Status:
COMPLETED
Development of a Mind Body Program for Obese Knee Osteoarthritis Patients With Comorbid Depression
Lead Sponsor:
University of Kentucky
Collaborating Sponsors:
Massachusetts General Hospital
Brigham and Women's Hospital
Conditions:
Knee Osteoarthritis
Obesity
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
Knee osteoarthritis (OA) is the most common joint disorder in the U.S. and a leading cause of disability. Depression and obesity are highly comorbid among knee osteoarthritis patients, and the combina...
Detailed Description
The conceptual model of adaptation of the general 3RP to obese osteoarthritis patients with depression that specifically target improved function through combining mind body skills with physical activ...
Eligibility Criteria
Inclusion
- Obese patients (BMI \> 30 kg/m2)
- Idiopathic knee OA per the American College of Rheumatology classification with mild to moderate radiographic changes (Kellgren/Lawrence grade 2 or 3)
- Current elevated depressive symptoms (PHQ-9 \> 9)
- Age 45 or older
- Free of concurrent psychotropics for \< 2 weeks prior to initiation of treatment or on stable doses for \> 6 weeks
- Access to a computer/smart phone with internet access
- Willingness to comply with the study protocol and assessments
- Cleared by a medical doctor to participate
Exclusion
- 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)
- Diagnosis of a medical illness expected to worsen in the next 6 months (e.g., malignancy)
- Active suicidal ideation or past-year psychiatric hospitalization
- Non-English speaking
- Current severe depression symptoms (PHQ-9 \> 19)
- Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder
- Current substance abuse or dependence
- Substance use disorder within the past 6 months
- Practice of yoga/meditation, or other mind body techniques that elicit the relaxation response, once per week for 45 min or more within the last 3 months
- Engagement in regular moderate or vigorous physical exercise for \>30 min daily
Key Trial Info
Start Date :
August 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04334278
Start Date
August 23 2021
End Date
June 5 2023
Last Update
June 28 2024
Active Locations (2)
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1
UK Healthcare at Turfland
Lexington, Kentucky, United States, 40504
2
UK HealthCare Joint Reconstruction and Replacement
Lexington, Kentucky, United States, 40508