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，每年就诊人数超过1亿。疼痛每年花费美国超过1000亿美元的医疗保健和生产力损失。三分之二的疼痛相关的医疗保健就诊与肌肉骨骼疼痛有关，其中腰部，臀部和膝盖是最常见的部位。研究一致表明，至少三分之一的疼痛患者患有伴随的抑郁症，并且共病的疼痛和抑郁症对疼痛特异性（即，疼痛和抑郁减轻）以及健康相关的生活质量（HRQL）结果。目前尚未确定的是，在初级保健中改善抑郁症结局的治疗策略是否对疼痛和抑郁症共病患者有效。因此，我们建议进行情感障碍和肌肉骨骼疼痛分级护理（SCAMP）研究，该研究设计为一项嵌套在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、髋关节或膝关节肌肉骨骼疼痛的患者。其中，一半将有临床显著的抑郁症，一半将是非抑郁症。250名抑郁症患者将被随机分配到阶梯式护理或常规护理组。分级护理组将接受由抑郁症疼痛临床专家（DPCS）护士病例经理给予的12周指南一致性抗抑郁药治疗（步骤1）。12周后未达到足够疼痛或整体改善的患者将接受DPCS的6次手动循证疼痛自我管理会议（第2步）。试验中的250名抑郁症患者将在基线、1、3、6和12个月时由对治疗组不知情的访问者进行全面的结局评估，队列中的250名非抑郁症患者将在基线、3和12个月时进行类似的评估。我们的主要目的是测试分级护理是否比常规护理更有效地改善抑郁症和疼痛的共同主要结局。其次，我们将测试干预措施对HRQL，疼痛信念和行为以及医疗保健费用的影响。对非抑郁症队列的纵向评估将确定抑郁症发生的频率和危险因素。

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.