1/2-Brief CBT for Pediatric Anxiety and Depression in Primary Care

描述（由申请人提供）：本申请描述了一个联锁的，两个站点的协作R01，以测试一个简短的认知行为治疗（bbct）方案对在初级保健中表现为焦虑和/或抑郁的青少年（8-15岁）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)初级保健提供的BCBT或(b)加强专业精神卫生保健（SMHC）的转诊。该应用程序建立在一项初步研究（N=60）的基础上，在该研究中，bbct的试点版本被家庭和临床医生广泛接受，并且比转诊到SMHC更有效。我们现在建议在一个更大、更多样化的样本中测试bbct与增强的SMHC转诊模型，以确定其作为社区干预的效用。结果将由独立的评估人员在随机化后16周和32周对参与者状态进行盲测（目的1）。假设bbct在总体临床改善（CGI-I < 2）和焦虑（PARS）和抑郁（CDRS-R）症状的改变方面优于强化SMHC转诊。反应也将通过简短的自我报告测量（SCARED， MFQ）进行评估，因为未来的社区护理可能需要更多地依赖于这些类型的评估。此外，参与者的个人轨迹将被检查，以了解治疗反应的预测因素（目标2）。假设抑郁症状的严重程度（青年和/或父母）将预测治疗的不良反应，但bbct计划仍将优于增强的SHMC转诊模型。还将探讨种族的影响，使用两个网站将使西班牙裔（圣地亚哥）和非洲裔美国人（匹兹堡）家庭的入学率比单独使用任何一个网站都要高。将抑郁和焦虑作为一个统一的问题领域是创新的，符合对概念化合并症和治疗近邻疾病的新方法的呼吁。由于培训临床医生的时间和资源有限，因此需要一个有效的BCBT项目来内化年轻人。值得注意的是，采用了以部署为重点的模型，并在开发早期在现实世界背景下（初级保健）和与未来治疗传播相关的合理的公共卫生比较条件（加强SMHC转诊）中对这种干预措施进行了测试。初级保健实际上已成为提供精神卫生保健的场所，有可能更容易获得，更早发现和治疗，并预防慢性疾病。根据这一重点，将收集有关该方案成本效益的数据（目标3），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。站点独特的贡献包括基于实践的研究（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整体协调地点。

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.