This is a revised submission of 1 R01 AG031126-01, Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults. Osteoarthritis (OA) pain affects half of all adults age 60 or older;the majority of whom also experience significant sleep disturbance. Since pain initiates and exacerbates sleep disturbance and poor sleep in turn maintains and exacerbates chronic pain, optimal interventions for OA should target both pain and sleep. While there is limited preliminary evidence that such an intervention may benefit both pain and sleep, a large, rigorous randomized controlled trial testing this hypothesis is lacking. The proposed study will determine whether an intervention that targets both pain and co-morbid sleep disturbance in older adults with painful OA and disturbed sleep yields substantially improved pain, sleep and functional outcomes relative to both an intervention targeting pain alone and a placebo-control. Older (>60 yrs) patients (N=5556 in current database) who have sought treatment for OA in a large health plan will be screened for significant chronic pain and co-morbid sleep disturbance. Three hundred seventy five patients will be randomized to one of three treatment groups: an 8-session Cognitive-Behavioral Therapy for Pain (CBT-P) program addressing pain dysfunction alone;an 8-session Cognitive-Behavioral Therapy for Pain and Insomnia (CBT- Principal Investigator) program addressing both pain and sleep disturbance;{or an 8-session Stress Management and Wellness (SMW) placebo-control group. The SMW condition is based on a placebo-control intervention previously demonstrated to have no effect on sleep quality or perceived pain. To control relevant information, all three groups (CBT-P, CBT-Principal Investigator and SMW) will receive the Arthritis Helpbook, which provides information on pain control, arthritis self-management, and sleep hygiene techniques. Subjects will be assessed at baseline, post-treatment (2-months) and at 6, 12 and 24-month follow-ups. We hypothesize that: 1) CBT-Principal Investigator will produce significantly greater initial and long-term improvements in sleep outcomes relative to both CBT-P and SMW;2) CBT-Principal Investigator, by improving sleep outcomes, will produce significantly greater initial and long-term reductions in OA pain than both CBT-P and SMW;3) CBT-Principal Investigator, by improving both sleep and pain outcomes, will produce greater initial and long-term improvements in pain-related activity limitations than both CBP-P and SMW;} and 4) CBT-Principal Investigator, by improving sleep, pain and functional outcomes, will produce long-term reductions in health care utilization and costs for a broad range of symptomatic conditions (including pain and sleep disturbance). The proposed trial will also provide the largest experimental evaluation to date assessing the effectiveness of conventional CBT for OA pain. Given recent limitations on pharmacologic options for management of OA pain, the proposed trial has important implications for improving management of both pain and co-morbid sleep disturbance in the rapidly growing population of older Americans with OA.
Osteoarthritis (OA) pain debilitates half of all older adults, most of whom also experience significant sleep disturbance. This project will determine whether a cognitive-behavioral treatment targeting both pain and co- morbid sleep disturbance in older adults with painful OA results in substantially greater reductions in pain and improvements in sleep and functional outcomes compared to current standards of care. Given the recent limitations on pharmacologic options for effective management of OA pain, this project has major implications for improving management of both pain and co-morbid sleep disturbance in the rapidly growing population of older Americans suffering from OA.
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