Group interventions for co-morbid insomnia and osteoarthritis pain in primary care: the lifestyles cluster randomized trial design.
Group interventions for co-morbid insomnia and osteoarthritis pain in primary care: the lifestyles cluster randomized trial design.
复制标题
初级保健中共病失眠和骨关节炎疼痛的团体干预：生活方式集群随机试验设计。
DOI：
10.1016/j.cct.2012.03.010
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发表时间：
2012
影响因子：
2.2
通讯作者：
Rybarczyk,BruceD
中科院分区：
文献类型：
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作者：
VonKorff,Michael;Vitiello,MichaelV;McCurry,SusanM;Balderson,BenjaminH;Moore,AmyL;Baker,LauraD;Yarbro,Patricia;Saunders,Kathleen;Keefe,FrancisJ;Rybarczyk,BruceD
对失眠和骨关节炎疼痛（CBT-PI）以及单独骨关节炎疼痛（CBT-P）进行为期六周的小组认知行为治疗，并与只接受教育的对照组（EOC）进行比较。关于疼痛和睡眠的基础教育具有可比性，因此EOC控制了信息和小组参与。积极干预在训练疼痛应对技能（CBT-P和CBT-PI）和睡眠增强技术（CBT-PI）方面与EOC不同。60岁及以上的骨关节炎患者通过邮寄调查的方式进行骨关节炎疼痛和失眠严重程度的筛查。主要结局是疼痛严重程度（疼痛强度和慢性疼痛分级量表的干扰评分）和失眠严重程度（失眠严重程度指数）。次要结局是关节炎疼痛（AIMS-2症状量表）和通过腕关节活动记录仪评估的睡眠效率。辅助结果包括：认知功能、抑郁和医疗保健使用。聚类随机设计提供了足够的能力来确定对主要结局的中度影响（效应量>0.35）。修改治疗意图分析，包括所有参加第一次会议的参与者，评估CBT-PI， CBT-P和EOC组的效果。在干预后（2个月）和9个月时评估治疗效果，并在18个月时评估干预效果的持久性。该试验在6个初级诊所进行，随机分配了367名参与者，其中93.2%的随机患者至少参加了4次小组会议。干预后和9个月评估的有效率分别为96.7%和92.9%。该混合疗效试验设计评估了当在初级保健环境中实施干预措施时，相对于仅进行教育控制，干预措施是否对临床和行为结果产生特定的益处。
Six weekly sessions of group cognitive–behavioral therapy for insomnia and osteoarthritis pain (CBT-PI), and for osteoarthritis pain alone (CBT-P) were compared to an education only control (EOC). Basic education about pain and sleep was comparable, so EOC controlled for information and group participation. Active interventions differed from EOC in training pain coping skills (CBT-P and CBT-PI) and sleep enhancement techniques (CBT-PI). Persons with osteoarthritis age 60 or older were screened for osteoarthritis pain and insomnia severity via mailed survey. Primary outcomes were pain severity (pain intensity and interference ratings from the Graded Chronic Pain Scale) and insomnia severity (Insomnia Severity Index). Secondary outcomes were arthritis pain (AIMS-2 symptom scale) and sleep efficiency assessed by wrist actigraphy. Ancillary outcomes included: cognitive function, depression, and health care use. A clustered randomized design provided adequate power to identify moderate effects on primary outcomes (effect size>0.35). Modified intent to treat analyses, including all participants who attended the first session, assessed effects across CBT-PI, CBT-P, and EOC groups. Treatment effects were assessed post-intervention (2months) and at 9months, with durability of intervention effects evaluated at 18months. The trial was executed in 6 primary clinics, randomizing 367 participants, with 93.2% of randomized patients attending at least 4 group sessions. Response rates for post-intervention and 9month assessments were 96.7% and 92.9% respectively. This hybrid efficacy–effectiveness trial design evaluates whether interventions yield specific benefits for clinical and behavioral outcomes relative to an education only control when implemented in a primary care setting.