Open AccessAddressing Both Depression and Pain in Late Life: The Methodology of the ADAPT Study
Author(s) -
Karp Jordan F.,
Rollman Bruce L.,
Reynolds Charles F.,
Morse Jennifer Q.,
Lotrich Frank,
Mazumdar Sati,
Morone Natalia,
Weiner Debra K.
Publication year - 2012
Publication title -
pain medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.893
H-Index - 97
eISSN - 1526-4637
pISSN - 1526-2375
DOI - 10.1111/j.1526-4637.2011.01322.x
Subject(s) - venlafaxine , randomized controlled trial , depression (economics) , medicine , physical therapy , rating scale , clinical trial , chronic pain , psychiatry , psychology , anxiety , antidepressant , developmental psychology , macroeconomics , economics
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.