A BRIEF, TRANSDIAGNOSTIC COGNITIVE BEHAVIORAL TREATMENT FOR UROLOGIC CHRONIC PELVIC PAIN SYNDROME (UCPPS): PROCESS, PREDICTIONS, OUTCOMES

泌尿系统慢性盆腔疼痛综合征 (UCPPS) 的简短跨诊断认知行为治疗：过程、预测、结果

• 批准号: 10680441
• 负责人: JEFFREY M LACKNER
• 金额: $ 65.3万
• 依托单位: STATE UNIVERSITY OF NEW YORK AT BUFFALO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-21 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10680441
• 关键词: Acute; Address; Affect; Aftercare; Behavior Therapy; Behavioral; Behavioral trial; COVID-19; Chronic; Chronic Headaches; Chronic Prostatitis; Clinical; Cognition; Cognitive; Cognitive Science; Cognitive Therapy; Development; Diagnosis; Diagnostic; Disease; Distress; Education; Educational process of instructing; Evidence based treatment; Fatigue; Fibromyalgia; Foundations; Gender; Goals; Health; Impairment; Increased frequency of micturition; Individual; Informal Social Control; Interstitial Cystitis; Irritable Bowel Syndrome; Laboratories; Learning; Length; Maps; Mediating; Mediator; Mission; Modeling; National Institute of Diabetes and Digestive and Kidney Diseases; Outcome; Pain; Pain management; Pathway interactions; Patient Preferences; Patients; Pelvic Pain; Phase; Phenotype; Policy Maker; Practice Guidelines; Procedures; Process; Provider; Public Health; Race; Randomized; Research; Research Personnel; Resources; Safety; Self Management; Sensory; Severities; Specificity; Statistical Models; Symptoms; Syndrome; Techniques; Testing; Time; United States National Institutes of Health; Woman; Work; arm; central pain; chronic pelvic pain; cognitive process; comorbidity; coping; cost; design; economic cost; efficacy evaluation; endophenotype; evidence base; flexibility; functional disability; health related quality of life; improved; innovation; interdisciplinary approach; men; non-drug; novel; novel therapeutics; pain catastrophizing; pain patient; patient engagement; patient variability; persistent symptom; personalized medicine; primary endpoint; prognostic indicator; provider adoption; reduce symptoms; response; secondary endpoint; skills; social; symptom self management; symptomatic improvement; trait; treatment effect; treatment optimization; uptake; urinary; urologic chronic pelvic pain syndrome

Abstract/Project Summary Urologic chronic pelvic pain syndrome (UCPPS) encompasses several common, costly diagnoses including interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome that are poorly understood and inadequately treated. Their prolonged personal and economic costs are amplified by the frequent co-occurrence of a cluster of centralized pain conditions (particularly irritable bowel syndrome 3 [IBS]) but also fibromyalgia [FMS], chronic headache, chronic fatigue, etc.) called Chronic Overlapping Pain Conditions (COPC). Clinically, the notion that these syndromes share a centralized pain phenotype with a fundamental disturbance in pain or sensory processing dovetails with our preliminary research showing that a novel transdiagnostic behavioral treatment emphasizing a single common mechanistic pathway (i.e. inflexible cognitive style) reduces severity of both targeted (IBS) and untargeted multisymptom COPCs that include (but is not limited to) to UCPPS, FMS, chronic fatigue, and chronic headache. If effective in a larger scale study, a transdiagnostic UCPPS treatment would offer a more efficient, accessible, and broadly useful strategy for improving chronic pelvic pain and its most frequent and complicating comorbidities. To this end, we will randomize 240 UCPPS subjects (18-70 yrs.) of any gender and race to a 4-session version of CBT that teaches skills for self-managing UCPPS symptoms (e.g. pelvic pain, urinary symptoms) with minimal clinician oversight (MC-CBT) or a four- session non-specific education/support control (EDU). Efficacy assessments will be administered at pre- treatment and two weeks after the end of the 10-week acute phase. We hypothesize MC-CBT will deliver significantly greater UCPPS symptom improvement than EDU (Aim 1). Additional aims include characterizing the durability of effects 3- and 6 months post treatment (Aim 2). To increase the efficacy and efficiency of behavioral pain treatments, we draw upon Beck’s transdiagnostic cognitive model13 to characterize the precise cognitive procedures and corresponding operative processes (e.g., cognitive distancing14, context sensitivity, coping flexibility, repetitive negative thought) that drive MC-CBT induced UCPPS symptom relief relative to EDU (Aim 3) as well as baseline patient variables that moderate differential response (Aim 3) with the ultimate goal of more proactive patient-treatment matching fundamental to the goals of personalized medicine. By applying innovative statistical modelling (e.g. dominance analysis, Randomized Explanatory Trial analyses) to study aims in the context of a rigorously designed behavioral trial, we expand the portfolio of nondrug pain treatments for UCPPS and co-aggregating COPCs to include one whose brevity, convenience, and transdiagnostic design “meets patients where they are”20 and addresses the practical (access, complexity, cost), clinical (breadth, durability, magnitude of effects, patient preference) and conceptual (untargeted comorbidities, non-pain somatic symptoms) challenges that have impeded uptake and public health impact of evidence-based behavioral pain treatments at a time when our most vulnerable high impact pain patients are in greatest need.

