CONTEXT: Pain and depression are the most common physical and psychological symptoms in primary care, respectively. Moreover, they co-occur 30% to 50% of the time and have adverse effects on quality of life, disability, and health care costs. OBJECTIVE: To determine if a combined pharmacological and behavioral intervention improves both depression and pain in primary care patients with musculoskeletal pain and comorbid depression. DESIGN, SETTING, AND PATIENTS: Randomized controlled trial (Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP)) conducted at 6 community-based clinics and 5 Veterans Affairs general medicine clinics in Indianapolis, Indiana. Recruitment occurred from January 2005 to June 2007 and follow-up concluded in June 2008. The 250 patients had low back, hip, or knee pain for 3 months or longer and at least moderate depression severity (Patient Health Questionnaire 9 score >= 10). INTERVENTION: Patients were randomly assigned to the intervention (n = 123) or to usual care (n = 127). The intervention consisted of 12 weeks of optimized antidepressant therapy (step 1) followed by 6 sessions of a pain self-management program over 12 weeks (step 2), and a continuation phase of therapy for 6 months (step 3). MAIN OUTCOME MEASURES: Depression (20-item Hopkins Symptom Checklist), pain severity and interference (Brief Pain Inventory), and global improvement in pain at 12 months. RESULTS: At 12 months, 46 of the 123 intervention patients (37.4%) had a 50% or greater reduction in depression severity from baseline compared with 21 of 127 usual care patients (16.5%) (relative risk (RR) 2.3; 95% confidence interval (CI) 1.5 to 3.2), corresponding to a much lower number of patients with major depression (50 (40.7%) versus 87 (68.5%), respectively; RR 0.6 (95% CI 0.4 to 0.8)). Also, a clinically significant (>= 30%) reduction in pain was much more likely in intervention patients (51 intervention patients (41.5%) versus 22 usual care patients (17.3%); RR 2.4 (95% CI 1.6 to 3.2)), as was global improvement in pain (58 (47.2%) versus 16 (12.6%), respectively; RR 3.7 (95% CI 2.3 to 6.1)). More intervention patients also experienced benefits in terms of the primary outcome, which was a combined improvement in both depression and pain (32 intervention patients (26.0%) versus 10 usual care patients (7.9%); RR 3.3 (95% CI 1.8 to 5.4)). CONCLUSION: Optimized antidepressant therapy followed by a pain self-management program resulted in substantial improvement in depression as well as moderate reductions in pain severity and disability. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00118430.

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