Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam, Amsterdam, The Netherlands.
Amsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.
Trials. 2020 Oct 28;21(1):893. doi: 10.1186/s13063-020-04686-4.
Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. However, the use of these interventions in routine care is limited. The international ImpleMentAll study is funded by the European Union's Horizon 2020 programme. It is concerned with studying and improving methods for implementing evidence-based iCBT services for common mental disorders in routine mental health care. A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts. This study investigates the effectiveness of the ItFits-toolkit by comparing it to implementation-as-usual activities.
A stepped wedge cluster randomized controlled trial (SWT) design will be applied. Over a trial period of 30 months, the ItFits-toolkit will be introduced sequentially in twelve routine mental health care organizations in primary and specialist care across nine countries in Europe and Australia. Repeated measures are applied to assess change over time in the outcome variables. The effectiveness of the ItFits-toolkit will be assessed in terms of the degree of normalization of the use of the iCBT services. Several exploratory outcomes including uptake of the iCBT services will be measured to feed the interpretation of the primary outcome. Data will be collected via a centralized data collection system and analysed using generalized linear mixed modelling. A qualitative process evaluation of routine implementation activities and the use of the ItFits-toolkit will be conducted within this study.
The ImpleMentAll study is a large-scale international research project designed to study the effectiveness of tailored implementation. Using a SWT design that allows to examine change over time, this study will investigate the effect of tailored implementation on the normalization of the use of iCBT services and their uptake. It will provide a better understanding of the process and methods of tailoring implementation strategies. If found effective, the ItFits-toolkit will be made accessible for mental health care service providers, to help them overcome their context-specific implementation challenges.
ClinicalTrials.gov NCT03652883 . Retrospectively registered on 29 August 2018.
基于互联网的认知行为疗法（iCBT）已被证实对治疗常见精神障碍有效。然而，这些干预措施在常规护理中的应用却很有限。国际 ImpleMentAll 研究由欧盟地平线 2020 计划资助。该研究关注于研究和改进将基于证据的 iCBT 服务应用于常规精神卫生保健中治疗常见精神障碍的方法。一个数字化的实施工具包（ItFits-toolkit）将被引入精神卫生保健机构，旨在促进在当地环境中持续实施 iCBT 服务。本研究通过将 ItFits-toolkit 与常规实施活动进行比较，来评估该工具包的有效性。
将采用逐步楔形集群随机对照试验（SWT）设计。在 30 个月的试验期间，ItFits-toolkit 将在欧洲和澳大利亚的 9 个国家的初级和专科保健中的 12 个常规精神卫生保健机构中顺序引入。采用重复测量来评估随时间变化的结果变量的变化。将根据 iCBT 服务使用的规范化程度来评估 ItFits-toolkit 的有效性。还将测量包括 iCBT 服务采用度在内的几个探索性结果，以对主要结果进行解释。数据将通过集中数据收集系统收集，并使用广义线性混合模型进行分析。在本研究中，还将对常规实施活动和 ItFits-toolkit 的使用进行定性的过程评估。
ImpleMentAll 研究是一项大型国际研究项目，旨在研究定制实施的有效性。该研究采用 SWT 设计，可以随时间检查变化，将调查定制实施对 iCBT 服务使用规范化及其采用度的影响。它将更好地理解定制实施策略的过程和方法。如果被证明有效，ItFits-toolkit 将可供精神卫生保健服务提供者使用，以帮助他们克服特定于环境的实施挑战。
ClinicalTrials.gov NCT03652883。于 2018 年 8 月 29 日进行了回顾性注册。
