Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults

描述（由研究者提供）：这是一份修订后的1 R01 AG031126-01，老年人关节炎疼痛和失眠的认知行为疗法。骨关节炎（OA）疼痛影响了所有60岁或以上的成年人的一半；他们中的大多数人也有严重的睡眠障碍。由于疼痛引发并加剧了睡眠障碍，而睡眠不足反过来又维持并加剧了慢性疼痛，因此OA的最佳干预措施应该同时针对疼痛和睡眠。虽然有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，但缺乏大型、严格的随机对照试验来验证这一假设。拟议的研究将确定，相对于单独针对疼痛和安慰剂对照的干预，针对疼痛性OA和睡眠障碍的老年人的疼痛和共病性睡眠障碍的干预是否能显著改善疼痛、睡眠和功能结果。在大型健康计划中寻求OA治疗的老年（60岁至60岁）患者（当前数据库中N=5556）将筛查明显的慢性疼痛和合并症睡眠障碍。375名患者将被随机分配到三个治疗组之一：一个8期的疼痛认知行为治疗（CBT-P）计划，单独解决疼痛功能障碍；一个针对疼痛和失眠的8期认知行为疗法（CBT-首席研究员）项目，解决疼痛和睡眠障碍；{或8个疗程的压力管理和健康（SMW）安慰剂对照组。SMW的条件是基于安慰剂控制干预，先前证明对睡眠质量或感知疼痛没有影响。为了控制相关信息，所有三组（CBT-P、cbt -主要研究者和SMW）都将收到关节炎帮助手册，其中提供了疼痛控制、关节炎自我管理和睡眠卫生技术方面的信息。受试者将在基线、治疗后（2个月）以及6、12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-Principal研究者在睡眠结果的初始和长期改善方面显著更大；2)与CBT-P和SMW相比，CBT-Principal研究者通过改善睡眠结果，将产生更大的初始和长期OA疼痛减少；3)与CBP-P和SMW相比，CBT-Principal研究者通过改善睡眠和疼痛结果，将在疼痛相关活动限制方面产生更大的初始和长期改善；4) cbt -首席研究员，通过改善睡眠、疼痛和功能结果，将产生长期的医疗保健利用和成本的降低，广泛的症状条件（包括疼痛和睡眠障碍）。拟议的试验也将提供迄今为止最大的实验评估，评估传统CBT治疗OA疼痛的有效性。考虑到最近治疗骨关节炎疼痛的药理学选择的局限性，这项拟议的试验对改善快速增长的美国老年骨关节炎患者的疼痛和共病睡眠障碍的管理具有重要意义。

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.