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 ≥60years old. Phase 1 (6 weeks) is open treatment with venlafaxine xr 150mg/day and supportive management (SM). Response is 2weeks of PHQ-9 ≤5 and at least 30% improvement in the average numeric rating scale for pain. Nonresponders progress to phase 2 (14weeks) in which they are randomized to high-dose venlafaxine xr (up to 300mg/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.
Original language | English (US) |
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Pages (from-to) | 405-418 |
Number of pages | 14 |
Journal | Pain Medicine |
Volume | 13 |
Issue number | 3 |
DOIs | |
State | Published - Mar 2012 |
Externally published | Yes |
Keywords
- Back pain
- Clinical trial
- Depression
- Geriatrics
- Survival analysis
ASJC Scopus subject areas
- General Medicine