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A Randomized Controlled Trial

Kurt Kroenke, MD; Matthew J. Bair, MD, MS; Teresa M. Damush, PhD; Jingwei Wu, MS; Shawn Hoke, BA; Jason Sutherland, PhD; Wanzhu Tu, PhD

JAMA. 2009;301(20):2099-2110.

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], 1.5-3.2), 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 (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]).

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

Author Affiliations: Divisions of General Internal Medicine and Geriatrics (Drs Kroenke, Bair, and Damush) and Biostatistics (Mr Wu and Dr Tu), Indiana University School of Medicine, Indianapolis; VA HSR&D Center of Excellence on Implementation of Evidence-Based Practices, Roudebush VAMC, Indianapolis, Indiana (Drs Bair and Damush and Mr Hoke); Regenstrief Institute Inc, Indianapolis, Indiana (Drs Kroenke, Bair, Damush, Tu and Mr Hoke); and the Dartmouth Institute for Health Policy and Clinical Practice, Hanover, New Hampshire (Dr Sutherland).

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