OsteoArthritis and Therapy for Sleep

Osteoarthritis (OA) pain affects 50 percent of older adults, more than half of whom also experience significant sleep disturbance. This randomized trial will determine whether a telephone-based cognitive behavioral treatment targeting insomnia in older adults with chronic severe OA-related insomnia and pain results in substantially greater reductions in insomnia severity and in related improvements in pain, fatigue, mood, quality of life and healthcare costs compared to telephone-delivered education (attention control) about insomnia. The trial will test an intervention that if demonstrated to have long term efficacy is scalable and has the potential for wide-scale deployment in healthcare systems.

Twenty-five percent of older adults experience significant osteoarthritis (OA)-related comorbid sleep disturbance. Insomnia is associated with substantial negative effects on function, mood, and medical resource utilization. Cognitive behavioral therapy for insomnia (CBT-I) is evidence based and has been shown to be efficacious in populations with a variety of comorbid conditions including OA-related chronic pain. However, in-person CBT interventions are unlikely to be widely deployable in healthcare systems. Telephone delivery has the advantage of giving patients access to personalized, efficacious CBT-I interventions from home, increasing generalizability, and outreach to minority, rural, and other underserved populations. Older (60+ yrs) primary care patients across Washington State will be screened for severe persistent OA-related insomnia and pain. Two hundred and seventy patients will be randomized to either CBT-I or an education only attention control (EOC). Each treatment will consist of six 20-30 minute telephone-based sessions over an eight week period. Pre-treatment, post-treatment (2 months and 12 month) assessments will include measures of sleep, pain, fatigue, mood, and quality of life. A cost effectiveness evaluation of the intervention will also be conducted. The proposed research will determine if telephone CBT-I improves OA insomnia and associated outcomes in a state-wide primary care population of older adults, and inform policy decisions about widespread dissemination of telephone CBT-I in this and related patient populations.

Eligibility Criteria:
Inclusion Criteria:

* Age 60+ with one or more health care visits for OA in the prior 3 years
* Score of ≥6 on 4-item ISI at first screening and ≥11 on full ISI at second screening
* Score of ≥9 on two items from the Brief Pain Inventory (BPI) asking about average pain intensity in the past 2 weeks (0-10 scale) and activity interference due to pain (0-10 scale) at first and second screening

Exclusion Criteria:

* Not continuously enrolled at Group Health Cooperative for at least one year
* Prior diagnosis of a primary sleep disorder: sleep apnea with an AHI/RDI score of 15+ or current use of a CPAP machine; periodic leg movement disorder; restless leg syndrome; sleep-wake cycle disturbance; or rapid eye movement behavior disorder
* Diagnosis in the medical record of: rheumatoid arthritis, terminal disease, being considered for major surgery, active chemotherapy or radiation for cancer, or inpatient treatment for congestive heart failure within the previous 6 months
* Diagnosis of dementia, use of acetylcholinesterase inhibitor and/or memantine for cognitive impairment, or cognitive impairment (\>6 on the Short Orientation-Memory-Concentration Test)
* Hearing or speech impairment sufficient to preclude participation in a telephone intervention