Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults

描述（由研究者提供）：这是1 R 01 AG 031126 -01，老年人关节炎疼痛和关节炎的认知行为治疗的修订提交资料。骨关节炎（OA）疼痛影响所有60岁或以上的成年人的一半;其中大多数人还经历显著的睡眠障碍。由于疼痛引发并加重睡眠障碍，而睡眠不良反过来又维持并加重慢性疼痛，因此OA的最佳干预措施应针对疼痛和睡眠。虽然有有限的初步证据表明，这种干预可能有利于疼痛和睡眠，但缺乏大型，严格的随机对照试验来验证这一假设。这项拟议的研究将确定，相对于仅针对疼痛的干预和安慰剂对照，针对疼痛和共病睡眠障碍的干预是否能显著改善疼痛、睡眠和功能结局。在大型健康计划中寻求OA治疗的老年（>60岁）患者（当前数据库中N=5556）将筛查显著慢性疼痛和共病睡眠障碍。将375例患者随机分配至三个治疗组之一：8个疗程的疼痛认知行为治疗（CBT-P）计划，仅解决疼痛功能障碍; 8个疗程的疼痛和不适认知行为治疗（CBT-主要研究者）计划，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条件是基于先前证明对睡眠质量或感知疼痛没有影响的安慰剂对照干预。为了控制相关信息，所有三个组（CBT-P，CBT-Principal Investigator和SMW）都将收到关节炎帮助手册，其中提供有关疼痛控制，关节炎自我管理和睡眠卫生技术的信息。将在基线、治疗后（2个月）以及6、12和24个月随访时对受试者进行评估。我们假设：1）与CBT-P和SMW相比，CBT-主要研究者将在睡眠结局方面产生更大的初始和长期改善; 2）通过改善睡眠结局，CBT-主要研究者将在OA疼痛方面产生比CBT-P和SMW更大的初始和长期减少; 3）通过改善睡眠和疼痛结局，CBT-主要研究者将比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-主要研究者，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减少，为广泛的症状条件（包括疼痛和睡眠障碍）。拟议的试验还将提供迄今为止最大的实验评估，评估传统CBT对OA疼痛的有效性。鉴于最近对OA疼痛管理的药理学选择的限制，拟议的试验对改善快速增长的美国老年OA患者的疼痛和共病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衰弱，其中大多数人还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，针对患有疼痛性OA的老年人的疼痛和共病睡眠障碍的认知行为治疗是否会导致疼痛的大幅减轻以及睡眠和功能结局的改善。鉴于最近有效管理OA疼痛的药理学选择的局限性，该项目对改善快速增长的美国老年OA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.