Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults

描述(由研究人员提供)：这是R01 AG031126-01的修订提交，老年人关节炎疼痛和失眠的认知行为治疗。骨性关节炎(OA)疼痛影响着所有60岁或60岁以上的成年人中的一半；他们中的大多数人还经历着严重的睡眠障碍。由于疼痛会引发并加剧睡眠障碍，而睡眠不佳反过来又会维持并加剧慢性疼痛，因此针对骨性关节炎的最佳干预措施应同时针对疼痛和睡眠。虽然有限的初步证据表明，这种干预可能对疼痛和睡眠都有好处，但缺乏一项大型、严格的随机对照试验来检验这一假说。这项拟议的研究将确定，与仅针对疼痛的干预和安慰剂对照组相比，同时针对疼痛和合并睡眠障碍的老年人的干预是否会显著改善疼痛、睡眠和功能结果。在大型健康计划中寻求治疗骨性关节炎的老年(60岁)患者(当前数据库中N=5556)将接受重大慢性疼痛和共病睡眠障碍的筛查。375名患者将被随机分为三个治疗组：单独针对疼痛功能障碍的8节认知行为疗法(CBT-P)计划；同时解决疼痛和睡眠障碍的8节认知行为疗法(CBT-首席研究员)计划；或8节节压力管理和健康安慰剂对照组。SMW的病情是基于安慰剂对照干预，此前证明对睡眠质量或感知到的疼痛没有影响。为了控制相关信息，所有三个小组(CBT-P、CBT-首席调查员和SMW)都将收到关节炎帮助手册，其中提供了有关疼痛控制、关节炎自我管理和睡眠卫生技术的信息。受试者将在基线、治疗后(2个月)以及6个月、12个月和24个月的随访时进行评估。我们假设：1)与CBT-P和SMW相比，CBT-首席调查员对睡眠结果的初始和长期改善显著更大；2)CBT-首席调查者，通过改善睡眠结果，将比CBT-P和SMW显著更大地减少OA疼痛；3)CBT-首席调查员，通过改善睡眠和疼痛结果，将比CBP-P和SMW在疼痛相关活动限制方面产生更大的初始和长期改善；)和4)CBT--首席调查员通过改善睡眠、疼痛和功能结果，将长期减少各种症状性疾病(包括疼痛和睡眠障碍)的医疗保健利用率和费用。这项拟议的试验还将提供迄今为止最大规模的实验评估，评估传统CBT治疗骨性关节炎疼痛的有效性。考虑到最近治疗骨性关节炎疼痛的药物选择的局限性，拟议中的试验对于改善快速增长的美国老年骨性关节炎患者的疼痛和合并睡眠障碍的管理具有重要意义。 公共卫生相关性：骨关节炎(OA)疼痛使一半的老年人虚弱，他们中的大多数人也经历了严重的睡眠障碍。该项目将确定，与目前的护理标准相比，针对疼痛和合并睡眠障碍的老年患者的认知行为治疗是否能显著减少疼痛，改善睡眠和功能结果。考虑到最近有效治疗骨性关节炎疼痛的药物选择的局限性，该项目对改善快速增长的患有骨性关节炎的老年美国人口中疼痛和共病睡眠障碍的管理具有重大意义。

DESCRIPTION (provided by investigator): 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. PUBLIC HEALTH RELEVANCE: 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.