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)

再训练和控制疗法（ReACT）：将控制感和灾难性症状预期作为儿童心因性非癫痫发作（PNES）认知行为治疗的目标

• 批准号: 10718263
• 负责人: Aaron D Fobian
• 金额: $ 69.02万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-22 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10718263
• 关键词: 18 year old; Absenteeism at work; Address; Adolescence; Adult; Aftercare; Analgesics; Anxiety; Behavioral; Benchmarking; Biological Markers; Caring; Child; Childhood; Clinic; Clinical; Cognitive; Cognitive Therapy; Data; Diagnosis; Dimensions; Disease remission; Dose; Electroencephalography; Epilepsy; Esthesia; Family; Frequencies; Goals; Habits; Hand; Health; Hydrocortisone; Image; Magic; Manuals; Measures; Mediating; Medical; Modeling; Moods; Nitrous Oxide; Outcome; Pain; Parents; Participant; Patients; Persons; Phase; Placebos; Provider; Psychopathology; Publishing; Questionnaires; Randomized; Randomized, Controlled Trials; Research; Schools; Seizures; Selective Serotonin Reuptake Inhibitor; Severities; Siblings; Signal Transduction; Stress; Suggestion; Supportive care; Symptoms; Testing; Training; Trauma; Water; bodily sensation; comparison control; efficacy evaluation; emerging adult; expectation; improved; nervous system disorder; novel; peer; primary outcome; response; treatment comparison; verbal

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.

项目总结/摘要 心因性非癫痫性发作（PNES）是一种功能性神经障碍（FND） 其特征在于没有EEG相关性的癫痫样症状。PNES严重削弱儿童， 家庭，使这成为一个重大的临床和社会负担。最近的研究表明， 症状预期和控制感作为儿童PNES治疗的潜在目标。儿童 PNES具有更大的灾难性症状预期，或将身体感觉解释为 伤害性的，强烈的和令人不安的，比他们的兄弟姐妹和同龄人与癫痫。灾难性症状 已经发现诸如此类的期望实际上会引起预期的症状。此外，儿童不 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来治疗情绪和焦虑的研究 结果表明，与对照条件相比，PNES没有显著降低。在一个不同的认知 本研究的目的是评估控制感和灾难性症状， 期望作为再训练和控制疗法（ReACT）的治疗目标，这是一种新的认知行为疗法。 PI开发的儿科PNES治疗。我们最近发表的RCT显示， ReACT后PNES频率降低，控制感增加与减少 PNES儿童的PNES频率。在R61阶段，9至18岁被诊断患有PNES的奥尔兹将 参加12次ReACT会议。控制感将由行动的魔力和动荡来衡量 任务，灾难性症状的预期将通过皮质醇对冷加压任务7的反应来测量 治疗前10天以及第8次和第12次治疗后7天（评价治疗剂量）。PNES 结果将通过治疗前和治疗后30天内的PNES数量来衡量。这项研究将 如果符合Go标准（Cohen d效应量≥ 0.5），则进入R33阶段， 目标的对于R33，儿童将随机接受ReACT或积极治疗（支持治疗）， 治疗前后7天和治疗后6个月测量结果。的 与支持性治疗相比，将评估靶点接合的复制，以及 将确定目标的变化与PNES频率的变化相关联。初步 将评价ReACT对PNES的有效性信号，以准备更大规模的多中心RCT， ReACT对儿童PNES的疗效。