Combining one-session treatment with a homework program including app-based technology to enhance the treatment of childhood specific phobias: A study protocol of a multicenter pragmatic randomized controlled trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
A.M. Klein , A. Hagen , J. Rahemenia , E. de Gier , R.M. Rapee , M. Nauta , E. de Bruin , J. Biesters , L. van Rijswijk , A. Bexkens , J.M.D. Baartmans , L. Mobach , R. Zimmermann , K. Krause , S.M. Bögels , T.H. Ollendick , S. Schneider
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引用次数: 0

Abstract

Introduction

Childhood specific phobias are among the most common and earliest onset mental disorders with a lifetime prevalence of more than ten percent. Brief intensive cognitive behavioral therapy (CBT) programs such as the One-Session Treatment (OST) are found to be effective in the remission of the specific phobias following treatment, but there is still room for improvement. The goal of the current study is to examine whether the long-term efficacy of OST increases by using a homework program supported by an app specifically designed for children; the Kids Beat Anxiety (KibA) homework program.

Methods

Children aged between 7 and 14 years with a specific phobia receive OST preceded by a three-week baseline phase to control for time-effects. Directly following OST, children are randomized to either a four-week homework period supported by an app (OST + app), or standard One-Session Treatment with a four-week homework period that is only supported by therapist instructions (OST-only). Primary outcome variables are diagnosis and severity of the specific phobia. Secondary outcomes include behavioral avoidance, self-reported fear, and functional impairment. Data will be analyzed based on intention-to-treat and per protocol samples using mixed-effects multilevel linear models.

Ethics and dissemination

The current study was approved by the METC of the Academic Medical Center, Amsterdam, The Netherlands (number: NL72697.018.20) and the Ethical Committee of the Ruhr University, Bochum, Germany (number: 663). Results of this trial will be published in peer-reviewed journals.

Trial registration

The study was pre-registered at the Dutch Trial Register, number: NL 9216.

将一次疗程治疗与包括应用程序技术在内的家庭作业计划相结合,加强对儿童特定恐惧症的治疗:多中心实用随机对照试验的研究方案
导言:儿童特异性恐惧症是最常见、发病最早的精神障碍之一,终生患病率超过百分之十。简短强化认知行为疗法(CBT)项目,如 "一疗程疗法"(OST),在治疗后可有效缓解特异性恐惧症,但仍有改进的余地。本研究的目的是通过使用一个由专门为儿童设计的应用程序(儿童战胜焦虑(KibA)家庭作业程序)支持的家庭作业程序,来检验 OST 的长期疗效是否会提高。方法7 至 14 岁患有特定恐惧症的儿童在接受 OST 治疗之前,先接受为期三周的基线阶段治疗,以控制时间效应。OST 结束后,孩子们会被随机分配到一个为期四周、由应用程序支持的家庭作业阶段(OST + 应用程序),或一个为期四周、仅由治疗师指导的家庭作业阶段(仅 OST)。主要结果变量是特定恐惧症的诊断和严重程度。次要结果包括行为回避、自我报告的恐惧和功能障碍。本研究已获得荷兰阿姆斯特丹学术医学中心 METC(编号:NL72697.018.20)和德国波鸿鲁尔大学伦理委员会(编号:663)的批准。该试验的结果将在同行评审期刊上发表。试验登记该研究已在荷兰试验登记处进行了预先登记,登记号为 NL 9216:NL 9216。
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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