Retraining and Control Therapy (ReACT): Sense of control and catastrophic symptom expectations as targets of a cognitive behavioral treatment for pediatric psychogenic non-epileptic seizures (PNES)

项目摘要/摘要 心理性非癫痫发作(PNES)是一种功能性神经功能障碍(FND) 以癫痫样症状为特征，没有脑电相关。PNES对儿童来说是严重虚弱的 家庭，使这成为一个重大的临床和社会负担。最近的研究揭示了灾难性的 症状期望值和控制感可作为儿科PNES治疗的潜在目标。患有以下疾病的儿童 PNES有更大的灾难性症状预期，或将身体感觉解释为 比他们的兄弟姐妹和患有癫痫的同龄人更具伤害性、紧张性和令人不安。灾难性症状 已经发现，这样的预期实际上会引发预期的症状。此外，孩子们也不会 对PNES症状有控制感，表明儿童认为PNES是非自愿的 无法控制。在成年人中，使用认知行为疗法或SSRIs来针对情绪和焦虑的研究 与对照条件相比，PNES没有显著降低。在不同的认知中 行为方法，本研究的目的是评估控制感和灾难性症状 期望作为再培训和控制疗法的治疗目标--一种新的认知行为 儿童PNES的治疗由PI开发。我们最近发布的RCT显示了一个重要的 反应后PNES频率的减少和控制感的增加与减少显著相关 PNES患儿的PNES频率。在R61阶段，9至18岁被诊断为PNES的青少年将 参与12个会议的反应。对行动的控制感将通过魔力和动荡来衡量 任务，灾难性的症状预期将通过皮质醇对冷加压任务7的反应来衡量 治疗前及治疗第8、12疗程后第7天(评估治疗剂量)。PNES 结果将通过治疗前和治疗后30天内PNES的数量来衡量。这项研究将 如果满足GO标准(科恩的d效果大小≥0.5)，则进入R33阶段 目标。对于R33，儿童将被随机分为反应或积极治疗(支持性治疗)， 治疗前7天、治疗后7天、治疗后6个月进行疗效评定。这个 将评估目标参与的复制与支持性治疗的比较，以及以下情况的程度 目标的变化与PNES频率的变化将被确定。预赛 将对PNES的反应有效信号进行评估，为更大规模的多中心RCT评估做准备 Reaction治疗儿童PNES的疗效观察

Project Summary/Abstract Psychogenic non-epileptic seizures (PNES) are a type of functional neurological disorder (FND) characterized by seizure-like symptoms without EEG correlates. PNES is severely debilitating to children and families, making this a significant clinical and societal burden. Recent research has revealed catastrophic symptom expectations and sense of control as potential targets for pediatric PNES treatment. Children with PNES have greater catastrophic symptom expectations, or the interpretation of physical sensations as injurious, intense and disturbing, than their siblings and peers with epilepsy. Catastrophic symptom expectations such as these have been found to actually induce the expected symptom. Also, children do not have a sense of control over PNES symptoms, indicating that children perceive PNES to be involuntary and uncontrollable. In adults, studies using cognitive behavioral therapy or SSRIs to target mood and anxiety have demonstrated no significant reduction in PNES compared to control conditions. In a different cognitive behavioral approach, the aim of this study is to assess sense of control and catastrophic symptom expectations as treatment targets of Retraining and Control Therapy (ReACT), a novel cognitive behavioral treatment for pediatric PNES developed by the PI. Our recently published RCT demonstrated a significant decrease in PNES frequency after ReACT, and increased sense of control was significantly related to reduced PNES frequency in children with PNES. In the R61 phase, nine to 18-year olds diagnosed with PNES will engage in 12 sessions of ReACT. Sense of control over actions will be measured by the magic and turbulence task, and catastrophic symptom expectations will be measured by cortisol response to the cold pressor task 7 days before treatment and 7 days after the 8th and 12th treatment sessions (to evaluate treatment dose). PNES outcomes will be measured by number of PNES in the 30 days before and after treatment. The study will proceed to the R33 phase if Go criteria are met (Cohen's d effect size ≥ 0.5) for engagement of one of the targets. For the R33, children will be randomized to either ReACT or an active therapy (supportive therapy), and outcomes will be measured 7 days before and after treatment and 6 months after treatment. The replication of target engagement will be assessed as compared to supportive therapy, and the extent to which the change in the targets is associated with change in PNES frequency will be determined. The preliminary signal of efficacy for ReACT on PNES will be evaluated to prepare for a larger multicenter RCT assessing the efficacy of ReACT on pediatric PNES.