2/2-Brief CBT for Pediatric Anxiety and Depression in Primary Care

描述(由申请人提供)：本申请描述了一种连锁的两站点协作R01，以测试针对在初级保健中表现出焦虑和/或抑郁的年轻人(8-15岁)的简短认知行为治疗(BCBT)协议的效果。在五年的时间里，210名青少年(每个地点105名)将被随机分配到(A)在初级保健中提供的BCBT或(B)加强转介到专科精神卫生保健(SMHC)。这项应用建立在初步研究(N=60)的基础上，在该研究中，BCBT的试点版本被家庭和临床医生很好地接受，并且比转诊到SMHC更有效。我们现在建议在更大、更多样化的样本中测试BCBT和增强的SMHC转诊模型，以确定其作为基于社区的干预的实用性。结果将由独立评估者在随机化后16周和32周(目标1)不考虑参与者状况的情况下进行评估。据推测，BCBT在总体临床改善(CGI-I&lt；2)以及焦虑(PARS)和抑郁(CDRS-R)症状的改变方面将优于增强型SMHC转诊。应对措施也将根据简短的自我报告措施(SCARED，MFQ)进行评估，因为未来的社区护理可能需要更多地依赖这些类型的评估。此外，还将检查参与者的个人轨迹，以了解治疗反应的预测因素(目标2)。据推测，抑郁症状的严重程度(青少年和/或父母)将预测治疗后较差的反应，但BCBT计划仍将优于增强型SHMC转诊模型。还将探索种族的影响，使用两个地点将允许更多的西班牙裔(圣地亚哥)和非裔美国人(匹兹堡)家庭的入学人数，而不是单独使用这两个家庭中的任何一个。将抑郁和焦虑作为一个统一的问题领域是创新的，符合对共病概念化和治疗近邻障碍的新方法的呼吁。随着服务设置与有限的会话和可用于培训临床医生的多种方案的资源作斗争，需要有一个有效的BCBT计划来使年轻人内化。值得注意的是，该应用采用了以部署为重点的模式，并在真实世界背景下(初级保健)和与未来治疗传播相关的看似合理的公共卫生比较条件(增强型SMHC转诊)的早期开发中测试了这一干预措施。初级保健已成为事实上的精神卫生保健提供场所，有可能更容易获得，更早地识别和治疗，并预防慢性病。根据这一重点，将收集关于该方案(目标3)成本效益的数据，以便为今后侧重于传播、实施和现实世界可持续性问题的调查奠定基础。网站的独特贡献包括实践研究(圣地亚哥)和数据协调(匹兹堡)方面的专业知识。圣地亚哥将作为该项目的总体协调地点。 公共卫生相关性：这项研究将测试以初级保健为基础的简短(12周)心理治疗计划是否可以帮助与抑郁和焦虑作斗争的年轻人。将衡量该计划对症状和成本效益的影响。这将是第一项评估焦虑和抑郁是否可以用一个简单的程序来治疗的研究，结果可能有助于将这些严重问题的有效治疗转移到社区实践中。

DESCRIPTION (provided by applicant): This application describes an interlocking, two-site collaborative R01 to test the effects of a brief cognitive behavioral therapy (BCBT) protocol for youths (age 8-15) presenting with anxiety and/or depression in primary care. Over a five year period, 210 youths (105 per site) will be randomly assigned to (a) BCBT delivered in primary care or (b) enhanced referral to specialty mental health care (SMHC). This application builds on a preliminary study (N=60), in which a pilot version of BCBT was well-accepted by families and clinicians and was more efficacious than referral to SMHC. We now propose to test BCBT against an enhanced SMHC referral model in a larger, more diverse sample to establish its utility as a community-based intervention. Outcomes will be assessed by independent evaluators blind to participant status at 16 and 32 weeks post- randomization (Aim 1). It is hypothesized that BCBT will be superior to enhanced SMHC referral in terms of overall clinical improvement (CGI-I < 2) and change in anxiety (PARS) and depression (CDRS-R) symptoms. Response also will be evaluated on brief self-report measures (SCARED, MFQ), as future community care may need to rely more heavily on these types of assessments. In addition, individual trajectories of participants will be examined to understand predictors of treatment response (Aim 2). It is hypothesized that severity of depression symptoms (youth and/or parent) will predict poorer response across treatments but that the BCBT program will still outperform the enhanced SHMC referral model. The effects of ethnicity also will be explored and use of two sites will allow greater enrollment of Hispanic (San Diego) and African-American (Pittsburgh) families than could be achieved by either in isolation. Targeting depression and anxiety as a unified problem area is innovative and in line with calls for new approaches to conceptualizing comorbidity and treating near neighbor disorders. Availability of an effective BCBT program for internalizing youths is needed as service settings struggle with limited sessions and resources available to train clinicians in multiple protocols. The application is noteworthy in adopting a deployment-focused model and testing this intervention early in its development within a real world context (primary care) and against a plausible public health comparision condition (enhanced SMHC referral) relevant for future treatment dissemination. Primary care has become a de facto site of mental health care delivery, with the possibilities of easier access, earlier identification and treatment, and prevention of chronicity. In line with this focus, data will be collected on the cost-effectiveness of the program (Aim 3) in order to lay the groundwork for future investigations focused on issues of dissemination, implementation, and real world sustainability. Site-unique contributions include expertise in practice-based research (San Diego) and data coordination (Pittsburgh). San Diego will serve as the overall coordinating site for the project. PUBLIC HEALTH RELEVANCE: This study will test whether a brief (12 week) psychological treatment program, based in primary care, can help youths struggling with depression and anxiety. Impact of the program on symptoms and cost-effectiveness will be measured. This will be the first study to assess if anxiety and depression can be treated with one, simple program, and results may help move effective treatments for these serious problems into community practice.