Knee OsteoarthritisGetHealthy-OANCT04334278
Development of a Mind Body Program for Obese Knee Osteoarthritis Patients With Comorbid Depression
A study testing GetHealthy-OA and Health Enhancement Program in people with Knee Osteoarthritis and Obesity, run by University of Kentucky at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis, Obesity, Depression
- What is being tested?
- GetHealthy-OA and Health Enhancement Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Aug 2021to 5 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UK Healthcare at Turfland
Lexington, Kentucky, 40504
UK HealthCare Joint Reconstruction and Replacement
Lexington, Kentucky, 40508
About this study
Official title: Development of a Mind Body Program for Obese Knee Osteoarthritis Patients With Comorbid Depression: Does a Mind Body Program Reduce Osteoarthritis Pain?
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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Obesity, Depression
- Being tested
- GetHealthy-OA, Health Enhancement Program
- Medical subject headings
- Osteoarthritis, Knee, Obesity, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GetHealthy-OABehavioural
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.
Health Enhancement ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| GetHealthy-OA | Experimental | 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. Receives: Behavioral: GetHealthy-OA |
| Health Enhancement Program | Active comparator | 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. Receives: Behavioral: Health Enhancement Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Adherence
Number of patients that attend a minimum of 4 of 6 weekly sessions
Measured: 6-weeks
Secondary outcomes (3)
Accelerometer Compliance
Number of days participants wore the Accelerometers at least 8 hours per day
Measured: Baseline, 6 weeks
Number of Missing Specimens
Number of missing blood or urine specimens per patient
Measured: Baseline, 6 weeks
Daily Practice Adherence
Number of patients that completed daily practice at least 4 days per week
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start23 Aug 2021
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Brigham and Women's Hospital, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Caitlin Conley, University of Kentucky
- Investigators
- Caitlin Conley, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334278
- Sponsor's protocol ID
- 67336
- Other IDs
- 5R34AT010370-03
- Acronym
- GetHealthy-OA
- Status last verified
- Jun 2024
- First submitted
- 30 Mar 2020
- Last updated
- 28 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Mind Body Program for Obese Knee Osteoarthritis Patients With Comorbid Depression: Does a Mind Body Program Reduce Osteoarthritis Pain?
- ClinicalTrials.gov ID
- NCT04334278
- Acronym / sponsor ID
- GetHealthy-OA / 67336
- Conditions
- Knee Osteoarthritis, Obesity, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Brigham and Women's Hospital, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Posted 28 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GetHealthy-OA | Experimental | Behavioral: GetHealthy-OAThe 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. |
| Health Enhancement Program | Active comparator | Behavioral: Health Enhancement ProgramThe 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GetHealthy-OAThe 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. | Behavioural | GetHealthy-OA |
| Health Enhancement ProgramThe 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. | Behavioural | Health Enhancement Program |
Primary outcome
Treatment Adherence
Time frame: 6-weeks
Number of patients that attend a minimum of 4 of 6 weekly sessions
3 secondary outcomes
Accelerometer Compliance
Time frame: Baseline, 6 weeks
Number of Missing Specimens
Time frame: Baseline, 6 weeks
Daily Practice Adherence
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caitlin Conley, PhD principal investigator
University of Kentucky
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GetHealthy-OA and Health Enhancement Program in people with Knee Osteoarthritis and Obesity, run by University of Kentucky at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Adherence (time frame: 6-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.