Stepped Care for Depression and Musculoskeletal Pain

描述(由申请人提供)：疼痛是一种主诉，占美国所有初级保健就诊的近20%，每年就诊人数超过1亿人次。疼痛每年使美国在医疗保健和生产力方面损失超过1000亿美元。三分之二的疼痛相关医疗就诊与肌肉骨骼疼痛有关，其中腰背部、臀部和膝盖是最常见的部位。研究一直表明，至少有三分之一的疼痛患者患有伴随的抑郁，同时疼痛和抑郁对特定症状(即疼痛和抑郁的减轻)以及与健康相关的生活质量(HRQL)结果具有互惠的不利影响。尚不确定的是，初级保健中显示的改善抑郁症结果的治疗策略是否对合并疼痛和抑郁的患者有效。因此，我们建议进行情感障碍和肌肉骨骼疼痛的阶梯式护理(SCAMP)研究，设计为嵌套在前瞻性队列研究中的随机临床试验。SCAMP将招募500名腰背、臀部或膝盖肌肉骨骼疼痛的患者。在这些人中，一半将有临床上明显的抑郁症，另一半将不会抑郁。这250名抑郁症患者将被随机分为阶梯式护理和常规护理。阶梯式护理组将接受为期12周的指南一致的抗抑郁治疗(步骤1)，由抑郁疼痛临床专家(DPCS)护士病例经理实施。12周后疼痛没有得到充分改善或总体改善的患者将从DPCS获得一系列6次手动的、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个月时由观察者对治疗组进行全面的结果评估，而队列中的250名非抑郁症患者将在基线、3个月和12个月接受类似的评估。我们的主要目的是测试分级护理在改善抑郁症和疼痛的共同原发结局方面是否比常规护理更有效。其次，我们将测试干预对HRQL、疼痛信念和行为以及医疗成本的影响。对非抑郁队列的纵向评估将确定偶发抑郁的频率和风险因素。

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.