HeartRater:Clinical. Optimizing ADIE therapy for the treatment of anxiety in underserved populations. Follow up to Outline proposal (ref MR/X005755/1)

焦虑每年给英国造成89亿英镑的损失。它是最常见的精神疾病之一，也是许多精神疾病中重要的、常见的症状：在英国，焦虑占全科医生咨询的五分之一。针对焦虑症的靶向治疗是有限的，然而每年有170万人接受改善心理治疗（IAPT）服务，其中32%的人没有接受治疗。这些人包括自闭症患者和那些有复杂身体状况的人，比如关节活动过度。我们的患者和公众参与（PPI）小组发现，难以参与标准的谈话治疗是人们拒绝接受IAPT治疗的一个关键原因。我们针对焦虑的新疗法，内感受体验的对齐维度（ADIE），针对焦虑的身体方面，基于我们对内感受（身体变化的信号和感知）在情绪及其障碍中的贡献的十多年的科学和临床研究。我们的目标是优化ADIE，使其最终能够在NHS中实施，特别是对于那些目前可用选项服务不足的人。内感受描述的是对身体正在发生的事情的内在感觉。我们之前的工作已经显示了与焦虑相关的内感受的差异，特别是在自闭症个体和那些有复杂身体健康问题的个体中。ADIE是一种为期6期的内感受性训练方案。这项训练结合了心脏生理学（心跳）的实时测量和一套量身定制的计算机化训练任务。一项随机临床试验（RCT； N=121）证明了ADIE在改善自闭症成人焦虑方面的有效性。这项研究是由训练有素的研究人员亲自进行的，他们使用连接在笔记本电脑上的光学心脏传感器。最近的一项可行性随机对照试验（N=40）通过新的数字平台HeartRater:Clinical（使用平板电脑+心跳传感器+软件）在在线治疗师的指导下，成功地为家中身体状况复杂的患者提供了ADIE。该项目旨在提高ADIE作为成人焦虑治疗的可及性、包容性和参与度，特别是那些不能从标准治疗中受益的人，如自闭症成年人和有身体健康问题的人。与PPI合作，该项目将共同生产一个优化版本的HeartRater:Clinical，为IAPT服务患者提供ADIE作为独立的软件指导治疗：首先，ECG将取代光学心跳传感器，以提高外周循环不良和/或皮肤较黑的患者的信号可靠性。其次，用户界面将优化为软件指导管理，游戏化，以提高参与。接下来，一项2a期临床试验将测试HeartRater: clinical /ADIE作为一种“低强度”自我管理、软件指导的独立治疗的概念可行性，相对于“高强度”治疗师指导的使用，具有可行性、临床、定性和评估过程结果。最后，我们将为在NHS中实施HeartRater:Clinical铺平道路。我们将确保知识产权，并在专家合作伙伴的支持下，制定商业计划，绘制商业化路径，包括进一步资助研究（例如卫生技术评估（HTA） NHS随机对照试验），并进行卫生经济评估。

Anxiety costs the UK over £8.9 billion/yr. It is one of the most common mental illnesses and an important, frequent symptom across many psychiatric conditions: in the UK, anxiety contributes to 1 in 5 GP consultations. Access to targeted therapy for anxiety is limited, yet 32% of the 1.7M/year individuals referred to Improving Access to Psychological Therapies (IAPT) services do not take up therapy. These individuals include autistic people and those with complex physical conditions such as joint hypermobility. Our Patient and Public Involvement (PPI) panels identified difficulty engaging in standard talking therapies to be a key a reason for people declining offers of IAPT therapy. Our novel therapy for anxiety, Aligning Dimensions of Interoceptive Experience (ADIE), targets bodily aspects of anxiety and is based on over a decade of our scientific and clinical research on the contribution of interoception (signalling and perception of bodily changes) in emotion and its disorders. Our aim is to optimize ADIE so that it can ultimately be implemented in NHS, particularly for those underserved by the current available options. Interoception describes the internal sense of what is happening in the body. Our previous work has shown differences in interoception related to anxiety, particularly in autistic individuals and those with complex physical health problems. ADIE is an interoceptive training protocol delivered over 6 sessions. The training combines real time measurement of cardiac physiology (heartbeats) with a set of tailored computerised training tasks. A randomised clinical trial (RCT; N=121) demonstrated ADIE's effectiveness in improving anxiety in autistic adults. This study was run in-person by trained researchers using an optical cardiac sensor linked to a laptop computer. A more recent feasibility RCT (N=40) successfully delivered ADIE to patients with complex physical conditions in their homes, via a new digital platform HeartRater:Clinical (using a computer tablet + heartbeat sensor + software) with online therapist guidance. This project aims to improve the accessibility, inclusivity, and engagement of ADIE as a therapy for anxiety in adults, notably those who do not benefit from standard treatments, such as autistic adults and those with physical health problems. With PPI, this project will co-produce an optimized version of HeartRater:Clinical to deliver ADIE as a standalone software-guided therapy for patients referred to IAPT services: Firstly, ECG will replace optical heartbeat sensors to improve signal reliability in patients with poor peripheral circulation and/or darker skin. Secondly, the user-interface will be optimized for software-guided administration, with gamification to enhance engagement. Next, a Phase 2a clinical trial will test proof-of-concept feasibility of HeartRater:Clinical/ADIE as a 'low intensity' self-administered, software-guided standalone therapy, relative to 'high intensity' therapist-guided use, with feasibility, clinical, qualitative and evaluation process outcomes.Finally, we will pave the way for implementing HeartRater:Clinical in the NHS. We will secure intellectual property rights, and with support from expert partners, a business plan will map pathways for commercialisation, including further funded research (e.g. Health Technology Assessment (HTA) NHS RCT) with health economic evaluation.