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

描述(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学的风险有关。尽管有强有力的证据表明CBT和抗抑郁药对焦虑的有效性，但在临床实践中，这些干预措施存在重大障碍，导致任何青年诊断类别的这种疾病的治疗率最低(不到三分之一的青年)。为了满足公众对低成本、有效、可获得和易于传播的青少年焦虑服务的需求，这项应用测试了计算机化认知偏差修正(CBM)作为一种新的替代治疗方法，几乎没有现有循证治疗方法所存在的吸收障碍。我们将在12至17岁的年轻人中进行一项大型的(N=498)CBM疗效-有效性随机试验，对照基础照常治疗(TAU)的背景进行检查。在这项随机对照试验中，我们测试了充分向焦虑的年轻人提供自我管理的CBM变体所需的支持水平(“脚手架”)，为未来以部署为重点的试验做准备。青少年被随机分为以下两组：最低有效的CBM计划(ARM 1)；自我管理的主动CBM，下载并安装在参与者的家庭计算机上(仅自我管理的CBM；ARM 2)，或者自我管理的主动CBM与通过研究教练的简短电话提供的遵从性促进(AP)组件配对，包括短暂的动机增强和/或技术援助(自我管理的CBM+AP；ARM 3)。CBM会议每周举行3次，为期4周(共12次)。后续评估在注册后1、3、6和12个月进行。与对照条件相比，我们假设，两种积极的CBM状态都将产生更大的焦虑诊断缓解，以及更大的次要结果焦虑和抑郁症状和功能的改善。我们还假设，与仅使用CBM(ARM 2)相比，CBM+AP(ARM 3)将产生更多的焦虑诊断缓解和次要结果的更大改善。我们还将进行成本效益分析，并假设积极活动的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 (臂2+臂3)相对于控制条件(臂1)。我们将探索适度和保真度因素，以指导未来的传播工作；例如，CBM是否对青少年临床和人口特征的变化具有很强的抵抗力。我们将测试与没有AP的条件相比，CBM+AP条件是否会导致更高的参与者参与度和遵从性(ARM 3与ARM 1+2)。最后，我们将考察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，并在这种在家、自我管理的形式下轻松交付，它将允许在迫切需要的青年中更广泛地部署一种新型的焦虑EBT。

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.