Developing a Low-Intensity Primary Care Intervention for Anxiety Disorders

描述（由申请人提供）：焦虑症是美国人口中最常见的一类心理健康问题，在初级保健中非常普遍。虽然他们与巨大的社会，教育和职业障碍，并增加医疗保健费用，很少有人得到适当的治疗。非常需要低强度、可扩展的非药物干预措施。虽然并非所有患者都可以在这些第一步治疗后获得缓解，但它们是实现最大程度减少整个人群痛苦的必要条件。认知偏差修正（CBM）使用简单的计算机任务直接针对焦虑症的认知脆弱性，是第一步可扩展干预的理想候选者。建立信任措施是计算机化的，需要最少的培训或提供者的时间。理想情况下，CBM的提供将与初级保健联系起来，因为这是大多数焦虑患者首次接受护理的环境。此外，与初级保健有关的 交付将允许初级保健提供者（PCP）监测患者的结果，并根据需要提供更密集的治疗。因此，本研究的总体目标是制定和完善CBM，以便在初级保健环境中提供可行和可接受的服务。第一、 我们将通过开发第一个跨诊断和个性化的CBM，为初级保健定制CBM。这一被称为“注意力和解释修正（AIM）"的CBM将包括一个计算机化的评估，以开发一套个性化的刺激和治疗，纠正注意力和解释偏差。AIM将通过8个30分钟的计算机会话进行。为了进一步促进未来的实施，我们将制定与初级保健相关的AIM提供方法，包括在家中完成会话的选项，同时仍由PCP进行监测。我们的开发工作将通过咨询小组（AP）对PCP，实践领导者，护士和患者的持续评估，以及我们团队通过使用准专业患者导航器创建快速，易于解释的PCP反馈系统的经验来了解。我们将进行一项AIM的开放试验（n = 18），以获得可行性和可接受性数据和经验，帮助我们完善AIM和交付方法。接下来，我们将进行一项先导性双盲随机对照试验（RCT; n=42）。试点随机对照试验将使我们能够检查AIM的可行性和可接受性，以及我们最终全面随机对照试验的研究程序。此外，这两项试验将使我们能够试验潜在的调节因素，包括基线注意力和解释偏差以及特定的焦虑症诊断。在未来的大规模随机对照试验中，焦虑症状严重程度将是主要结局，心理社会功能将是次要结局。这些目标的实现将使我们准备申请未来的R 01，以进行大规模的，充分的动力，混合有效性实施RCT测试AIM，一个初级保健相关的，个性化的CBM。这项工作将导致纳入初级保健的容易扩展，翻译，有效，非药物的精神健康治疗焦虑症患者。

DESCRIPTION (provided by applicant): Anxiety disorders are the most common class of mental health problem in the U.S. population and are highly prevalent in primary care. Although they are associated with great social, educational, and occupational impairment, and with increased health care costs, few people receive adequate treatment. There is a great need for low-intensity, scalable, non-pharmacological interventions. While not all patients may achieve remission after these first-step treatments, they are necessary to achieve the greatest reduction in suffering across the population at large. Cognitive Bias Modification (CBM), which uses simple computer tasks to directly target cognitive vulnerability to anxiety disorders, is an ideal candidate for a first-step, scalable intervention. CBM is computerized and requires minimal training or provider time. Ideally, CBM delivery would be linked to primary care, as this is the setting where the majority of anxious patients first present for care. Further, primary care-linked delivery will allow for primary care provider (PCP) monitoring of patient outcomes and provision of more intensive treatments as needed. The overarching goal of this study is thus to develop and refine CBM so that it is feasible and acceptable to deliver in the primary care setting. First, we will tailor CBM for primary care by developing the first transdiagnostic and personalized CBM. Entitled "Attention and Interpretation Modification (AIM)", this CBM will comprise both a computerized assessment to develop a personalized set of stimuli and a treatment, which corrects attention and interpretation biases. AIM will be delivered via 8, 30-minute computer sessions. To further facilitate future implementation, we will develop methods for primary care linked delivery of AIM, including an option to complete sessions at home while still being monitored by the PCP. Our development work will be informed by ongoing evaluation with an Advisory Panel (AP) of PCPs, practice leaders, nurses, and patients, and by our team's experience creating quick, easily interpretable PCP feedback systems via use of paraprofessional Patient Navigators. We will conduct an open trial of AIM (n = 18) to attain feasibility and acceptability data and experience to help us refine AIM and delivery methods. Next, we will conduct a pilot, double-blind randomized controlled trial (RCT; n=42). The pilot RCT will allow us to examine the feasibility and acceptability of AIM and of our research procedures for an eventual full-scale RCT. Further, both trials will allow us to pilot potential moderators including baseline attentional and interpretational bias and specific anxiety disorder diagnosis. In the future large-scale RCT, anxiety symptom severity will be the primary outcome and psychosocial functioning will be the secondary outcome. Achievement of these aims will prepare us to apply for a future R01 to conduct a large-scale, adequately powered, hybrid effectiveness-implementation RCT testing AIM, a primary care-linked, personalized CBM. This line of work will lead to the incorporation into primary care of readily scalable, translational, effective, non-pharmacological mental health treatment for patients with anxiety disorders.