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 泌尿系慢性盆腔疼痛综合征（UCPPS）包括几种常见的，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， 不被理解，不被充分对待。他们长期的个人和经济成本被放大， 一组集中性疼痛疾病（特别是肠易激综合征3 [IBS]）的频繁并发症 还包括纤维肌痛[FMS]、慢性头痛、慢性疲劳等）叫做慢性重叠疼痛 （COPC）。在临床上，这些综合征共享一个集中的疼痛表型与一个基本的 疼痛或感觉处理障碍与我们的初步研究表明，一种新的 transdiagnosis行为治疗强调单一的共同机制途径（即僵化的认知 风格）降低了靶向（IBS）和非靶向多症状COPC的严重程度，包括（但不限于 UCPPS、FMS、慢性疲劳和慢性头痛。如果在更大规模的研究中有效， UCPPS治疗将提供一种更有效、更容易获得和更广泛有用的策略， 盆腔疼痛及其最常见和最复杂的合并症。为此，我们将随机抽取240个UCPPS 受试者（18-70岁）任何性别和种族的CBT的4个会话版本，教自我管理的技能 UCPPS症状（例如骨盆疼痛、泌尿系统症状），临床医生最小限度的疏忽（MC-CBT）或4- 会话非特定教育/支持控制（EDU）。疗效评估将在治疗前进行。 治疗结束后两周和10周急性期结束后两周。我们假设MC-CBT可以 UCPPS症状改善显著大于EDU（目标1）。其他目标包括表征 治疗后3个月和6个月的效果持久性（目标2）。为了提高效率和效率， 行为疼痛治疗，我们借鉴贝克的transdiagnosis认知模型13来描述精确的 认知过程和相应的操作过程（例如，认知距离14，上下文敏感性， 应对灵活性、重复的负面想法），推动MC-CBT诱导UCPPS症状相对于EDU缓解 (Aim 3）以及缓和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是个性化医疗目标的基础。通过应用 针对研究目的的创新统计建模（如优势分析、随机验证性试验分析） 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和共聚合COPC包括一个简洁，方便，和transdiagnostic设计 “满足患者的需求“20，并解决了实际（访问，复杂性，成本），临床（广度， 持久性、效应程度、患者偏好）和概念（非靶向合并症、非疼痛躯体 症状）的挑战，阻碍了基于证据的行为疼痛的吸收和公共卫生影响 在我们最脆弱的高冲击疼痛患者最需要的时候进行治疗。