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

描述（由申请人提供）：焦虑症是青少年中最常见的心理健康问题，与严重的残疾和复发和新发精神病理的风险相关。尽管有强有力的证据表明CBT和抗抑郁药对焦虑的疗效，但在临床实践中，这些干预措施的采用存在重大障碍，这导致在任何青少年诊断类别中，这种疾病的治疗率最低（不到三分之一的青少年）。为了满足公共卫生对低成本、有效、可获得和易于传播的青少年焦虑症服务的需求，本应用程序测试了计算机化认知偏差修正（CBM）作为一种新颖的替代治疗方法，与现有的循证治疗方法相比，它几乎没有或根本没有接受障碍。我们将在12 - 17岁的青少年中进行一项大型（N = 498）随机疗效试验，在常规基础治疗（TAU）的背景下进行检查。在这项随机对照试验中，我们测试了向焦虑青年充分提供自我管理的CBM变体所需的支持水平（“脚手架”），为未来的部署重点试验做准备。青少年被随机分配到以下两组：CBM计划的最低有效注意力控制版本（第1组）；下载并安装在参与者家用电脑上的自我管理的主动CBM（仅自我管理的CBM； Arm 2），或自我管理的主动CBM与依从性促进（AP）组件配对，通过学习教练的简短电话提供，包括简短的动机增强和/或技术援助（自我管理的CBM+AP； Arm 3）。CBM每周进行3次，持续4周（总共12次）。随访评估在入组后1、3、6和12个月进行。与对照组相比，我们假设两种活跃的CBM条件都会产生更大的焦虑诊断缓解，以及次要结局焦虑和抑郁症状和功能的更大改善。我们还假设CBM+AP（第3组）与仅CBM（第2组）相比，会产生更大的焦虑诊断缓解和次要结局的改善。我们还将进行成本效益分析，并假设主动CBM的单位无焦虑天数和健康相关生活质量的增量成本将更低

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.