PDF(Pubmed)
Abstract：
BACKGROUND: Recent years have seen a growing interest in the use of digital tools for delivering person-centred mental health care. Experience Sampling Methodology (ESM), a structured diary technique for capturing moment-to-moment variation in experience and behaviour in service users\' daily life, reflects a particularly promising avenue for implementing a person-centred approach. While there is evidence on the effectiveness of ESM-based monitoring, uptake in routine mental health care remains limited. The overarching aim of this hybrid effectiveness-implementation study is to investigate, in detail, reach, effectiveness, adoption, implementation, and maintenance as well as contextual factors, processes, and costs of implementing ESM-based monitoring, reporting, and feedback into routine mental health care in four European countries (i.e., Belgium, Germany, Scotland, Slovakia).
METHODS: In this hybrid effectiveness-implementation study, a parallel-group, assessor-blind, multi-centre cluster randomized controlled trial (cRCT) will be conducted, combined with a process and economic evaluation. In the cRCT, 24 clinical units (as the cluster and unit of randomization) at eight sites in four European countries will be randomly allocated using an unbalanced 2:1 ratio to one of two conditions: (a) the experimental condition, in which participants receive a Digital Mobile Mental Health intervention (DMMH) and other implementation strategies in addition to treatment as usual (TAU) or (b) the control condition, in which service users are provided with TAU. Outcome data in service users and clinicians will be collected at four time points: at baseline (t0), 2-month post-baseline (t1), 6-month post-baseline (t2), and 12-month post-baseline (t3). The primary outcome will be patient-reported service engagement assessed with the service attachment questionnaire at 2-month post-baseline. The process and economic evaluation will provide in-depth insights into in-vivo context-mechanism-outcome configurations and economic costs of the DMMH and other implementation strategies in routine care, respectively.
CONCLUSIONS: If this trial provides evidence on reach, effectiveness, adoption, implementation and maintenance of implementing ESM-based monitoring, reporting, and feedback, it will form the basis for establishing its public health impact and has significant potential to bridge the research-to-practice gap and contribute to swifter ecological translation of digital innovations to real-world delivery in routine mental health care.
BACKGROUND: ISRCTN15109760 (ISRCTN registry, date: 03/08/2022).
METHODS: In this hybrid effectiveness-implementation study, a parallel-group, assessor-blind, multi-centre cluster randomized controlled trial (cRCT) will be conducted, combined with a process and economic evaluation. In the cRCT, 24 clinical units (as the cluster and unit of randomization) at eight sites in four European countries will be randomly allocated using an unbalanced 2:1 ratio to one of two conditions: (a) the experimental condition, in which participants receive a Digital Mobile Mental Health intervention (DMMH) and other implementation strategies in addition to treatment as usual (TAU) or (b) the control condition, in which service users are provided with TAU. Outcome data in service users and clinicians will be collected at four time points: at baseline (t0), 2-month post-baseline (t1), 6-month post-baseline (t2), and 12-month post-baseline (t3). The primary outcome will be patient-reported service engagement assessed with the service attachment questionnaire at 2-month post-baseline. The process and economic evaluation will provide in-depth insights into in-vivo context-mechanism-outcome configurations and economic costs of the DMMH and other implementation strategies in routine care, respectively.
CONCLUSIONS: If this trial provides evidence on reach, effectiveness, adoption, implementation and maintenance of implementing ESM-based monitoring, reporting, and feedback, it will form the basis for establishing its public health impact and has significant potential to bridge the research-to-practice gap and contribute to swifter ecological translation of digital innovations to real-world delivery in routine mental health care.
BACKGROUND: ISRCTN15109760 (ISRCTN registry, date: 03/08/2022).
摘要：
背景：近年来，人们对使用数字工具提供以人为本的精神卫生保健越来越感兴趣。经验抽样方法(ESM)，一种结构化的日记技术，用于捕获服务用户日常生活中体验和行为的时刻变化，反映了实施以人为本方法的一个特别有希望的途径。虽然有证据表明基于ESM的监测的有效性，在常规精神卫生保健中的摄取仍然有限。这项混合有效性实施研究的总体目标是调查，在细节上,reach,有效性,收养,实施，和维护以及环境因素，进程,以及实施基于ESM的监控的成本，reporting,并反馈给四个欧洲国家的常规精神卫生保健(即，比利时,德国,苏格兰,斯洛伐克）。
方法：在这项混合有效性实施研究中，一个平行组，评估员-盲，将进行多中心集群随机对照试验(cRCT)，结合过程和经济评价。在cRCT中，在四个欧洲国家的八个地点的24个临床单位（作为群集和随机化单位）将使用不平衡的2：1比例随机分配到两个条件之一：（a）实验条件，参与者除了接受常规治疗（TAU）或（b）控制条件外，还接受数字移动心理健康干预（DMMH）和其他实施策略，其中为服务用户提供TAU。服务用户和临床医生的结果数据将在四个时间点收集：在基线（t0），基线后2个月（t1），基线后6个月(t2)，和基线后12个月（t3）。主要结果将是患者报告的服务参与度，在基线后2个月使用服务附件问卷进行评估。该过程和经济评估将深入了解DMMH的体内背景-机制-结果配置和经济成本以及常规护理中的其他实施策略，分别。
结论：如果本试验提供了可及的证据，有效性,收养,实施和维护实施基于ESM的监控，reporting,和反馈，它将成为建立其公共卫生影响的基础，并具有弥合研究与实践差距的巨大潜力，并有助于将数字创新更快地生态转化为现实世界的常规精神卫生保健服务。
背景：ISRCTN15109760（ISRCTN注册表，日期：2022年8月3日）。
方法：在这项混合有效性实施研究中，一个平行组，评估员-盲，将进行多中心集群随机对照试验(cRCT)，结合过程和经济评价。在cRCT中，在四个欧洲国家的八个地点的24个临床单位（作为群集和随机化单位）将使用不平衡的2：1比例随机分配到两个条件之一：（a）实验条件，参与者除了接受常规治疗（TAU）或（b）控制条件外，还接受数字移动心理健康干预（DMMH）和其他实施策略，其中为服务用户提供TAU。服务用户和临床医生的结果数据将在四个时间点收集：在基线（t0），基线后2个月（t1），基线后6个月(t2)，和基线后12个月（t3）。主要结果将是患者报告的服务参与度，在基线后2个月使用服务附件问卷进行评估。该过程和经济评估将深入了解DMMH的体内背景-机制-结果配置和经济成本以及常规护理中的其他实施策略，分别。
结论：如果本试验提供了可及的证据，有效性,收养,实施和维护实施基于ESM的监控，reporting,和反馈，它将成为建立其公共卫生影响的基础，并具有弥合研究与实践差距的巨大潜力，并有助于将数字创新更快地生态转化为现实世界的常规精神卫生保健服务。
背景：ISRCTN15109760（ISRCTN注册表，日期：2022年8月3日）。
