Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome

优化间质性膀胱炎/膀胱疼痛综合征的心理社会治疗

• 批准号: 10380630
• 负责人: Lindsey Colman McKernan
• 金额: $ 18.54万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-13 至 2024-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10380630
• 关键词: Adopted; Affect; American; Anxiety; Area; Behavioral; Biological; Biological Factors; Bladder; Characteristics; Chronic; Clinical; Clinical Trials; Cognitive; Collaborations; Data; Depression and Suicide; Development; Development Plans; Disease; Distress; Emotional; Evaluation; Exhibits; Expert Opinion; Floor; Focus Groups; Genitourinary system; Goals; Gold; Increased frequency of micturition; Individual; International; Interstitial Cystitis; Intervention; Intervention Studies; K-Series Research Career Programs; Learning; Mediating; Medical; Mental Depression; Mentored Patient-Oriented Research Career Development Award; Mentorship; Methods; National Institute of Diabetes and Digestive and Kidney Diseases; Outcome; Outcomes Research; Pain; Panic; Participant; Patient-Focused Outcomes; Patients; Pelvic Pain; Pelvis; Persons; Phenotype; Positioning Attribute; Principal Investigator; Psychophysics; Psychosocial Factor; Quality of life; Randomized Controlled Trials; Recommendation; Reporting; Research; Research Personnel; Research Support; Self Management; Sex Functioning; Strategic Planning; Subgroup; Symptoms; Syndrome; Testing; Time; Treatment Efficacy; United States; Urologic Diseases; Work; attentional control; base; career development; central sensitization; chronic pain; chronic painful condition; clinical trial implementation; comorbidity; compare effectiveness; cost; design; evidence base; experience; external genitalia; improved; improved outcome; interdisciplinary approach; micturition urgency; multidisciplinary; novel strategies; pain outcome; pain processing; patient oriented; patient subsets; physical symptom; pressure; primary outcome; psychologic; psychosocial; response; secondary outcome; standard care; stress management; therapy design; treatment effect; treatment guidelines; treatment response; urinary; urologic

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.

摘要： 这个职业发展K23奖将使我成为一名专注于 发展、评估和传播基于证据的间质性疾病的社会心理治疗 膀胱炎/膀胱疼痛综合征和相关疼痛综合征。我的建议目标是在四个 主要领域：1）临床试验的实施，2）疼痛机制的内容专业知识， 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/膀胱疼痛综合征（IC/BPS）的高级临床专业知识。实现这些 为了实现目标，我组建了一个多学科的导师团队， 临床试验经验，疼痛、泌尿系统疾病和心理物理的心理社会干预 试验.间质性膀胱炎/膀胱疼痛综合征（IC/BPS）是一种使人衰弱、无法治愈且代价高昂的疼痛 在美国，这种情况影响了大约300万至800万人， 有证据表明，心理社会因素伴随并加剧了这种疾病。 未得到解决的心理社会共病与功能降低和更差相关。 结果，这表明，心理社会症状和膀胱特异性症状加强每一个 其他.虽然心理社会自我管理干预已证明对其他疼痛有效， 条件下，IC/BPS领域缺乏金标准-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， 疾病和治疗的机制。越来越多的证据表明， IC/BPS患者对医疗干预的反应不同。存在中央 致敏（CS）在很大程度上定义了患者亚组，可能是影响反应的生物学因素 接受治疗该项目的总体目标是全面开发、优化和评估一个 以患者为中心的CBT自我管理干预，针对IC/BPS。为了实现这一目标，我们将 开发（目标1）和测试（目标2）一种基于药物的IC/BPS心理社会治疗方法， 注意力控制，同时检查疼痛机制和亚组特征， 治疗反应（目标3）。我们假设a）纳入自我管理干预将 对于IC/BPS，比对照治疗更有效，并且B）治疗效果将被缓和 按心理共病程度、慢性重叠疼痛状况的存在，以及 中枢敏感性增强。能否成功实现这些目标将决定是否增加 与对照组相比，针对IC/BPS的量身定制的自我管理干预将改善结果， 是否特定的亚组对这种干预更敏感，以及生物学是否 机制（CS）影响治疗反应性。这个职业发展奖将确保， 我有能力进行一项大型临床试验，我们设想在2022年提交R 01。