Optimized antidepressant therapy and pain self-management in primary care patients with depression and musculoskeletal pain: a randomized controlled trial.

contextPain 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.

objectiveTo 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 > or = 10).

interventionPatients 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 measuresDepression (20-item Hopkins Symptom Checklist), pain severity and interference (Brief Pain Inventory), and global improvement in pain at 12 months.

resultsAt 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], 1.5-3.2), corresponding to a much lower number of patients with major depression (50 [40.7%] vs 87 [68.5%], respectively; RR, 0.6 [95% CI, 0.4-0.8]). Also, a clinically significant (> or = 30%) reduction in pain was much more likely in intervention patients (51 intervention patients [41.5%] vs 22 usual care patients [17.3%]; RR, 2.4 [95% CI, 1.6-3.2]), as was global improvement in pain (58 [47.2%] vs 16 [12.6%], respectively; RR, 3.7 [95% CI, 2.3-6.1]). 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%] vs 10 usual care patients [7.9%]; RR, 3.3 [95% CI, 1.8-5.4]).

conclusionOptimized 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 registrationclinicaltrials.gov Identifier: NCT00118430.