Depression is a large public health concern with over 6.6% of adults experiencing an episode of major depressive disorder (MDD), and associated impairment, in the past year. Approximately 40% of individuals with MDD also experience chronic pain. Having chronic pain in addition to MDD results in increased disability, increased health care costs, and decreased chance of depression remission relative to having MDD alone. Furthermore, depression treatments are less effective in patients with chronic pain. Depression and pain are among the most frequent reasons for seeking primary care, and a large proportion of individuals who receive treatment for these problems will get their treatment from a general medical provider. Despite the prevalence and poor outcome of MDD with comorbid chronic pain, relatively little research has examined the best way to treat depression in primary care patients with MDD and chronic pain, and there is no psychotherapy specifically tailored for these comorbid conditions. The purpose of the proposed treatment development project is to 1) develop a theory-based, collaborative, psychotherapeutic intervention for depression specifically for primary care patients with MDD and comorbid chronic low back pain;and 2) establish the feasibility and acceptability of a research design for an eventual randomized clinical trial which would test the efficacy of the newly developed treatment in comparison to that of a control condition and of a previously established treatment for depression (cognitive therapy). The new intervention will integrate and build on behavior therapy for depression and behavioral therapy for chronic pain, towards a main target of reducing behavioral avoidance associated with both problems. This program, entitled Program for Emotional and Physical Pain (PEPP), will include 2 joint meetings, attended by the patient, the primary care provider (PCP), and the behavioral health specialist (BHS) and 10 individual visits between the patient and the BHS at the primary care site. The BHS will work with the PCP to provide collaborative behavioral health care. PEPP will be designed to build upon usual care. The proposed development work will occur in the context of two clinical trials: 1) an open trial of PEPP (n =24), with the primary goal of developing and refining PEPP;and 2) a pilot randomized clinical trial (n = 30), with the goals of demonstrating feasibility and acceptability of the RCT research design and various treatment arms, and showing that PEPP is differentiable from control conditions. The pilot RCT will consist of 3 treatment arms: 1) PEPP;2) cognitive therapy for depression + """"""""Consultation and Management"""""""" (C&M);and 3) C&M alone. Note C&M is essentially treatment as usual with some small enhancements. After completion of the current project, we plan to apply for an R01 to conduct a fully-powered RCT that will likely be of the same design as the pilot RCT in the current project. In the large scale RCT, depression severity will be the primary outcome and pain severity, physical and psychosocial functioning, and treatment satisfaction will be secondary outcomes. Behavioral activation, fear of pain, and pain catastrophizing will be examined as potential mediators.
Approximately 5 million adults in the U.S. are thought to currently suffer from both major depression and chronic spinal pain, with the low back being the most common chronic pain site. Major depression is associated with significant disability and health care costs, and this impact on both the individual and society is increased when chronic low back pain is also present. We seek to develop a collaborative psychotherapy program for depression that is specifically designed to meet the needs of primary care patients with both major depression and chronic low back pain.
