Developing a Low-Intensity Primary Care Intervention for Anxiety Disorders

描述(申请人提供)：焦虑症是美国人群中最常见的一类心理健康问题，在初级保健中非常普遍。尽管它们与巨大的社会、教育和职业损害以及增加的医疗费用有关，但很少有人得到适当的治疗。非常需要低强度、可扩展的非药理学干预措施。虽然不是所有的患者在这些第一步治疗后都可能得到缓解，但它们对于最大限度地减少整个人群的痛苦是必要的。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易感性，是第一步可扩展干预的理想候选者。CBM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的交付将与初级保健联系在一起，因为这是大多数焦虑的患者首先接受护理的环境。此外，与初级保健相关的 提供服务将使初级保健提供者(PCP)能够监测患者的结局，并在需要时提供更多强化治疗。因此，这项研究的总体目标是开发和完善CBM，使其在初级保健环境中提供是可行的和可接受的。第一, 我们将通过开发第一个跨诊断和个性化的CBM，为初级保健量身定做CBM。这项题为“注意和解释修正(AIM)”的CBM将包括一项计算机化的评估，以开发一套个性化的刺激，并包括一项治疗，以纠正注意和解释偏差。AIM将通过8-30分钟的计算机课程进行讲解。为了进一步促进未来的实施，我们将制定与初级保健挂钩的AIM交付方法，包括在仍由初级保健中心监测的情况下在家中完成疗程的选择。我们的开发工作将通过与PCP、实践负责人、护士和患者组成的咨询小组(AP)进行的持续评估，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AIM(n=18)的公开试验，以获得可行性和可接受性数据和经验，以帮助我们改进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)。试验性随机对照试验将使我们能够审查AIM的可行性和可接受性，以及我们最终全面开展随机对照试验的研究程序。此外，这两个试验都将使我们能够试验潜在的调节因素，包括基线注意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，焦虑症状的严重程度将是主要结果，心理社会功能将是次要结果。这些目标的实现将使我们为申请未来的R01做好准备，以进行大规模、充足动力、混合有效性实施RCT测试AIM，一种与初级保健挂钩的个性化CBM。这项工作将导致将易于扩展的、可转换的、有效的、非药理学的精神健康治疗纳入初级保健，用于焦虑症患者。

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.