Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome

摘要： 这项职业发展K23奖将确立我作为临床医生-研究员的地位，专注于 间质的循证心理社会治疗的发展、评估和传播 膀胱炎/膀胱痛综合征及相关疼痛综合征。我的建议以四个阶段的发展为目标 主要领域：1)临床试验的实施，2)疼痛机制和 用于检查患者表型的心理物理测试，3)先进的定量方法和4) 间质性膀胱炎/膀胱痛综合征(IC/BPS)的高级临床专业知识。要实现这些目标 目标，我已经组建了一个多学科的指导团队，与国际公认的 在疼痛、泌尿系统疾病和心理物理方面的临床试验、心理社会干预方面的经验 测试。间质性膀胱炎/膀胱痛综合征(IC/BPS)是一种使人虚弱、无法治愈且代价高昂的疼痛 这种疾病在美国影响着大约300万到800万人，并且极其严重 很难治疗。有证据表明，心理社会因素伴随并加剧了这种疾病。 未解决的心理社会共病与功能减退和较差有关 结果，这表明心理社会症状和膀胱特异性症状相互加强 其他的。虽然心理社会自我管理干预已经证明对其他疼痛有效 条件，IC/BPS领域缺乏黄金标准-随机对照试验-研究这些 干预措施。与此同时，慢性疼痛领域正在采用一种新的方法，由 疾病和治疗的机制。越来越多的证据表明，亚群(称为 IC/BPS患者对医疗干预的反应不同。中环现身 致敏(CS)在很大程度上定义了患者亚群，并可能是影响反应的生物学因素 去接受治疗。该项目的总体目标是充分开发、优化和评估 针对IC/BPS的以患者为中心的CBT自我管理干预。为了实现这一目标，我们将 开发(目标1)和测试(目标2)以经验为基础的IC/BPS心理社会治疗 注意力控制，同时检查疼痛机制和可能改变的亚组特征 治疗反应(目标3)。我们假设a)纳入自我管理干预将 对IC/BPS的治疗比对照治疗更有效，且b)治疗效果将有所缓和 根据心理并存的程度，存在慢性重叠的疼痛状况，以及 中枢敏感度升高。这些目标的成功完成将决定是否增加 对IC/BPS进行量身定制的自我管理干预与对照相比将改善结果， 是否特定的亚群对这种干预更有反应，以及生物学上的 机制(CS)影响治疗反应。这一职业发展奖将确保 我处于有利地位，可以进行一项大型临床试验，我们设想在2022年提交R01。

ABSTRACT: This career development K23 award will establish me as a clinician-investigator focused on the development, evaluation, and dissemination of evidence-based psychosocial treatment for interstitial cystitis/bladder pain syndrome and related pain syndromes. My proposal targets development in four primary areas: 1) implementation of clinical trials, 2) content expertise in pain mechanisms and psychophysical testing to examine patient phenotype, 3) advanced quantitative methods and 4) advanced clinical expertise in interstitial cystitis/bladder pain syndrome (IC/BPS). To achieve these goals, I have assembled a multidisciplinary mentorship team with internationally-recognized experience in clinical trials, psychosocial intervention in pain, urologic disease, and psychophysical testing. Interstitial cystitis/bladder pain syndrome (IC/BPS) is a debilitating, incurable, and costly pain condition affecting approximately 3-8 million individuals in the United States and is extremely challenging to treat. Evidence suggests psychosocial factors accompany and intensify the illness. Unaddressed psychosocial co-morbidities are associated with reduced functionality and poorer outcomes, which suggests that psychosocial symptoms and bladder-specific symptoms reinforce each other. While psychosocial self-management interventions have demonstrated efficacy for other pain conditions, the IC/BPS field lacks the gold standard – randomized controlled trials – studying these interventions. At the same time, the chronic pain field is adopting a new approach driven by mechanisms of illness and treatment. Growing evidence suggests that subgroups (called “phenotypes”) of patients with IC/BPS respond differently to medical intervention. Presence of central sensitization (CS) largely defines patient subgroups and may be a biological factor affecting response to medical treatment. The overall goal of this project is to fully develop, optimize, and evaluate a patient-centered CBT self-management intervention specific to IC/BPS. To achieve this goal, we will develop (Aim 1) and test (Aim 2) an empirically-based psychosocial treatment for IC/BPS compared to attention control, while examining pain mechanisms and subgroup characteristics that may alter treatment response (Aim 3). We hypothesize that a) inclusion of a self-management intervention will be more effective than a control treatment for IC/BPS, and that b) treatment effects will be moderated by degree of psychological co-morbidity, presence of chronic overlapping pain conditions, and elevated central sensitization. Successful completion of these aims will determine whether the addition of a tailored self-management intervention for IC/BPS will improve outcomes compared to control, whether particular subgroups are more responsive to this intervention, and whether a biological mechanism (CS) influences treatment responsiveness. This career development award will assure that I am well-positioned to conduct a large clinical trial that we envision as an R01 submission in 2022.