A Randomized Trial of a Web-based Non-Pharmacological Pain Intervention for Pediatric Chronic Pancreatitis

基于网络的非药物疼痛干预小儿慢性胰腺炎的随机试验

• 批准号: 10442428
• 负责人: Tonya M Palermo
• 金额: $ 54.2万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-15 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10442428
• 关键词: APOA5 gene; Abdominal Pain; Adolescent; Adult; Aftercare; Age; Behavioral; Biological Factors; CYP2C19 gene; CYP2D6 gene; CYP3A4 gene; CYP3A5 gene; Caring; Characteristics; Child; Child Health; Childhood; Clinical; Cognitive; Cognitive Therapy; Control Groups; Cystic Fibrosis Transmembrane Conductance Regulator; Development; Diagnosis; Disease; Double-Blind Method; Double-blind trial; Economic Burden; Economics; Education; Emergency department visit; Emotional; Exposure to; Family; Frequencies; Future; Genes; Genetic; Genetic Polymorphism; Genotype; Geography; Goals; HTR2A gene; Headache; Health; Health Services Accessibility; Hospitalization; Image; Inflammation; Interleukin-10; International; Internet; Intervention; Investigation; Knowledge; Measurable; Measures; Medical; Mental Depression; Musculoskeletal Pain; Online Systems; Operative Surgical Procedures; Opioid; Outcome; Outcome Study; Pain; Pain Research; Pain management; Pancreatitis; Parents; Participant; Patient Education; Patients; Pharmaceutical Preparations; Pharmacological Treatment; Phenotype; Physical Function; Placebo Control; Population; Prediction of Response to Therapy; Predictive Factor; Pseudogenes; Psychosocial Factor; Randomized; Randomized Controlled Trials; Reporting; Research; Research Design; Risk; SPINK1 gene; Sampling; Severities; Social Functioning; Testing; Time; Training; Variant; anxiety symptoms; base; behavioral phenotyping; chronic abdominal pain; chronic pain; chronic pain management; chronic pancreatitis; claudin-1 protein; clinical phenotype; cohort; cost; demographics; depressive symptoms; design; disability; drug metabolism; effective therapy; efficacy evaluation; emotional functioning; experience; family burden; flexibility; follow-up; genetic risk factor; health care service utilization; health related quality of life; improved; lipid metabolism; next generation sequencing; opioid exposure; opioid use; pain outcome; pain reduction; pain self-management; pain symptom; pain-related disability; pediatric patients; precision medicine; predicting response; prescription opioid; prevent; primary outcome; programs; psychologic; randomized trial; recruit; response; risk stratification; secondary outcome; treatment center; treatment duration; treatment response

Project Summary Abdominal pain is present in 81% of children and adolescents with chronic pancreatitis (CP). As pain becomes more frequent and severe, it results in measurable declines in the children's health and creates economic burden on families. Effective treatments that target pain in these children will lessen the risk of opioid exposure and continued pain and disability into adulthood. There is evidence that psychological treatments, principally cognitive-behavioral therapies (CBT), can decrease pain and disability in children. However, even when effective treatments have been validated, most children do not receive psychological intervention for chronic pain management due to barriers that prevent access to treatment such as lack of trained clinicians, and geographic distance to treatment centers. Alternative forms of treatment delivery through the Internet can overcome these barriers. We have already made significant progress in developing and evaluating an internet- delivered psychological intervention called Web-based Management of Adolescent Pain (WebMAP). Our findings from a multicenter randomized controlled trial indicated that children in families that received this intervention experienced significant improvements in pain-related disability, depression, and parent-perceived impact of pain compared to children receiving patient education alone. The proposed project is designed to apply our expertise in delivering Internet-based pain management programs to the largest cohort (INSPPIRE: INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) of well-phenotyped children with CP to reduce pain, pain-related disability, and enhance health-related quality of life. The overall hypothesis of this application is that web-based CBT will significantly improve pain, pain-related disability and HRQOL. We plan to recruit a large multicenter sample of 260 children and adolescents (ages 10-17 years) with CP and their parents from INSPPIRE centers to evaluate the efficacy of WebMAP. The study design is a two (group) x three (time point) randomized, controlled, double-blinded trial. Participants will be randomly assigned to receive online access to either patient education (WebED) or CBT (WebMAP) over an 8-10 week treatment period. The primary study outcome is pain-related disability measured at pre-treatment, immediately post-treatment, and at 6-month follow-up. Secondary outcomes include child reported pain, health-related quality of life, depression and anxiety symptoms, and medication use. We will also evaluate genetic polymorphisms, clinical, and behavioral phenotypic factors that predict treatment response. This project represents a significant advance in pain management for children with CP by evaluating the first ever non- pharmacologic pain intervention in these patients, which may guide future developments in the management of chronic pain associated with CP. The long-term goal of this research program is to develop effective and flexible treatments that can be delivered at low cost to reduce chronic abdominal pain and pain-related disability in children with CP.

项目摘要 81%的慢性胰腺炎(CP)儿童和青少年存在腹痛。当疼痛变成 更频繁和更严重的是，它会导致儿童健康明显下降，并创造经济 家庭的负担。针对这些儿童疼痛的有效治疗将降低阿片类药物暴露的风险 以及持续的疼痛和残疾，直到成年。有证据表明，心理治疗，主要是 认知行为疗法(CBT)可以减少儿童的疼痛和残疾。然而，即使当 有效的治疗方法已经得到验证，大多数儿童没有接受慢性心理干预 由于缺乏训练有素的临床医生等阻碍获得治疗的障碍而导致的疼痛管理，以及 到治疗中心的地理距离。通过互联网提供治疗的替代形式可以 克服这些障碍。我们在开发和评估互联网方面已经取得了重大进展- 提供心理干预，称为基于网络的青少年疼痛管理(WebMAP)。我们的 一项多中心随机对照试验的结果表明，接受这种治疗的家庭中的儿童 干预在疼痛相关的残疾、抑郁和父母感知方面有显著改善 与单独接受患者教育的儿童相比，疼痛的影响更大。拟议的项目旨在 将我们在提供基于互联网的疼痛管理计划方面的专业知识应用于最大的队列(INSPPIRE： 儿童胰腺炎国际研究小组：寻求治疗)表型良好的CP儿童 减少疼痛，减少与疼痛相关的残疾，提高与健康相关的生活质量。的总体假设 这一应用是，基于网络的CBT将显著改善疼痛、疼痛相关残疾和 HRQOL。我们计划招募260名儿童和青少年(10-17岁)的多中心大样本 与来自INSPPIRE中心的CP及其父母一起评估WebMAP的疗效。研究设计是一种 2(组)×3(时间点)随机、对照、双盲试验。参赛者将随机 被分配在8-10周内接受患者教育(WebED)或CBT(WebMAP)的在线访问 治疗期。主要研究结果是在治疗前立即测量疼痛相关的残疾。 治疗后及6个月随访。次要结果包括儿童报告的疼痛，与健康相关 生活质量，抑郁和焦虑症状，以及药物使用。我们还将评估基因 预测治疗反应的多态、临床和行为表型因素。这个项目 通过评估有史以来第一个非CP儿童的疼痛管理，代表了CP儿童疼痛管理的重大进步 对这些患者的药理学疼痛干预，这可能指导未来在管理方面的发展 与CP相关的慢性疼痛。这项研究计划的长期目标是开发有效和 可以低成本提供灵活的治疗方法，以减少慢性腹痛和与疼痛相关的症状 脑性瘫痪儿童的残疾。