Abstract
BackgroundInternet-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.MethodsA 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.DiscussionThe 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.Trial registrationClinicalTrials.gov NCT03652883. Retrospectively registered on 29 August 2018
Highlights
Internet-based Cognitive Behavioural Therapy is found effective in treating common mental disorders
The ImpleMentAll study is a large-scale international research project designed to study the effectiveness of tailored implementation
Using a stepped wedge cluster randomized controlled trial (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 Internet-based Cognitive Behavioural Therapy (iCBT) services and their uptake
Summary
Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. It is concerned with studying and improving methods for implementing evidence-based iCBT services for common mental disorders in routine mental health care. Other studies reported the general motivation and belief of professionals regarding the benefits of iCBT treatments [21, 22], but showed that lack of time, inadequate knowledge of the service, and the need to change habits were an impediment to the uptake of iCBT [22] This is confirmed by a systematic review summarizing the determinants of practice regarding the implementation of Internet-delivered treatments [23]. The review highlighted 37 determinants to implementation on health care system, organizational, professional, and patient level showing that there is a multitude of barriers to overcome in order to implement iCBT successfully in routine practice. Every implementation setting is unique [24]
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