Child/Adolescent Anxiety Multimodal Study (CAMS): rationale, design, and methods.
Child/Adolescent Anxiety Multimodal Study (CAMS): rationale, design, and methods.
复制标题
儿童/青少年焦虑多模式研究 (CAMS)：基本原理、设计和方法。
DOI：
10.1186/1753-2000-4-1
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发表时间：
2010-01-05
影响因子：
5.6
通讯作者：
March, John S
中科院分区：
文献类型：
--
作者：
Compton, Scott N;Walkup, John T;Albano, Anne Marie;Piacentini, John C;Birmaher, Boris;Sherrill, Joel T;Ginsburg, Golda S;Rynn, Moira A;McCracken, James T;Waslick, Bruce D;Iyengar, Satish;Kendall, Phillip C;March, John S
为了介绍儿童/青少年焦虑多模式研究（CAMS）的设计、方法和基本原理，这是一项最近完成的联邦政府资助的、多地点、随机安慰剂对照试验，该试验检验了认知行为疗法（CBT）、舍曲林（SRT）及其联合疗法（COMB）与药丸安慰剂（PBO）治疗儿童和青少年分离性焦虑障碍（SAD）、广广性焦虑障碍（GAD）和社交恐惧症（SoP）的相对疗效。简要回顾CAMS试验的急性结局，以及儿童焦虑症的心理社会和药物治疗文献，描述CAMS试验的设计和方法。CAMS是一项为期6年、6个试验点的随机对照试验。488名（N = 488）被DSM-IV-TR诊断为SAD、GAD或SoP的儿童和青少年（年龄7-17岁）被随机分配到四种治疗条件中的一种：CBT、SRT、COMB或PBO。焦虑症状、安全性和功能结果的评估，以及治疗反应的推定中介和调节因子的评估以多测量、多信息来源的方式完成。手工治疗，训练有素的临床医生和独立的评估人员使用，以确保治疗和评估的保真度。由所有试验点代表组成的多层管理结构促进了整个试验、研究方案和质量保证的跨试验点协调。CAMS通过使用最先进的方法和严格的跨站点质量控制，为适用于社会心理和精神药理学比较治疗试验的临床试验方法提供了一个模型。CAMS还对迄今为止最常见的儿童焦虑症的最佳循证心理治疗（CBT）和药物治疗（SSRI）的相对和综合疗效和安全性进行了大规模检查。CAMS的主要和次要结果将对告知与实践相关的决定有关青少年焦虑症的初始治疗具有重要意义。ClinicalTrials.gov NCT00052078。
To present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS), a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT), sertraline (SRT), and their combination (COMB) against pill placebo (PBO) for the treatment of separation anxiety disorder (SAD), generalized anxiety disorder (GAD) and social phobia (SoP) in children and adolescents. Following a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described. CAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488) children and adolescents (ages 7-17 years) with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance. CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT) and pharmacologic (SSRI) treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results of CAMS will hold important implications for informing practice-relevant decisions regarding the initial treatment of youth with anxiety disorders. ClinicalTrials.gov NCT00052078.