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Randomized Controlled Trial
. 2012 Mar;13(3):405-18.
doi: 10.1111/j.1526-4637.2011.01322.x. Epub 2012 Feb 7.

Addressing both depression and pain in late life: the methodology of the ADAPT study

Jordan F Karp  1 , Bruce L Rollman, Charles F Reynolds 3rd, Jennifer Q Morse, Frank Lotrich, Sati Mazumdar, Natalia Morone, Debra K Weiner
Affiliations
Randomized Controlled Trial

Addressing both depression and pain in late life: the methodology of the ADAPT study

Jordan F Karp et al. Pain Med. 2012 Mar.

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.

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Conflict of interest statement

Potential Conflicts of Interest: Dr. Karp served on advisory boards for Eli Lilly and Theravance greater than one year ago. He has received medication supplies for investigator initiated research from Pfizer, Eli Lilly, and Reckitt Bensicker. 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.

Figures

Figure 1
Figure 1
Study Design
Figure 2
Figure 2
Electronic Medical Record Recruitment Reminder for Physicians
See this image and copyright information in PMC

References

    1. Reid MC, Williams CS, Concato J, Tinetti ME, Gill TM. Depressive symptoms as a risk factor for disabling back pain in community-dwelling older persons. Journal of the American Geriatrics Society. 2003;51:1710–7. - PubMed
    1. Fishbain DA, Cutler R, Rosomoff HL, Rosomoff RS. Chronic pain-associated depression: antecedent or consequence of chronic pain? A review. Clinical Journal of Pain. 1997;13:116–37. - PubMed
    1. Rudy TE, Kerns RD, Turk DC. Chronic pain and depression: toward a cognitive-behavioral mediation model. Pain. 1988;35:129–40. - PubMed
    1. Lin EH, Katon W, Von Korff M, Tang L, Williams JW, Jr, Kroenke K, et al. Effect of improving depression care on pain and functional outcomes among older adults with arthritis: a randomized controlled trial.[see comment][comment] JAMA. 2003;290:2428–9. - PubMed
    1. Dunn KM, Croft PR. Classification of low back pain in primary care: using “bothersomeness” to identify the most severe cases. Spine. 2005;30:1887–92. - PubMed

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