Psychosocial Treatment Development for Depression with Comorbid Chronic Pain

描述（由申请人提供）：抑郁症是一个大的公共卫生问题，在过去的一年中，超过6.6%的成年人经历了重度抑郁症（MDD）和相关损害的发作。大约40%的MDD患者也会经历慢性疼痛。除了MDD之外，还有慢性疼痛会导致残疾增加，医疗保健费用增加，相对于单独的MDD，抑郁缓解的机会减少。此外，抑郁症治疗对慢性疼痛患者的效果较差。抑郁和疼痛是寻求初级保健的最常见原因之一，接受这些问题治疗的很大一部分人将从普通医疗提供者那里获得治疗。尽管抑郁症与慢性疼痛共病的患病率和不良结局，相对较少的研究已经检查了治疗抑郁症和慢性疼痛的初级保健患者抑郁症的最佳方法，并且没有专门针对这些共病条件的心理治疗。拟议的治疗开发项目的目的是：1）开发一种基于理论的、协作的、针对抑郁症的心理治疗干预，特别是针对患有MDD和慢性腰痛共病的初级保健患者;和2）为最终的随机临床试验确定研究设计的可行性和可接受性，该试验将测试新开发治疗与对照治疗相比的疗效条件和先前建立的抑郁症治疗（认知疗法）。新的干预措施将整合并建立在抑郁症的行为疗法和慢性疼痛的行为疗法的基础上，以减少与这两个问题相关的行为回避为主要目标。该计划名为“情绪和身体疼痛计划”（PEPP），将包括由患者、初级保健提供者（PCP）和行为健康专家（BHS）参加的2次联席会议，以及患者和BHS在初级保健场所的10次单独访视。BHS将与PCP合作，提供协作行为健康护理。PEPP的设计将建立在常规护理的基础上。拟定的开发工作将在两项临床试验的背景下进行：1）PEPP的开放试验（n = 24），主要目标是开发和完善PEPP; 2）初步随机临床试验（n = 30），目的是证明RCT研究设计和各种治疗组的可行性和可接受性，并显示PEPP与对照条件不同。试验性RCT将包括3个治疗组：1）PEPP; 2）抑郁症认知疗法+“咨询和管理”（C & M）; 3）单独C & M。注意C & M基本上是像往常一样的治疗，有一些小的增强。在当前项目完成后，我们计划申请R01进行全功率RCT，其设计可能与当前项目中的试点RCT相同。在大规模随机对照试验中，抑郁严重程度将是主要结局，疼痛严重程度、身体和心理社会功能以及治疗满意度将是次要结局。行为激活、疼痛恐惧和疼痛灾难化将作为潜在的介质进行检查。 公共卫生相关性：据信，美国约有500万成年人目前患有重度抑郁症和慢性脊柱疼痛，其中下背部是最常见的慢性疼痛部位。重度抑郁症与严重的残疾和医疗保健费用有关，当慢性腰痛也存在时，这种对个人和社会的影响会增加。我们寻求开发一种针对抑郁症的协作心理治疗计划，该计划专门设计用于满足患有重度抑郁症和慢性腰痛的初级保健患者的需求。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: 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.