An Efficacy-Effectiveness Trial of Cognitive Bias Modification for Youth Anxiety

项目总结/摘要：焦虑症是青少年最常见的心理健康问题 并且与显著的残疾和复发和新发精神病理学的风险相关。虽然 有强有力的证据表明CBT和抗抑郁药对焦虑症的疗效， 阻碍在临床实践中采用这些干预措施，导致治疗率最低 任何青年诊断类别的疾病（少于1/3的青年）。为了解决公众健康问题 需要低成本，有效的，可访问的，易于传播的服务，青年焦虑，这种应用程序 测试计算机化的认知偏差修正（CBM）作为一种新的替代治疗方法， 与现有循证治疗相关的吸收障碍。我们将进行一个大型（N = 498 ), 在12至17岁的青少年中进行的CBM随机疗效-效果试验，在以下背景下进行检查： 常规基础治疗（TAU）。在这个随机对照试验中，我们测试了支持（“脚手架”）的水平， 向焦虑的青年充分提供自我管理的CBM变体，为未来的部署做准备- 集中审判。年轻人被随机分为两组：一组是最低限度有效的注意力控制版CBM 计划（第1组）;自行管理的主动CBM，下载并安装在参与者的家中 计算机（仅自我给药CBM;第2组），或自我给药主动CBM与 通过研究教练的简短电话提供依从性促进（AP）组件，包括简短的 动机增强和/或技术援助（自我管理CBM+AP;第3组）。建立信任措施会议 每周发生3次，持续4周（共12次）。随访评估在术后1、3、6和12个月进行。 招生与对照条件相比，我们假设两种主动煤层气条件都将产生 更大的焦虑诊断缓解， 次要结果焦虑和 抑郁症状和功能。我们还假设， CBM+AP（第3组）将产生更大的焦虑 诊断缓解和次要结局的更大改善，与仅CBM（组2）相比。我们 还将进行成本效益分析，并假设每单位焦虑的增量成本- 活性CBM（第2组+第3组）的自由活动天数和健康相关生活质量低于对照组 条件（第1组）。我们将探讨适度和保真度因素，为未来的传播工作提供信息;例如， CBM是否对青年临床和人口统计学特征的变化具有鲁棒性。我们将测试 与条件相比，CBM+AP条件导致更高的参与者参与度和合规性 无AP（第3组与第1 + 2组）。最后，我们将研究注意偏向变化的中介作用， 产生煤层气效应。如果CBM证明有效的焦虑和容易交付在这个在家里，自我- 管理的格式，它将允许更广泛地部署一种新的焦虑EBT的青年在很大程度上需要。

PROJECT SUMMARY/ABSTRACT: Anxiety disorders are the most common mental health problem in youth and are associated with significant disability and risk of recurrent and new onset psychopathology. Although strong evidence exists for the efficacy of CBT and antidepressants for anxiety, there are significant barriers impeding uptake of these interventions in clinical practice, contributing to lowest rate of treatment for this disorder for any youth diagnostic category (fewer than 1 in 3 youth). In order to address the public health need for low-cost, effective, accessible, and easy-to-disseminate services for youth anxiety, this application tests computerized Cognitive Bias Modification (CBM) as a novel, alternative treatment with few or none of the barriers to uptake associated with extant evidence-based treatments. We will conduct a large (N = 498 ), randomized efficacy-effectiveness trial of CBM in youth ages 12 to 17, examined against the background of underlying treatment as usual (TAU). In this RCT, we test the level of support ("scaffolding") needed to adequately deliver a self-administered variant of CBM to anxious youth, in preparation for future deployment- focused trials. Youth are randomized to either: a minimally effective attention-control version of the CBM program (Arm 1); self-administered active CBM that is downloaded and installed on participants' home computers (Self-Administered CBM-only; Arm 2), or to self-administered active CBM paired with an adherence promotion (AP) component delivered via brief telephone calls from study coaches, including brief motivational enhancement and/or technical assistance (Self-Administered CBM+AP; Arm 3). CBM sessions occur 3 times weekly over 4 weeks (12 total). Follow-up assessments occur at 1, 3, 6 and 12 months post- enrollment. Compared to the control condition, we hypothesize that both active CBM conditions will yield greater anxiety diagnosis remission, and greater improvement for secondary outcomes anxiety and depressive symptoms and functioning. We also hypothesize that CBM+AP (Arm 3) will yield greater anxiety diagnosis remission and greater improvement in secondary outcomes, compared to CBM-only (Arm 2). We also will conduct cost effectiveness analyses and hypothesize that the incremental cost per unit of anxiety- free days and health-related quality of life will be lower for active CBM (Arm 2 + Arm 3) relative to the control condition (Arm 1). We will explore moderation and fidelity factors to inform future dissemination efforts; e.g,, whether CBM is robust to variation in youth clinical and demographic characteristics. We will test whether the CBM+AP condition results in higher participant engagement and compliance compared to the conditions without AP (Arm 3 vs. Arms 1 + 2). Finally, we will examine the mediating role of attention-bias change in producing CBM effects. Should CBM prove efficacious for anxiety and easily deliverable in this at-home, self- administered format, it will permit the broader deployment of a novel anxiety EBT to youth in great need.