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

描述（由申请人提供）：本申请描述了一种互锁的双位点协作R 01，以测试初级保健中出现焦虑和/或抑郁的青少年（8-15岁）的简短认知行为治疗（BCBT）方案的效果。在五年的时间里，210名青年（每个站点105名）将被随机分配到（a）初级保健中提供的BCBT或（B）加强转诊到专业精神卫生保健（SMHC）。该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广泛接受，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与增强的SMHC转诊模型，以确定其作为基于社区的干预措施的效用。在随机化后16周和32周（目标1），将由对受试者状态不知情的独立评价者评估结局。假设BCBT在总体临床改善（CGI-I < 2）和焦虑（PARS）和抑郁（CDRS-R）症状变化方面上级增强的SMHC转诊。还将根据简短的自我报告措施（SCARED、MFQ）对反应进行评估，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，将检查受试者的个体轨迹，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（青年和/或父母）将预测治疗反应较差，但BCBT计划仍将优于增强SHMC转诊模型。种族的影响也将被探讨，使用两个网站将允许更多的西班牙裔（圣地亚哥）和非洲裔美国人（匹兹堡）家庭的入组比可以实现任何一个孤立的。 将抑郁症和焦虑症作为一个统一的问题领域是创新的，符合对概念化共病和治疗近邻障碍的新方法的呼吁。需要一个有效的BCBT计划来内化青少年，因为服务机构在有限的会议和资源中挣扎，以培训临床医生多种协议。值得注意的是，该应用程序采用了以部署为中心的模型，并在真实的世界背景（初级保健）和与未来治疗传播相关的合理公共卫生比较条件（增强SMHC转诊）中对其开发早期进行了测试。初级保健实际上已成为提供精神保健的场所，有可能更容易获得、更早发现和治疗以及预防慢性病。根据这一重点，将收集关于方案成本效益的数据（目标3），以便为今后侧重于传播、执行和真实的世界可持续性问题的调查奠定基础。网站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）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：这项研究将测试基于初级保健的简短（12周）心理治疗计划是否可以帮助青少年与抑郁和焦虑作斗争。将衡量该方案对症状和成本效益的影响。这将是第一个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方法付诸社区实践。

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.