Development of a Mind Body Program for Obese Knee Osteoarthritis Patients With Comorbid Depression

Summary

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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....

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 3RP-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 3RP-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 3RP-OA and control, and data collection procedures by group. A pilot randomized controlled trial (N=60 participants) of the 3RP-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 3RP-OA but rather to assess the feasibility of recruitment procedures (screening, eligibility, enrollment rates), feasibility and acceptability of the 3RP-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 4 3RP-OA groups and 4 control, 7-8 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 3RP-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 3RP-OA refined based on exit interviews and surveys. The control group will have the same format as the 3RP-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. To control for in between session practice, participants will receive an mp3 recording and informational handout to complete after each session.

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