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

基本信息

批准号：
10628729
负责人：
Lindsey Colman McKernan
金额：
$ 12.36万
依托单位：
VANDERBILT UNIVERSITY MEDICAL CENTER
依托单位国家：
美国
项目类别：
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/10628729
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

项目摘要

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.

抽象的：这项职业发展K23奖将使我成为一名专注于临床评估者基于证据的心理治疗的开发，评估和传播间隙膀胱炎/膀胱疼痛综合征和相关疼痛综合征。我的提议针对四个主要领域：1）实施临床试验，2）疼痛机制和心理物理测试检查患者表型，3）高级定量方法和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。实现这些目标，我已经组建了一个以国际认可的多学科心态团队在临床试验，疼痛，泌尿科疾病和心理物理的心理心理干预方面的经验测试。间质性膀胱炎/膀胱疼痛综合征（IC/BPS）是一种令人衰弱，无法治愈的疼痛在美国影响大约3-8万个人的状况，非常极端具有挑战性的治疗。有证据表明，涉及的社会心理因素并加剧了疾病。未解决的社会心理合并症与功能降低相关，较差结果，这表明社会心理症状和膀胱特异性症状加强了每种其他。虽然社会心理自我管理干预措施已经表现出其他痛苦的效率条件，IC/BPS领域缺乏黄金标准 - 随机对照试验 - 研究这些试验干预措施。同时，慢性疼痛领域正在采用一种新方法疾病和治疗机制。越来越多的证据表明亚组（称为 IC/BPS患者的“表型”对医疗干预的反应不同。中央的存在致敏（CS）在很大程度上定义了患者亚组，可能是影响反应的生物因素接受医疗。该项目的总体目标是完全开发，优化和评估以患者为中心的CBT自我管理干预特定于IC/BPS。为了实现这一目标，我们将与IC/BPS开发（AIM 1）和测试（AIM 2）对IC/BP的经验心理治疗注意控制，同时检查可能改变的疼痛机制和亚组特征治疗反应（目标3）。我们假设a）包括自我管理干预将比IC/BP的对照治疗更有效，并且B）治疗效果将受到调节根据心理合并症的程度，存在慢性重叠疼痛条件的存在以及中央灵敏度提高。成功完成这些目标将决定加法是否是否与对照相比特定的亚组是否对这种干预措施更敏感，以及生物学是否机制（CS）影响治疗反应能力。该职业发展奖将确保我很容易进行一项大型临床试验，我们将其视为2022年的R01提交。