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

NCT04334278 | Completed Results DMC

• 2 other identifiers: 673365R34AT010370-03
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Knee Osteoarthritis; Obesity; Depression

Outcome Measures

Primary Outcomes (1)

• Treatment Adherence

  Number of patients that attend a minimum of 4 of 6 weekly sessions

  6-weeks

Secondary Outcomes (3)

• Accelerometer Compliance

  Baseline, 6 weeks

• Number of Missing Specimens

  Baseline, 6 weeks

• Daily Practice Adherence

  6 weeks

Study Arms (2)

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.

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.

Behavioral: Health Enhancement Program

Interventions

GetHealthy-OA BEHAVIORAL

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.

GetHealthy-OA

Health Enhancement Program BEHAVIORAL

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.

Health Enhancement Program

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kentucky: lead
• Massachusetts General Hospital: collaborator
• Brigham and Women's Hospital: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

UK Healthcare at Turfland

Lexington, Kentucky, 40504, United States

Location

UK HealthCare Joint Reconstruction and Replacement

Lexington, Kentucky, 40508, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Obesity; Depression

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Caitlin Conley
• Organization: University of Kentucky

caitlin.conley2@uky.edu

8592571939

Study Officials

• Caitlin Conley, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 6, 2020
• Study Start: August 23, 2021
• Primary Completion: June 5, 2023
• Study Completion: June 5, 2023
• Last Updated: June 28, 2024
• Results First Posted: June 28, 2024

Record last verified: 2024-06

Locations

US (2)