Stepped Care for Depression and Musculoskeletal Pain

描述（由申请人提供）：在美国，疼痛是近20%的初级保健就诊的主诉，每年有超过1亿的诊所就诊。疼痛每年给美国带来的医疗保健和生产力损失超过1000亿美元。三分之二的与疼痛相关的医疗保健就诊与肌肉骨骼疼痛有关，腰背、臀部和膝盖是最常见的部位。研究一致表明，至少有三分之一的疼痛患者伴有抑郁，并且共病的疼痛和抑郁对症状特异性（即疼痛和抑郁减轻）以及与健康相关的生活质量（HRQL）结果都有相互的不良影响。目前尚不确定的是，在初级保健中改善抑郁症预后的治疗策略是否对合并疼痛和抑郁症的患者有效。因此，我们建议开展情感性障碍和肌肉骨骼疼痛的阶梯式护理（SCAMP）研究，设计为前瞻性队列研究中的随机临床试验。SCAMP将招募500名患有下背部、臀部或膝盖肌肉骨骼疼痛的患者。在这些人中，一半会有临床上明显的抑郁症，一半不会有抑郁症。这250名抑郁症患者将随机分为阶梯治疗组和常规治疗组。分步护理组将接受12周的指导一致抗抑郁治疗（第一步），由抑郁症疼痛临床专家（DPCS）护士病例管理人员管理。12周后疼痛未得到充分改善或整体改善的患者将接受DPCS的一系列6个手动的、基于证据的疼痛自我管理会议（步骤2）。试验中的250名抑郁症患者将在基线、1、3、6和12个月接受由治疗组盲法访谈者进行的综合结果评估，而队列中的250名非抑郁症患者将在基线、3和12个月接受类似的评估。我们的主要目的是测试阶梯式护理是否比常规护理更有效地改善抑郁和疼痛的共同主要结局。其次，我们将测试干预对HRQL、疼痛信念和行为以及医疗保健成本的影响。对非抑郁队列的纵向评估将确定偶发性抑郁的频率和危险因素。

DESCRIPTION (provided by applicant): Pain is a presenting complaint in nearly 20% of all primary care visits in the United States, accounting for more than 100 million clinic visits annually. Pain costs the U.S. over $100 billion each year in health care and lost productivity. Two-thirds of pain-related health care visits are related to musculoskeletal pain with the low back, hip and knee being the most common sites. Studies have consistently shown that at least one-third of patients with pain suffer from concomitant depression, and that comorbid pain and depression have reciprocal adverse effects on both symptom-specific (i.e., pain and depression reduction) as well as health-related quality of life (HRQL) outcomes. What is not established is whether treatment strategies shown to improve outcomes for depression in primary care are effective in patients with comorbid pain and depression. Therefore, we propose to conduct the Stepped Care for Affective disorders and Musculoskeletal Pain (SCAMP) study, designed as a randomized clinical trial nested within a prospective cohort study. SCAMP will enroll 500 patients with musculoskeletal pain of the low back, hip or knee. Of these, half will have clinically significant depression and half will be nondepressed. The 250 depressed patients will be randomized to either stepped care or usual care. The stepped care group will receive 12 weeks of guideline concordant antidepressant treatment (step 1) administered by a Depression Pain Clinical Specialist (DPCS) nurse case manager. Patients not achieving adequate pain or global improvement after 12 weeks will receive a series of 6 manualized, evidence-based pain self-management sessions (step 2) from the DPCS. The 250 depressed patients in the trial will undergo comprehensive outcome assessment at baseline, 1, 3, 6 and 12 months by interviewers blinded to treatment group, and the 250 nondepressed patients in the cohort will undergo a similar assessment at baseline, 3 and 12 months. Our principal aim is to test whether stepped care is more effective than usual care in improving the co-primary outcomes of depression and pain. Secondarily, we will test the intervention's impact on HRQL, pain beliefs and behaviors, and health care costs. Longitudinal assessment of the nondepressed cohort will establish the frequency and risk factors for incident depression.