- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04334278
Development of a Mind Body Program for Obese Knee Osteoarthritis Patients With Comorbid Depression (GetHealthy-OA)
Development of a Mind Body Program for Obese Knee Osteoarthritis Patients With Comorbid Depression: Does a Mind Body Program Reduce Osteoarthritis Pain?
Study Overview
Status
Conditions
Intervention / Treatment
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 activity, and recommendations of multimodal programs to improve outcomes in chronic pain clinical trials. Adaptations of the multimodal general 3RP will be done consistent with theoretical models of the fear-avoidance model of pain, cognitive model of pain and depression, acceptance and commitment therapy, mindfulness, and positive psychology. The goal is to help patients engage in activities that are meaningful and mapped to each individual's level of functioning and life circumstance through the use of quota-based pacing through adaptation of skills to directly address improved mood, healthy lifestyle (sleep, diet), correction of knee osteoarthritis misconceptions, and use of relaxation response elicitation and positive psychology skills to promote awareness and calm during activities, even when these are painful.
The guiding hypothesis is that the synergistic interaction between mindfulness, adaptive thinking, positive psychology, physical activity and healthy living skills of the GetHealthy-OA reduces pro-inflammatory cytokine expression while also promoting optimal mechanical loading of the cartilage thus slowing the progression of symptomatic knee OA. In this project the 3RP will be iteratively adapted for the needs of knee osteoarthritis patients with depression and obesity with a focus on gradual increases in physical activity measured with accelerometers and establish feasibility markers for the program and procedures. A pilot randomized controlled trial of the GetHealthy-OA versus a time- and attention-matched health enhancement control will be performed to assess the feasibility of recruitment procedures, feasibility and acceptability of the GetHealthy-OA and control, and data collection procedures by group.
A pilot randomized controlled trial (N=60 participants) of the GetHealthy-OA with a time and attention matched health enhancement control will be performed. The end goal of the pilot RCT is not to assess the efficacy of the GetHealthy-OA but rather to assess the feasibility of recruitment procedures (screening, eligibility, enrollment rates), feasibility and acceptability of the GetHealthy-OA and control intervention (adherence, retention, fidelity, satisfaction, group telehealth delivery, and data collection procedures by group (adherence, satisfaction, blood and urine biomarker data).
A single blind pilot feasibility randomized controlled trial with a time, dose and attention matched health enhancement control will be conducted (N=60; approximately 5 GetHealthy-OA groups and 5 control, 6-8 per group). Participants will be randomized in a 1:1 design using a randomization scheme developed by the statistician. Research procedures will be identical for patients in GetHealthy-OA and control. The study will yield information on how participants might engage differently with the intervention and control, definitive information on feasibility and acceptability and signal of improvement in the intervention before investment of resources in the full randomized controlled trial.
The GetHealthy-OA refined based on exit interviews and surveys. The control group will have the same format as the GetHealthy-OA, and the control group follows the format of the Health Enhancement Program. A pain specific adaptation of this program for chronic pain exists. This program will be adapted for the specific needs of patients with knee osteoarthritis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Caitlin Conley, PhD
- Phone Number: 859-257-2939
- Email: caitlin.conley2@uky.edu
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40504
- UK Healthcare at Turfland
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Lexington, Kentucky, United States, 40508
- UK HealthCare Joint Reconstruction and Replacement
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GetHealthy-OA
The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity.
The GetHealthy-OA will be delivered by secure telehealth.
|
The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity.
The GetHealthy-OA will be delivered by secure telehealth.
|
Active Comparator: Health Enhancement Program
The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis.
It is an 6-week group mind body program that will be delivered via secure telehealth.
To control for in between session practice, participants will receive an mp3 recording and informational handout to complete after each session.
|
The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis.
It is an 6-week group mind body program that will be delivered via secure telehealth.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Adherence
Time Frame: Baseline
|
Number of patients that attend a minimum of 4 of 6 weekly sessions
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accelerometer Compliance
Time Frame: Baseline, 6 weeks
|
Number of days participants wore the Accelerometers at least 8 hours per day
|
Baseline, 6 weeks
|
Number of Missing Specimens
Time Frame: Baseline, 6 weeks
|
Number of missing blood or urine specimens
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Baseline, 6 weeks
|
Daily Practice Adherence
Time Frame: 6 weeks
|
Number of patients that completed daily practice at least 4 days per week
|
6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Caitlin Conley, PhD, University of Kentucky
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 67336
- 5R34AT010370-03 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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