• Jordan F Karp, Bruce L Rollman, Charles F Reynolds, Jennifer Q Morse, Frank Lotrich, Sati Mazumdar, Natalia Morone, and Debra K Weiner.
• Departments of Psychiatry, University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA. karpjf@upmc.edu
• Pain Med. 2012 Mar 1; 13 (3): 405-18.

ObjectiveTo describe the methodology of the first NIH-funded clinical trial for seniors with comorbid depression and chronic low back pain.MethodsRandomized controlled effectiveness trial using stepped care methodology. Participants are ≥60 years old. Phase 1 (6 weeks) is open treatment with venlafaxine xr 150 mg/day and supportive management (SM). Response is 2 weeks of PHQ-9 ≤5 and at least 30% improvement in the average numeric rating scale for pain. Nonresponders progress to phase 2 (14 weeks) in which they are randomized to high-dose venlafaxine xr (up to 300 mg/day) with problem solving therapy for depression and pain (PST-DP) or high-dose venlafaxine xr and continued SM. Primary outcomes are the univariate pain and depression response and both observed and self-reported disability. Survival analytic techniques will be used, and the clinical effect size will be estimated with the number needed to treat. We hypothesize that self-efficacy for pain management will mediate response for subjects randomized to venlafaxine xr and PST-DP.ResultsNot applicable.ConclusionsThe results of this trial will inform the care of these complex patients and further understanding of comorbid pain and depression in late life.Wiley Periodicals, Inc.

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