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%的儿童和青少年慢性胰腺炎（CP）患者存在腹痛。当疼痛变成 更频繁和更严重，它导致儿童健康的可衡量的下降，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 地理距离治疗中心。通过互联网提供治疗的替代形式可以 克服这些障碍。我们已经在开发和评估互联网方面取得了重大进展- 这是一项名为“基于网络的青少年疼痛管理”（WebMAP）的心理干预措施。我们 一项多中心随机对照试验的结果表明， 干预经历了显着改善疼痛相关的残疾，抑郁症，和父母认为， 与仅接受患者教育的儿童相比，疼痛的影响。拟议的项目旨在 运用我们的专业知识，为最大的群体提供基于互联网的疼痛管理计划（INSPPIRE： 国际小儿胰腺炎研究小组：寻找良好表型的CP患儿的治疗方法 减少疼痛、疼痛相关残疾，并提高健康相关生活质量。总体假设 这种应用是基于网络的CBT将显着改善疼痛，疼痛相关的残疾， HRQOL。我们计划招募260名儿童和青少年（年龄10-17岁）的大型多中心样本 与来自INSPPIRE中心的CP及其父母一起评估WebMAP的有效性。研究设计是 两个（组）×三个（时间点）随机对照双盲试验。参与者将随机 被分配在8-10周内接受在线患者教育（WebED）或CBT（WebMAP） 治疗期。主要研究结果是在治疗前立即测量疼痛相关残疾 治疗后和6个月随访时。次要结局包括儿童报告的疼痛、健康相关 生活质量、抑郁和焦虑症状以及药物使用。我们还将评估遗传 多态性、临床和行为表型因素预测治疗反应。这个项目 通过评估第一个非- 这些患者的药物疼痛干预，这可能会指导未来的发展， 与CP相关的慢性疼痛。该研究计划的长期目标是开发有效且 灵活的治疗，可以以低成本提供，以减少慢性腹痛和疼痛相关的 CP儿童的残疾。