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

项目摘要/摘要：焦虑症是青少年最常见的心理健康问题 并与严重的残疾和复发和新发精神病理学的风险有关。虽然 有强有力的证据证明CBT和抗抑郁药对焦虑的有效性，但也存在显著的障碍 妨碍在临床实践中采用这些干预措施，导致这一问题的治疗率最低 任何青年诊断类别的精神障碍(少于1/3的青年)。为了解决公共卫生问题 需要低成本、有效、易获得、易于传播的青少年焦虑服务，此应用程序 测试计算机化认知偏差修正(CBM)作为一种新的替代疗法，很少或根本没有 与现有循证治疗相关的吸收障碍。我们将进行一次大规模的(N= 498 ), 在12至17岁青年中进行的CBM随机疗效-有效性试验，背景为 基本治疗照常(TAU)。在这个RCT中，我们测试所需的支持级别(“脚手架”) 向焦虑的年轻人充分交付自我管理的CBM变体，为未来的部署做好准备- 集中试验。年轻人被随机分成两组：最低有效的注意力控制版本的CBM 计划(ARM 1)；自行管理的主动CBM，下载并安装在参与者家中 计算机(仅限自我管理的CBM；ARM 2)，或与配对的自我管理的活动CBM 遵从性促进(AP)部分通过研究教练的简短电话提供，包括简要 激励增强和/或技术援助(自行管理的CBM+AP；ARM 3)。煤层气会话 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。与控制条件相比，我们假设两种活跃的煤层气条件都将产生 更大的焦虑症诊断缓解， 和更大的改善次要结果焦虑和 抑郁症状和功能。我们还假设 CBM+AP(ARM 3)将产生更大的焦虑 与单纯使用CBM(ARM 2)相比，诊断缓解和次要结果有更大改善。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- 与对照组相比，活动的CBM(ARM 2+ARM 3)的自由天数和健康相关生活质量将更低 状态(臂1)。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对青少年临床和人口学特征的变化是否具有很强的抵抗力。我们将测试是否 与CBM+AP条件相比，CBM+AP条件可带来更高的参与者参与度和遵从性 没有AP(手臂3对手臂1+2)。最后，我们将考察注意偏向变化在 产生煤层气效应。如果CBM被证明对焦虑有效，并在这种在家、自我生活中轻松交付 管理形式，它将使一种新的焦虑EBT更广泛地部署到急需帮助的青年中。

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.