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: 10165706
• 负责人: Tonya M Palermo
• 金额: $ 62.43万
• 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 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10165706
• 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; Placebos; 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; 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.

项目总结