摘要/项目摘要 泌尿科慢性盆腔疼痛综合征 (UCPPS) 包括几种常见且昂贵的诊断，包括 间质性膀胱炎/膀胱疼痛综合征和慢性前列腺炎/慢性盆腔疼痛综合征效果不佳 他们的长期个人和经济成本被放大。 一系列集中性疼痛症状频繁同时发生（特别是肠易激综合征 3 [IBS]） 还有纤维肌痛 [FMS]、慢性头痛、慢性疲劳等）称为慢性重叠疼痛病症 (COPC) 临床上，这些综合征具有共同的集中疼痛表型和基本原理。 疼痛或感觉处理障碍与我们的初步研究相吻合，表明一种新颖的 跨诊断行为治疗强调单一的共同机制途径（即不灵活的认知 风格）降低了目标（IBS）和非目标多症状 COPC 的严重程度，包括（但不限于 到）UCPS、FMS、慢性疲劳和慢性头痛 如果在更大规模的研究中有效，则进行跨诊断。 UCPPS 治疗将为改善慢性病提供更有效、更容易、更广泛有用的策略。 为此，我们将随机分配 240 名 UCPPS。 任何性别和种族的受试者（18-70 岁）都可以参加 4 节的 CBT 版本，教授自我管理技能 UCPPS 症状（例如骨盆疼痛、泌尿系统症状），且临床医生监督程度最低 (MC-CBT) 或四- 会议非特定教育/支持控制（EDU）将在会议前进行。 治疗结束后两周，为期 10 周的急性期我们勇敢地进行了 MC-CBT。 与 EDU 相比，UCPS 症状显着改善（目标 1）。 治疗后 3 个月和 6 个月效果的持久性（目标 2）。 在行为疼痛治疗中，我们利用贝克的跨诊断认知模型13来描述精确的行为疼痛治疗 认知程序和相应的操作过程（例如，认知距离14、情境敏感性、 相对于 EDU 而言，MC-CBT 能够缓解 UCPPS 症状 （目标 3）以及调节差异反应的基线患者变量（目标 3），最终目标是 更积极主动的患者治疗匹配对于个性化医疗的目标至关重要。 用于研究目标的创新统计模型（例如优势分析、随机解释性试验分析） 在严格设计的行为试验的背景下，我们扩大了非药物疼痛治疗的组合 UCPPS 和共同聚合 COPC 包括一种简洁、方便和跨诊断设计 “满足患者所在的情况”20 并解决实际（获取、复杂性、成本）、临床（广度、 持久性、影响程度、患者偏好）和概念性（非目标合并症、非疼痛躯体疾病） 症状）阻碍基于证据的行为疼痛的接受和公共卫生影响的挑战 当我们最脆弱的高冲击疼痛患者最需要治疗时。