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Keywords:

  • Clinical Trial;
  • Geriatrics;
  • Depression;
  • Back Pain;
  • Survival Analysis

Abstract

Objective.  To describe the methodology of the first NIH-funded clinical trial for seniors with comorbid depression and chronic low back pain.

Methods.  Randomized 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.

Results.  Not applicable.

Conclusions.  The results of this trial will inform the care of these complex patients and further understanding of comorbid pain and depression in late life.