Predicting Treatment Response in Pediatric Functional Abdominal Pain

描述(由申请人提供)：我们在这项修订申请中的研究目标是确定儿科功能性腹痛(FAP)的个体差异，这些差异可以预测干预措施的不同健康结果，并可用于进一步为FAP量身定制干预措施。FAP是儿童中最常见的疼痛问题之一，它前瞻性地预测了成人早期慢性疼痛、残疾和频繁使用卫生服务(HSU)的风险。因此，提供有效的FAP治疗是一个重要的公共卫生问题。由训练有素的专业人员在面对面的会议中提供的认知行为疗法(CBT)已被发现可以减轻一些FAP患者的疼痛，但这样密集的资源并不普遍适用于大多数FAP患者。这项拟议的研究将评估治疗FAP的替代方法。这项研究整合并扩展了主要研究人员在儿科疼痛方面的最新工作。在一项针对青春期晚期/成年期早期的儿科首发FAP患者的前瞻性自然历史研究中，Pi Walker及其同事确定了三种不同的患者特征(即低疼痛适应、高疼痛适应、高疼痛功能障碍)，包括疼痛严重程度、疼痛认知和童年初始FAP评估时的影响。这些疼痛特征预测了近十年后随访(FU)时的慢性疼痛和残疾。在FU的实验室疼痛测试中，在基线水平具有高度疼痛功能障碍的患者的症状结果最差，并且也表现出有利于伤害的中枢性疼痛调制。FAP疼痛特征组的异质性表明，他们可能在治疗需求和从行为干预中受益的程度上有所不同。共同调查者Palermo为患有各种慢性疼痛的年轻人开发并测试了CBT干预(基于网络的青少年疼痛管理；Web-MAP)。这一有效、易于传播的治疗包括在线向青年和家长提供的单独模块。与通常的护理、等待名单控制条件相比，WebMAP在线CBT显著减少了青少年的疼痛和残疾。目前的提案将这些研究方向合并为 一项创新研究将首次：(目标1)实施专门针对FAP的在线CBT，并评估其疗效与在线信息、注意控制条件的比较；(目标2)评估治疗反应的基线调节因素，包括我们先前验证的FAP疼痛情况、有利于伤害的中枢性疼痛调制和父母特征(保护性、模型化疼痛行为、使儿童疼痛恶化)；以及(目的3)评估在线CBT对健康结果影响的潜在中介。在医学评估之后，年龄在11-17岁的FAP患者(n=300)及其父母将随机接受在线CBT或在线信息治疗。评估将在基线、治疗中期和治疗后以及基线后6个月和12个月进行。这项研究将产生可用于根据FAP患者的个人特征更有效地针对他们的干预措施的知识，从而将循证护理扩展到更多的患者，并最终降低总体护理成本。

DESCRIPTION (provided by applicant): The goal of our research in this revised application is to identify individual differences in pediatric functional abdominal pain (FAP) that predict differential health outcomes in response to an intervention and can be used to further tailor interventions for FAP. FAP is among the most common pain problems in childhood and prospectively predicts risk for chronic pain, disability, and frequent health service utilization (HSU) in early adulthood. Therefore, providing effective treatments of FAP is a critical public health concern. Cognitive behavior therapy (CBT) delivered by highly trained professionals in face-to-face sessions has been found to reduce pain in some FAP patients, but such intensive resources are not generally available to most FAP patients. The proposed study will evaluate an alternative approach to treating FAP. The study integrates and extends recent work by leading investigators in pediatric pain. In a prospective natural history study of pediatric onset FAP patients followed into late adolescence/early adulthood, PI Walker and colleagues identified three distinct patient profiles (i.e., Low Pain Adaptive, High Pain Adaptive, High Pain Dysfunctional) comprised of pain severity, pain cognitions, and affect at the time of the initial FAP evaluation in childhood. These pain profiles predicted chronic pain and disability at follow-up (FU) nearly a decade later. Patients with the High Pain Dysfunctional profile at baseline had the poorest symptom outcomes and also exhibited pro-nociceptive central pain modulation in laboratory pain tests at FU. The heterogeneity of the FAP pain profile groups suggests that they may differ in treatment needs and in the extent to which they benefit from behavioral interventions. Co- Investigator Palermo developed and tested a CBT intervention (Web-based Management of Adolescent Pain; Web-MAP) for youth with various chronic pain conditions. This efficient, easily disseminated treatment includes separate modules delivered online to youth and parents. WebMAP Online CBT significantly reduced youths' pain and disability in comparison to a usual care, wait-list control condition. The current proposal merges these lines of research into an innovative study that will, for the first time: (Aim 1) administer Online CBT adapted specifically for FAP and evaluate its efficacy compared to an Online Information, attention control condition; (Aim 2) evaluate baseline moderators of treatment response, including our previously validated FAP pain profiles, pro-nociceptive central pain modulation, and parent characteristics (protectiveness, modeling pain behavior, catastrophizing about the child's pain); and (Aim 3) evaluate potential mediators of the effect of Online CBT on health outcomes. Following medical evaluation, FAP patients (n = 300) ages 11-17 years and their parents will be randomized to Online CBT or Online Information. Assessments will be at baseline, mid- and post-treatment, and at 6- and 12-months post baseline. The study will produce knowledge that can be used to more efficiently target interventions to FAP patients according to their individual profiles and thereby extend evidence-based care to more patients and ultimately reduce overall costs of care.