 
inclusion and exclusion criteria, study staff will begin the written informed consent process.  
Eligible participants will undergo written informed consent prior to the baseline 
assessments. Due to the sensitive data collected in this study, patients will review and sign the 
combined informed consent and HIPAA-authorization if they choose to participate. The 
informed consent process will take place in a dedicated research room at either facility to ensure 
that both the patient and research team have adequate time and privacy. A specific item will be 
included on the Informed Consent and Data Collection Checklist Forms to ensure that “Patients 
were asked if they had any questions (Yes / No).” The patient will then be given the option to 
provide informed consent that day, to return on a different day, or opt out. Study staff will 
coordinate scheduling to continue the informed consent process with patients as needed. A copy 

 
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of the completed informed consent will be given to patients, added to their medical records, and 
documented in study progress notes.  
Live Video Delivery 
Participants will be recruited in-person at the University of Kentucky, but will also be 
recruited via electronic means at the other study sites (Massachusetts General Hospital (MGH) 
and Brigham & Women’s Hospital (BWH)). In addition, because the study activities can all be 
completed remotely, the IRB-approved study flyer will be circulated electronically by patient 
adovacate groups such as the Arthritis Foundation. The intervention will be performed remotely 
by the study team at MGH via live video through a HIPPA-approved software used in clinical 
practice at MGH for a variety of medical populations. We have extensive experience with 
delivery of similar mind-body programs and focus groups via live video.102,121 After enrollment, 
participants will receive an emailed link for one-click installation of the video software. A 
research assistant will offer participants a test call and assist with installation as needed. 
Participants will receive a reminder email about the appointment information and a link to access 
the virtual group session. The research assistant will be available to assist participants in real 
time with any technical challenges they may experience during the treatment sessions. 
Pilot Randomized Controlled Trial 
The goal of the pilot RCT is to assess the feasibility of recruitment procedures (e.g., 
screening, eligibility, enrollment rates), the feasibility and acceptability of the GetActive-OA and 
control interventions (e.g., adherence, retention), and the feasibility of data collection procedures 
by group (e.g., adherence, accelerometer data, blood and urine biomarker data). In line with 
common guidelines for feasibility studies 47, we will not test efficacy or perform between-group 
analyses. 

 
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We will enroll up to 60 patients with 3-8 participants per group. Participants will be 
randomized in a 1:1 design using a randomization scheme developed by the study statistician. 
The control group will have the same format and procedures as the GetActive-OA and will 
follow the format of the HEP.10 We will modify this program for the specific needs of patients 
with knee OA. Session structure is outlined in Table 3. To control for between-session practice, 
participants will receive an audio recording and informational handout to complete after each 
session. All of the patient education information, in a simplified form, will be included as an 
appendix in the GetActive-OA manual. We have successfully used this procedure in our clinical 
trial in neurofibromatosis.10  
Table 3. Structure of the Health Enhancement Program to be utilized with the control 
group 
Session 
Health Enhancement Program Topics 
1 
Educational information on depression, obesity and knee function including the role of 
inflammation 
 2-3 
Educational information on physical activity and effects on mood, weight and knee 
function 
 4-5 
 
Educational information on nutrition  
 6 
Educational information on sleep 
 7 
Educational information on navigating medical care 
 8 
Review 
  
Analysis Plan  
We will calculate descriptive statistics and report definitive feasibility and acceptability 
markers for the GetActive-OA, the control intervention, and the study data collection and 
analysis procedures. We will report feasibility as number of participants approached, screened, 
eligible, and enrolled. We will report number of participants who completed at least 4 out of the 

 
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6 sessions (67%). The research team’s senior orthopedic researcher will assess the number of 
days participants wore the accelerometers at baseline and post-test using the active wear time of 
8 hours/day. The research team’s senior orthopedic researcher will assess the number of missing 
specimens (blood, urine). This will provide a realistic assessment of the study procedures as they 
will occur during the fully-powered efficacy trial, information on how participants might engage 
differently with the intervention and control, and signal of improvement in the intervention 
before investment of resources in the full RCT. 
 
References 
1. 
Altman R, Asch E, Bloch D, et al. Development of criteria for the classification and 
reporting of osteoarthritis: classification of osteoarthritis of the knee. Arthritis Rheum. 
1986;29:1039-1049. 
2. 
Kellgren JH, Lawrence JS. Radiological assessment of osteoarthritis. Ann Rheum Dis. 
1957;16:494-502. 
3. 
Englund M, Roos EM, Lohmander LS. Impact of type of meniscal tear on radiographic 
and symptomatic knee osteoarthritis. a sixteen-year followup of menisectomy with 
matched controls. Arthritis Rheum. 2003;48(8):2178-2187. 
4. 
Rosemann T, Backenstrass M, Joest K, Rosemann A, Szecsenyi J, Laux G. Predictors of 
depression in a sample of 1,021 primary care patients with osteoarthritis. Arthritis 
Rheum. 2007;57(3):415-422. 
5. 
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity 
measure. J Gen Intern Med. 2001;16:606-613. 
6. 
Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of 
PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders: 
Patient Health Questionnaire. . JAMA. 1999;282:1737-1744. 
7. 
McGowan JA. Perspectives on the future of bone and joint diseases. J Rheumatol Suppl. 
2003;67:62-64. 
8. 
O’Moore KA, Newby JM, Andrews G, et al. Internet cognitive behaviour therapy for 
depression in older adults with knee osteoarthritis: A randomized controlled trial. 
Arthritis Care Res. 2018;70(1):61-70. 
9. 
Vranceanu AM, Ricklin E, Merker V, Park E, Plotkin SR. Mind body therapy for patients 
with neurofibromatosis via live video; an RCT. Neurology. 2016;87(8):806-814. 
10. 
Vranceanu AM, Zale EL, Funes CJ, et al. Mind-body treatment for international English-
speaking adults with neurofibromatosis via live videoconferencing: protocol for a single-
blind randomized controlled trial. JMIR Res Protoc. 2018;7(10):e11008.