Clinicaltrials.gov Trial Registration Identifier: NCT01124188.
Addressing Both Depression and Pain in Late Life: The Methodology of the ADAPT Study
Article first published online: 7 FEB 2012
Wiley Periodicals, Inc.
Volume 13, Issue 3, pages 405–418, March 2012
How to Cite
Karp, J. F., Rollman, B. L., Reynolds, C. F., Morse, J. Q., Lotrich, F., Mazumdar, S., Morone, N. and Weiner, D. K. (2012), Addressing Both Depression and Pain in Late Life: The Methodology of the ADAPT Study. Pain Medicine, 13: 405–418. doi: 10.1111/j.1526-4637.2011.01322.x
Supported by grant AG033575 (Karp) and by grant KL2 RR024154 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. The content is solely the responsibility of the authors and does not necessarily represent the official view of NCRR or NIH. Medications were provided by Pfizer for this investigator initiated trial.
Potential Conflicts of Interest: Dr. Karp served on advisory boards for Eli Lilly and Theravance greater than 1 year ago. He has received medication supplies for investigator initiated research from Pfizer, Eli Lilly, and Reckitt Benckiser. He owns stock in Corcept. Dr. Reynolds has received medication supplies for investigator initiated research from Eli Lilly, Pfizer, Forest, and Bristol Myers. The other authors do not declare any potential conflict of interest.
- Issue published online: 16 MAR 2012
- Article first published online: 7 FEB 2012
- Clinical Trial;
- Back Pain;
- Survival Analysis
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.