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

青少年焦虑认知偏差修正的有效性试验

基本信息

批准号：
9238506
负责人：
GREGORY N CLARKE
金额：
$ 66.75万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-05-01 至 2019-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9238506
关键词：
Address Adherence Adolescence Adolescent Adult Adverse effects Age Antidepressive Agents Anxiety Anxiety Disorders Benchmarking Caring Categories Characteristics Childhood Clinical Clinical effectiveness Cognitive Cognitive Therapy Comorbidity Computerized Medical Record Computers Cost Effectiveness Analysis Diagnosis Diagnostic Direct Costs Disease Disease remission Enrollment Ethnic Origin Evidence based treatment Facilities and Administrative Costs Family Future Gender Healthcare Healthcare Systems Home environment Intervention Mediating Mediation Mediator of activation protein Mental Depression Mental Health Mental disorders Modification Motivation Outcome Parents Participant Patients Phonation Population Preparation Process Psychopathology Psychotherapy Public Health Quality-Adjusted Life Years Race Randomized Recurrence Risk Role Sampling Selective Serotonin Reuptake Inhibitor Self-Administered Services Severities Symptoms Teenagers Telephone Testing Time Training Variant Youth alternative treatment anxiety symptoms anxiety treatment anxious arm attentional bias attentional control base childhood anxiety clinical practice computerized cost cost effective cost effectiveness demographics depressive symptoms disability effectiveness trial follow up assessment functional disability health related quality of life improved indexing information processing novel premature primary outcome programs public health relevance scaffold secondary outcome symptomatology theories treatment as usual uptake

项目摘要

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.

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，与严重残疾以及复发和新发精神病理学的风险相关。尽管有强有力的证据证明 CBT 和抗抑郁药对焦虑症有效，但在临床实践中采用这些干预措施仍存在重大障碍，导致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针对青少年焦虑症的低成本、有效、可及且易于传播的服务的需求，该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疗法，几乎没有或根本没有与现有循证治疗相关的吸收障碍。我们将在 12 至 17 岁青少年中开展一项大型（N = 498）随机 CBM 疗效-效果试验，并在常规基础治疗 (TAU) 的背景下进行检查。在这项随机对照试验中，我们测试了向焦虑的青少年充分提供自我管理的 CBM 变体所需的支持水平（“脚手架”），为未来以部署为重点的试验做好准备。青少年被随机分配到： 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的家用计算机上的自我管理的主动 CBM（仅限自我管理的 CBM；第 2 组），或者自我管理的主动 CBM 与通过研究中的简短电话通话提供的依从性促进 (AP) 组件配对教练，包括简短的激励增强和/或技术援助（自我管理的 CBM+AP；第 3 组）。 CBM 课程每周举办 3 次，持续 4 周（总共 12 次）。随访评估在注册后 1、3、6 和 12 个月进行。与对照条件相比，我们假设两种活跃的 CBM 条件都会产生更大的焦虑诊断缓解，以及次要结果焦虑和抑郁症状和功能的更大改善。我们还假设，与仅 CBM（第 2 组）相比，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。我们还将进行成本效益分析，并假设积极 CBM 的每单位无焦虑天数和健康相关生活质量的增量成本将会更低 (Arm 2 + Arm 3) 相对于控制条件 (Arm 1)。我们将探索适度和保真度因素，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特征的变化具有稳健性。我们将测试与没有 AP 的条件（第 3 组与第 1 + 2 组）相比，CBM+AP 条件是否会导致更高的参与者参与度和合规性。最后，我们将研究注意力偏差变化在产生 CBM 效应中的中介作用。如果 CBM 被证明对焦虑有效，并且可以在家中、自我管理的方式轻松实施，那么它将允许更广泛地将新型焦虑 EBT 应用于急需的青少年。