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. Previous small trials of telephone CBT-I have reported positive insomnia outcomes, but no large randomized trials have assessed its long-term efficacy, impact on related outcomes in a primary care patient population, or cost-effectiveness. This proposal builds upon our successful completion of two randomized trials of CBT for insomnia with older adults: Lifestyles, a trial of group CBT in older adults with OA-related insomnia and pain, and MsFLASH04, a trial of telephone CBT-I for insomnia in menopausal women with comorbid vasomotor symptoms. 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 9 and 18 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. We hypothesize: 1) CBT-I will produce significantly greater initial and long-term improvements in sleep outcomes relative to EOC; 2) CBT-I will produce significantly greater initial and long-term improvements in pain, fatigue and mood relative to EOC; and 3) CBT-I will produce long-term reductions in health care utilization and costs relative to EOC. We will also explore whether changes in insomnia severity explain observed effects of CBT-I on secondary outcomes (mediator analysis), and whether CBT-I effects on insomnia differ by baseline insomnia, pain, or depression symptom severity (moderator analysis). 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.

Public Health Relevance

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.

National Institute of Health (NIH)
National Institute on Aging (NIA)
Research Project (R01)
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Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
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Romashkan, Sergei
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University of Washington
Schools of Medicine
United States
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