A BRIEF, TRANSDIAGNOSTIC COGNITIVE BEHAVIORAL TREATMENT FOR UROLOGIC CHRONIC PELVIC PAIN SYNDROME (UCPPS): PROCESS, PREDICTIONS, OUTCOMES
A BRIEF, TRANSDIAGNOSTIC COGNITIVE BEHAVIORAL TREATMENT FOR UROLOGIC CHRONIC PELVIC PAIN SYNDROME (UCPPS): PROCESS, PREDICTIONS, OUTCOMES
批准号:
10366390
负责人:
JEFFREY M LACKNER
金额:
$71.72万
依托单位国家:
美国
项目类别:
财政年份:
2021
资助国家:
美国
项目状态:
未结题
起止时间:
2021-09-21 至 2026-07-31
关键词:
AcuteAddressAffectAftercareBehavior TherapyBehavioralBehavioral trialCOVID-19ChronicChronic HeadachesChronic ProstatitisClinicalCognitionCognitiveCognitive ScienceCognitive TherapyDevelopmentDiagnosisDiseaseDistressEducationEvidence based treatmentFatigueFibromyalgiaFoundationsGenderGoalsHealthImpairmentIncreased frequency of micturitionIndividualInformal Social ControlInterstitial CystitisIrritable Bowel SyndromeLaboratoriesLearningLengthMediatingMediator of activation proteinMissionNational Institute of Diabetes and Digestive and Kidney DiseasesOutcomePainPain managementPathway interactionsPatient PreferencesPatientsPelvic PainPhasePhenotypePolicy MakerPractice GuidelinesProceduresProcessPrognostic MarkerProviderPublic HealthRaceRandomizedResearchResearch PersonnelResourcesSafetySelf ManagementSensorySeveritiesSpecificityStatistical ModelsSymptomsSyndromeTechniquesTestingTimeUnited States National Institutes of HealthWomanWorkarmbasecentral painchronic pelvic paincognitive processcomorbiditycopingcostdesigneconomic costefficacy evaluationendophenotypeevidence baseflexibilityfunctional disabilityhealth related quality of lifeimprovedinnovationinterdisciplinary approachmennon-drugnovelnovel therapeuticspain catastrophizingpain patientpatient engagementpersistent symptompersonalized medicineprimary endpointprovider adoptionreduce symptomsresponsesecondary endpointskillssocialsymptom self managementsymptomatic improvementtraittreatment effecttreatment optimizationuptakeurinaryurologic chronic pelvic pain syndrome
中文摘要
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/膀胱痛综合征和慢性前列腺炎/慢性盆腔疼痛综合征较差
被理解并且没有得到充分的对待。他们长期的个人和经济成本被放大了
经常同时出现一系列集中疼痛症状(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。)称为慢性重叠疼痛状况
(COPC)。临床上,这些症状具有集中的疼痛表型和基本的
疼痛或感觉处理的障碍与我们的初步研究相吻合,表明一种新的
强调单一共同机制途径(即僵化的认知)的跨诊断行为疗法
风格)可降低靶向(IBS)和非靶向多症状COPC的严重程度,包括(但不限于
至)UCPPS、FMS、慢性疲劳和慢性头痛。如果在更大规模的研究中有效,跨诊断
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来改善慢性
盆腔疼痛及其最常见和最复杂的合并症。为此,我们将随机选择240个UCPPS
受试者(18-70岁)不分性别和种族参加为期4节的CBT课程,教授自我管理的技能
UCPPS症状(例如骨盆疼痛、尿路症状)和最低限度的临床医生监督(MC-CBT)或4-
会议非特定教育/支持控制(EDU)。疗效评估将在
治疗和为期10周的急性期结束后两周。我们假设MC-CBT将交付
UCPPS症状改善明显优于EDU(目标1)。其他目标包括刻画
治疗后3个月和6个月效果的持久性(目标2)。提高……的效力和效率
行为疼痛治疗,我们借鉴贝克的跨诊断认知模型13来描述
认知过程和相应的操作过程(例如,认知距离14,语境敏感性,
应对灵活性、重复的负面思维),促使MC-CBT导致UCPPS症状相对于EDU的缓解
(目标3)以及适度差异反应的基线患者变量(目标3),最终目标为
更加积极主动的患者治疗匹配,基本符合个性化医疗的目标。通过应用
创新统计建模(例如优势分析、随机解释性试验分析)以研究目标
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,包括其简洁、方便和跨诊断设计
20并解决了实用性(接入、复杂性、成本)、临床(广度、
持久性、效果大小、患者偏好)和概念性(非靶向共病、非疼痛躯体
症状)阻碍了循证行为疼痛的接受和公共健康影响的挑战
在我们最脆弱的高冲击性疼痛患者最需要治疗的时候进行治疗。
英文摘要
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.
