Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04334278 |
| Other study ID # |
67336 |
| Secondary ID |
5R34AT010370-03 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 23, 2021 |
| Est. completion date |
June 5, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
University of Kentucky |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 combination of obesity and depression is associated with decreased physical activity,
higher pain and disability, and more rapid cartilage degradation. Depression, obesity and
osteoarthritis exacerbate one another and share a common pathophysiology involving systemic
inflammation and pro-inflammatory cytokines, reflecting a complex mind-body interaction.
Current treatments for knee osteoarthritis offer little to no benefit over placebo, and do
not emphasize mind-body practices or physical activity to target the underlying
pathophysiology. Mind-body interventions to lessen depressive symptoms and increase physical
activity offer the ability to target biological, mechanical and psychological mechanisms of
osteoarthritis progression in this high-risk subset. The long-term goals are to evaluate the
mechanisms by which the Relaxation Response Resiliency Program (3RP) delivered via
telehealth, and adapted for patients with depression, obesity and knee OA (GetHealthy-OA)
promotes increases in physical activity and improved subjective and objective aspects of knee
health. The overarching hypothesis is that the synergistic interaction between mindfulness,
adaptive thinking, positive psychology and healthy living skills of the GetHealthy-OA will
reduce pro-inflammatory cytokine expression while also promoting optimal mechanical loading
of the cartilage thereby slowing the progression of symptomatic knee osteoarthritis. This
study aims to adapt the 3RP for the needs of knee osteoarthritis patients with depression and
obesity with a focus of increasing physical activity, and iteratively establish the
feasibility, credibility and acceptability of the programs and research procedures.
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.
