Anxiety is common in autistic adults and significantly limits everyday opportunities and quality of life. Evidence-based psychological therapies offered by mental health services often fail to meet the needs of autistic adults. The development of appropriate treatments for mental health conditions and, in particular, anxiety has been identified as a key priority by the autism community. The Personalised Anxiety Treatment–Autism (PAT-A©) trial aims to address this need by investigating the feasibility and acceptability of delivering an individualised psychological treatment for anxiety experienced by autistic adults. This is a pilot randomised controlled feasibility trial. Up to 40 autistic adults with clinically diagnosed anxiety will be randomised into one of two groups (either the PAT-A© intervention or Current Clinical Services Plus two emotional literacy skills sessions). Before randomisation, participants will receive a detailed clinical assessment to inform formulation and guide anxiety treatment. As part of the baseline assessment participants will also identify two personally important ‘target situations’ that cause significant anxiety and impact upon their daily life. Based upon the formulation and identified target situations, participants randomised to the PAT-A© intervention will receive up to 12 individualised, one-to-one therapy sessions. Initial emotional literacy training sessions will be followed by a bespoke, modular, needs-based treatment approach utilising one or more of the following approaches: Mindfulness, Coping with Uncertainty in Everyday Situations (CUES), social anxiety and graded exposure within Virtual Reality Environments. Participants in the control arm will receive two psycho-educational sessions focussing on understanding and describing emotions and be signposted to healthcare provision as required. Data will be collected through quantitative and qualitative methods. This feasibility pilot trial serves as the first stage in the development and evaluation of a manualised personalised, evidence-based psychological therapy treatment for anxiety in autistic adults. Study outcomes will be used to inform an application for a fully powered multi-site intervention trial of adults and young people. ISRCTN, ID: 15881562. Retrospectively registered on 9 August 2019.

中文翻译：

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治疗自闭症成人的焦虑：个性化焦虑治疗自闭症 (PAT-A©) 试点随机对照可行性试验的研究方案


焦虑在自闭症成人中很常见，并严重限制了日常机会和生活质量。心理健康服务提供的循证心理治疗往往无法满足自闭症成人的需求。自闭症群体已将开发针对心理健康状况，特别是焦虑症的适当治疗方法作为首要任务。自闭症个性化焦虑治疗 (PAT-A©) 试验旨在通过调查针对自闭症成人所经历的焦虑提供个性化心理治疗的可行性和可接受性来满足这一需求。这是一项随机对照可行性试验。最多 40 名经临床诊断患有焦虑症的自闭症成人将被随机分为两组（PAT-A© 干预或当前临床服务加上两次情绪素养技能课程）。在随机分组之前，参与者将接受详细的临床评估，以告知制定方案并指导焦虑治疗。作为基线评估的一部分，参与者还将确定两个对个人重要的“目标情况”，这些情况会导致严重的焦虑并影响他们的日常生活。根据制定和确定的目标情况，随机接受 PAT-A© 干预的参与者将接受最多 12 次个性化的一对一治疗课程。在最初的情感素养培训课程之后，将采用定制的、模块化的、基于需求的治疗方法，采用以下一种或多种方法：正念、应对日常情况的不确定性 (CUES)、社交焦虑和虚拟现实环境中的分级暴露。 控制臂的参与者将接受两次心理教育课程，重点是理解和描述情绪，并根据需要提供医疗保健服务。将通过定量和定性方法收集数据。这项可行性试点试验是开发和评估针对自闭症成人焦虑症的手动个性化、循证心理治疗的第一阶段。研究结果将用于为成人和年轻人进行全面多中心干预试验的申请提供信息。 ISRCTN，ID：15881562。追溯注册日期：2019 年 8 月 9 日。