A multi-site feasibility clinical trial of Retraining and Control Therapy (ReACT), a mind and body treatment for pediatric functional seizures
再训练和控制疗法 (ReACT) 的多中心可行性临床试验,这是一种针对儿童功能性癫痫发作的身心治疗方法
基本信息
- 批准号:10648379
- 负责人:
- 金额:$ 57.45万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-08-01 至 2026-07-31
- 项目状态:未结题
- 来源:
- 关键词:18 year oldAddressAdherenceAdolescenceAdultAftercareAlabamaAnxietyAwarenessBehavioralBenchmarkingChildChildhoodClinicClinicalClinical TreatmentClinical TrialsCodeCognitiveCognitive TherapyConsciousDataDiagnosisDimensionsE-learningElectroencephalographyEnrollmentEpilepsyEvidence based treatmentFamilyFamily memberFrequenciesFrightFunctional ImagingFutureGoalsHabitsHearingIndividualInterventionMeasuresMedicineMoodsParentsParticipantPatientsPediatric HospitalsPersonsPlacebosPreparationProviderPublishingQuestionnairesRandomizedRandomized, Controlled TrialsRecommendationReportingResearchSchoolsSeizuresSelective Serotonin Reuptake InhibitorSiteSupportive careSymptomsTechniquesTexasTimeTrainingTreatment Side EffectsUnconscious StateUniversitiesVideotapeWorkadaptive interventionarmbehavioral clinical trialclinically significantcollegecommon symptomdiarieseffective therapyefficacy trialemerging adultexperiencefollow up assessmentfollow-upimaging studyimprovedmedical schoolsmeetingsmind/bodymindfulnessmulti-site trialnervous system disordernovelpreventrecruitresponsestandard carestandard of caretargeted treatmenttreatment planningweb platformweb-based intervention
项目摘要
Project Summary/Abstract
Functional seizures (FS) are a type of functional neurological disorder (FND) characterized by seizure-like
symptoms without EEG correlates. FS are severely debilitating to children and families, making this a
significant clinical and societal burden. Recent research has revealed sense of control as a potential target for
pediatric FS treatment. Our previously published study demonstrated children with FS have decreased sense
of control over their actions compared to matched controls. Only one randomized controlled trial (RCT) for
treatment of pediatric FS has been conducted to date, which evaluated Retraining and Control Therapy
(ReACT). ReACT, developed by the PI, is a novel, adaptive intervention that aims to increase sense of control
via mindfulness and principles of habit reversal, a well-established treatment for involuntary tics. Our recently
published pilot RCT demonstrated that ReACT resulted in significantly reduced FS frequency compared to
supportive therapy, with 82% of children remaining FS-free for ≥2 months after ReACT. Further, our
preliminary data suggest sense of control significantly improves after ReACT, and increased sense of control
after ReACT is significantly related to reduced FS frequency, indicating sense of control is an effective target
for improving FS. The purpose of this study is to conduct a multi-site pilot feasibility clinical trial of ReACT, a
mind and body treatment for pediatric FS. In the study, 54 11-18-year-olds diagnosed with FS will be
randomized to engage in ReACT or the CATCH-IT web-based intervention (validated for treating mood in
children) at three sites: the University of Alabama at Birmingham, the Yale School of Medicine/Yale New
Haven Children’s Hospital and Baylor College of Medicine/Texas Children’s Hospital. FS frequency will be
measured from 30 days before treatment to 2 months after treatment. Participants and a family member will
complete baseline and follow-up assessments 7 days before treatment and 7 days and 2 months after
treatment. Feasibility of recruitment and retention will be measured by meeting annual recruitment goals and
the percent of participants who complete the 2-month follow-up. Sessions will be videotaped, and 20% of
therapy sessions will be coded for treatment fidelity using published guides to assess intervention fidelity in
behavioral clinical trials. Participant adherence to ReACT will be assessed by the percent of recommended
treatment sessions completed, and participants and parents will report if the patient used the treatment plan for
each FS episode using a FS diary.
项目摘要/摘要
功能性癫痫是一种以癫痫样发作为特征的功能性神经功能障碍
没有脑电波的症状是相关的。FS严重削弱了儿童和家庭的能力,使这成为一种
严重的临床和社会负担。最近的研究表明,控制感是
儿科FS治疗。我们之前发表的研究表明,患有FS的儿童感觉能力下降
与匹配的对照组相比,他们对自己的行为有更强的控制力。只有一项随机对照试验(RCT)
到目前为止,已经对儿童FS进行了治疗,评估了再培训和控制治疗
(反应)。由PI开发的Reaction是一种旨在增加控制感的新型适应性干预
通过正念和习惯逆转的原则,这是一种公认的治疗非自愿抽搐的方法。我们最近
已发表的试验性RCT显示,与ACTION相比,REACT导致FS频率显著降低
支持性治疗,在反应后2个月,82%的儿童保持无FS的≥。此外,我们的
初步数据显示,反应后控制感显著改善,控制感增强
反应后与FS频率降低显著相关,表明控制感是有效的靶标
用于改善FS。这项研究的目的是进行一项多点试点可行性临床试验,一个
儿童FS的精神和身体治疗。在这项研究中,54名11-18岁的被诊断为FS的人将被
随机参加Reaction或Catch-IT基于网络的干预(验证用于治疗情绪
儿童)在三个地点:阿拉巴马大学伯明翰分校、耶鲁医学院/耶鲁大学纽约分校
黑文儿童医院和贝勒医学院/德克萨斯儿童医院。FS频率将为
治疗前30天至治疗后2个月。参与者和一名家庭成员将
在治疗前7天、治疗后7天和2个月后完成基线和随访评估
治疗。招聘和保留的可行性将通过实现年度招聘目标和
完成2个月随访的参与者的百分比。会议将被录像,20%的
将使用出版的指南对治疗过程进行编码,以评估介入治疗的保真度
行为临床试验。参与者对回应的忠诚度将根据推荐的百分比进行评估
治疗疗程结束,参与者和家长将报告患者是否使用治疗计划
使用FS日记记录每一集FS。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Aaron D Fobian其他文献
Aaron D Fobian的其他文献
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{{ truncateString('Aaron D Fobian', 18)}}的其他基金
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 - 财政年份:2021
- 资助金额:
$ 57.45万 - 项目类别:
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:
10449133 - 财政年份:2021
- 资助金额:
$ 57.45万 - 项目类别:
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:
10286107 - 财政年份:2021
- 资助金额:
$ 57.45万 - 项目类别:
A sleep and media intervention to improve adolescents weight and risk of type 2 diabetes
睡眠和媒体干预可改善青少年体重和 2 型糖尿病风险
- 批准号:
10219566 - 财政年份:2016
- 资助金额:
$ 57.45万 - 项目类别:
A sleep and media intervention to improve adolescents weight and risk of type 2 diabetes
睡眠和媒体干预可改善青少年体重和 2 型糖尿病风险
- 批准号:
10430425 - 财政年份:2016
- 资助金额:
$ 57.45万 - 项目类别:
A sleep and media intervention to improve adolescents weight and risk of type 2 diabetes
睡眠和媒体干预可改善青少年体重和 2 型糖尿病风险
- 批准号:
9179841 - 财政年份:2016
- 资助金额:
$ 57.45万 - 项目类别:
A sleep and media intervention to improve adolescents weight and risk of type 2 diabetes
睡眠和媒体干预可改善青少年体重和 2 型糖尿病风险
- 批准号:
9324259 - 财政年份:2016
- 资助金额:
$ 57.45万 - 项目类别:
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