Occupational Therapy-Delivered Cognitive Behavioral Therapy for Symptomatic Knee Osteoarthritis (ENGAGE)

Occupational Therapy-Delivered Cognitive Behavioral Therapy for Symptomatic Knee Osteoarthritis: A Pilot Study

Knee osteoarthritis (OA) affects 27 million US adults and is a leading cause of pain and disability. Non-pharmacological interventions are recommended but are underutilized. Exercise reduces pain and improves physical function, but benefits tend to wane without a component to facilitate behavior change. Cognitive behavioral therapy (CBT) has long term benefits on pain and physical function in individuals with OA, but is not typically offered in clinical care. CBT could be taught in the context of clinical care by occupational therapists (OT). OTs help people manage chronic conditions by teaching behavioral strategies that promote health and function. The purpose of this study is to test the feasibility and efficacy of an OT-delivered cognitive behavioral therapy program to help people manage their knee OA.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Behavioral: ENGAGE

Detailed Description

Knee OA, in particular, is a major driver of health care costs and is also a leading cause of arthritis-related activity limitations. A common assumption in knee OA treatment is that relief of joint pain will lead to improvements in physical function. However, many factors can influence disability in OA, not only the biomechanical factors which have been the focus of traditional rehabilitation. Although research supports a broader biopsychosocial approach to knee OA treatment, it has not been broadly adopted into clinical treatments. The biopsychosocial model posits that pain and disability are not only affected by pathophysical (e.g., biological) factors, but also psychological (e.g., depression, coping, self-efficacy) and social factors (e.g., social support, response of significant other).

One approach to offering psychosocial aspects in the context of pain treatment has been via CBT, a common psychosocial intervention, with evidence supporting its efficacy in OA. Despite the evidence, CBT is rarely integrated into actual clinical practice for people with knee OA. Barriers to integration have included limited access to psychologists (particularly in rural settings), difficulties coordinating primary care physicians with psychological practices, inconsistent reimbursement of psychological services for OA pain, and inconsistent standardization of treatments across settings. The current study aims to overcome barriers that have previously limited access to a biopsychosocial approach to knee OA treatments by integrating cognitive and behaviorally-based self-management training into a new rehabilitation intervention offered through occupational therapy, an allied medical field which commonly teaches behavioral strategies to improve physical function in many clinical populations. Because this approach will be manualized, it will provide the opportunity for easy adoption into clinical practice.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Ann Arbor, Michigan, United States, 48109-2007
      • University of Michigan Institute of Gerontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• community-living
• report of at least mild to moderate pain in knee with osteoarthritis
• clinical determination of knee osteoarthritis
• report of knee pain for > 3 months duration
• ambulatory with or without cane or walker
• has internet access and can use computer

Exclusion Criteria:

• severe physical impairment
• current cancer treatment
• knee injections or surgery in previous 3 months
• using long-acting narcotics
• shift workers
• participation in rehabilitation or behavioral therapy for OA in the previous year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ENGAGE intervention; 8 in-person weekly treatment sessions with an occupational therapist of 30 minutes - 1 hour duration intervention content provided on website, homework assigned each week after intervention period, monthly calls conducted to check on health status	Behavioral: ENGAGE; Participants are introduced to ENGAGE program by the study OT. The ENGAGE program is located on a website and has several modules. The modules include a video in which a health provider is featured. This health provider gives a short presentation on a topic related to OA, symptom management or lifestyle change. Within each module, there is downloadable homework and additional information which can be printed. The modules are: What is Osteoarthritis?; Information about treatments; Exercise; Sleep hygiene; Relaxation; Pleasant Activity Scheduling; Goal setting; Problem Solving; Pacing; Communication
No Intervention: Usual Care; participated in usual care and received monthly calls to check on health status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported Physical Function-WOMAC	Western Ontario and McMaster University Arthritis Index (WOMAC) 17 items, participants rate difficulty in performing different activities on a 0 - 4 scale	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Physical Function- 6 minute walk test	The 6 minute walk test involves walking at usual pace for 6 minutes over a flat surface. Overall distance is recorded (in feet).	6 minutes
Pain - Brief Pain Inventory	10 item scale in which participants report their pain severity and interference on a 0 - 10 scale	5 minutes
Patient Global Impression of Change	Participant answers one question. Overall how do you feel since you started participating in this study? on a scale of very much improved (1) - very much worse (7)	<5 minutes

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Susan L Murphy, ScD OTR, Associate professor

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: July 13, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 15, 2015

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: HUM00067979