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会议论文
A BRIEF, TRANSDIAGNOSTIC COGNITIVE BEHAVIORAL TREATMENT FOR UROLOGIC CHRONIC PELVIC PAIN SYNDROME (UCPPS): PROCESS, PREDICTIONS, OUTCOMES
-
批准号:10680441
-
项目类别:
-
资助金额:$65.3万
-
财政年份:2021
-
负责人:JEFFREY M LACKNER
-
依托单位:
A BRIEF, TRANSDIAGNOSTIC COGNITIVE BEHAVIORAL TREATMENT FOR UROLOGIC CHRONIC PELVIC PAIN SYNDROME (UCPPS): PROCESS, PREDICTIONS, OUTCOMES
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批准号:10491127
-
项目类别:
-
资助金额:$67.65万
-
财政年份:2021
-
负责人:JEFFREY M LACKNER
-
依托单位:
Neurobiological mechanisms underlying effectiveness of CBT in IBS patients
-
批准号:8731871
-
项目类别:
-
资助金额:$51.87万
-
财政年份:2012
-
负责人:JEFFREY M LACKNER
-
依托单位:
Neurobiological mechanisms underlying effectiveness of CBT in IBS patients
-
批准号:8386876
-
项目类别:
-
资助金额:$54.57万
-
财政年份:2012
-
负责人:JEFFREY M LACKNER
-
依托单位:
Neurobiological mechanisms underlying effectiveness of CBT in IBS patients
-
批准号:8542837
-
项目类别:
-
资助金额:$50.05万
-
财政年份:2012
-
负责人:JEFFREY M LACKNER
-
依托单位:
Self-Administered CBT for IBS: A Multicenter Trial
-
批准号:8011855
-
项目类别:
-
资助金额:$18.19万
-
财政年份:2010
-
负责人:JEFFREY M LACKNER
-
依托单位:
Self-Administered CBT for IBS: A Multicenter Trial
-
批准号:8255550
-
项目类别:
-
资助金额:$118.66万
-
财政年份:2008
-
负责人:JEFFREY M LACKNER
-
依托单位:
Self-Administered CBT for IBS: A Multicenter Trial
-
批准号:8105085
-
项目类别:
-
资助金额:$127.96万
-
财政年份:2008
-
负责人:JEFFREY M LACKNER
-
依托单位:
Self-Administered CBT for IBS: A Multicenter Trial
-
批准号:7621016
-
项目类别:
-
资助金额:$125.71万
-
财政年份:2008
-
负责人:JEFFREY M LACKNER
-
依托单位:
Self-Administered CBT for IBS: A Multicenter Trial
-
批准号:8547240
-
项目类别:
-
资助金额:$1.8万
-
财政年份:2008
-
负责人:JEFFREY M LACKNER
-
依托单位:
Self-Administered CBT for IBS: A Multicenter Trial
-
批准号:7388349
-
项目类别:
-
资助金额:$66.75万
-
财政年份:2008
-
负责人:JEFFREY M LACKNER
-
依托单位:
Self-Administered CBT for IBS: A Multicenter Trial
-
批准号:8546336
-
项目类别:
-
资助金额:$127.07万
-
财政年份:2008
-
负责人:JEFFREY M LACKNER
-
依托单位:
Self-Administered CBT for IBS: A Multicenter Trial
-
批准号:7846740
-
项目类别:
-
资助金额:$124.04万
-
财政年份:2008
-
负责人:JEFFREY M LACKNER
-
依托单位:
Self-Administered CBT for IBS: A Multicenter Trial
-
批准号:8731863
-
项目类别:
-
资助金额:$103.26万
-
财政年份:2008
-
负责人:JEFFREY M LACKNER
-
依托单位:
Development of limited contact CBT treatment for IBS
-
批准号:6912645
-
项目类别:
-
资助金额:$15.7万
-
财政年份:2004
-
负责人:JEFFREY M LACKNER
-
依托单位:
Development of limited contact CBT treatment for IBS
-
批准号:6806878
-
项目类别:
-
资助金额:$15.7万
-
财政年份:2004
-
负责人:JEFFREY M LACKNER
-
依托单位:
海外基金