Wells Adrian, Reeves David, Belcher Andrew, Wilson Paul, Doherty Patrick, Capobianco Lora
Division of Psychology and Mental Health, School of Psychological Sciences, Faculty of Biology, Medicine and Health, School of Health Sciences, The University of Manchester, Manchester, United Kingdom.
Research and Innovation, Greater Manchester Mental Health NHS Foundation Trust, National Health Service Foundation, Manchester, United Kingdom.
Front Health Serv. 2024 Oct 17;4:1296596. doi: 10.3389/frhs.2024.1296596. eCollection 2024.
Cardiac rehabilitation (CR) services aim to improve heart disease patients' health and quality of life and reduce the risk of further cardiac events. Depression and anxiety are common among CR patients but psychological treatments have usually had small effects. In contrast, the recent NIHR-funded PATHWAY trial found that group Metacognitive Therapy (MCT) was associated with improvements in anxiety and depression when added to CR and was more effective than usual CR alone. The next stage is to test implementation of MCT within the National Health Service through the creation of a network of CR beacon sites. The study will test the quality of data capture following addition of a new MCT data-field to the national audit of cardiac rehabilitation (NACR), examine level of adoption at sites, examine mental health outcomes benchmarked against usual CR and the PATHWAY data, examine the enablers and barriers to implementation and the expected resource requirements. The study has been registered: NCT05956912 (13th July, 2023).
Beacon sites will be recruited as preliminary adopters of group MCT from NHS CR services in England. A national invitation for expressions of interest from CR services will be issued and those meeting eligibility criteria will be considered for inclusion. Two staff at each site will receive training in MCT, and mixed-methods will be used to address questions concerning the quality of patient data recorded, level of adoption at sites, the characteristics of patients attending MCT, the impact of adding MCT to CR on mental health outcomes, and patient, healthcare staff and commissioner views of barriers/enablers to implementation. Exploration of implementation will be informed by Normalisation Process Theory.
The study will support development of an NHS roll-out strategy, assess the mental health outcomes associated with MCT, examine treatment fidelity in real-world settings, and evaluate revised data collection structures that can be used to assess the impact of national-level implementation.
NCT05956912; 13 July 2023.
心脏康复（CR）服务旨在改善心脏病患者的健康状况和生活质量，并降低再次发生心脏事件的风险。抑郁症和焦虑症在CR患者中很常见，但心理治疗通常效果甚微。相比之下，最近由英国国家卫生研究院（NIHR）资助的PATHWAY试验发现，团体元认知疗法（MCT）在添加到CR中时，与焦虑和抑郁的改善相关，并且比单独的常规CR更有效。下一阶段是通过创建CR示范站点网络，在国民医疗服务体系（NHS）内测试MCT的实施情况。该研究将测试在国家心脏康复审计（NACR）中添加新的MCT数据字段后的数据采集质量，检查各站点的采用水平，对照常规CR和PATHWAY数据检查心理健康结果，检查实施的促进因素和障碍以及预期的资源需求。该研究已注册：NCT05956912（2023年7月13日）。
示范站点将从英格兰NHS的CR服务中招募，作为团体MCT的初步采用者。将向CR服务机构发出全国性的意向表达邀请，符合资格标准的机构将被考虑纳入。每个站点的两名工作人员将接受MCT培训，并采用混合方法来解决有关记录的患者数据质量、站点采用水平、参加MCT的患者特征、将MCT添加到CR对心理健康结果的影响以及患者、医护人员和专员对实施障碍/促进因素的看法等问题。将根据规范化过程理论对实施情况进行探索。
该研究将支持制定NHS推广策略，评估与MCT相关的心理健康结果，检查现实环境中的治疗保真度，并评估可用于评估国家级实施影响的修订后的数据收集结构。
NCT05956912；2023年7月13日。
