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

描述（由申请人提供）：焦虑症是青少年最常见的心理健康问题，与严重残疾以及复发和新发精神病理学风险相关。虽然存在CBT和抗抑郁药治疗焦虑症的有效性的强有力证据，但在临床实践中存在阻碍这些干预措施的重大障碍，导致任何青年诊断类别中这种疾病的治疗率最低（不到1/3的青年）。为了解决公共卫生需要低成本，有效的，可访问的，易于传播的青少年焦虑服务，本申请测试计算机认知偏差修正（CBM）作为一种新的，替代治疗与现有的循证治疗相关的吸收障碍很少或没有。我们将在12至17岁的青少年中进行一项大型（N = 498）CBM随机疗效-有效性试验，以常规基础治疗（TAU）为背景进行检查。在这个随机对照试验中，我们测试了支持（“脚手架”）的水平，需要充分提供一个自我管理的CBM的变体焦虑的青年，在未来的部署为重点的试验做准备。青少年被随机分为两组：一组是最低限度有效的注意力控制CBM程序（第一组）;另一组是下载并安装在参与者家用电脑上的自我管理的主动CBM程序（自我管理，仅建立信任措施;组2），或与通过研究教练的简短电话传递的依从性促进（AP）组分配对的自我施用的活性CBM，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举行3次，为期4周（共12次）。在入组后1、3、6和12个月进行随访评估。与对照组相比，我们假设两种积极的CBM条件将产生更大的焦虑诊断缓解，以及更大的改善次要结果焦虑和抑郁症状和功能。我们还假设，与仅CBM（组2）相比，CBM+AP（组3）将产生更大的焦虑诊断缓解和次要结局的更大改善。我们还将进行成本效益分析，并假设积极的CBM每单位无焦虑天数和健康相关生活质量的增量成本将较低 (Arm 2 +组3）相对于对照条件（组1）。我们将探讨适度和保真度的因素，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CBM+AP条件与无AP条件相比是否会导致更高的参与者参与度和依从性（第3组vs.第1组+第2组）。最后，我们将研究注意偏向变化在产生CBM效应中的中介作用。如果CBM被证明对焦虑有效，并且在这种家庭自我管理的形式中容易交付，它将允许将新型焦虑EBT更广泛地部署到有巨大需求的青少年中。

DESCRIPTION (provided by applicant): 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.