Clinical trial NCT02498847: Occupational Therapy-Delivered Cognitive Behavioral Therapy for Symptomatic Knee Osteoarthritis
Official title: Occupational Therapy-Delivered Cognitive Behavioral Therapy for Symptomatic Knee Osteoarthritis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Knee Osteoarthritis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 57
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-Reported Physical Function-WOMAC
timeFrame: 5 minutes
Secondary outcomes:
measure: Objective Physical Function- 6 minute walk test
timeFrame: 6 minutes
measure: Pain - Brief Pain Inventory
timeFrame: 5 minutes
measure: Patient Global Impression of Change
timeFrame: <5 minutes
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Institute of Gerontology
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Associate Professor
name: Susan L Murphy, ScD OTR
role: PRINCIPAL_INVESTIGATOR
References: