Strengths and Limitations
earthquakes
EVENTS, FIRES
This study was one of the first large-scale international collaborative research projects in which the primary focus was to use implementation science approaches to contribute to the implementation of iCBT services in routine mental health care. A strength of this trial was its high ecological validity. We managed to study a diverse group of implementers and iCBT service providers that were representative of routine care in 12 mental health service organizations in 8 European countries and Australia. Representing routine care mental health service delivery practice, the way in which mental health services were operationalized and delivered, including the clinical focus, guidance modalities, technical platform, and availability of mental health professionals and their experience with cognitive behavioral therapy, varied among the mental health service delivery organizations. A number of unforeseen events, ranging from internal staff turnover to changing legislation and reimbursement models, and natural disasters, such as bush fires, earthquakes, and the COVID-19 pandemic, occurred as they did. All available data were used, and by applying a pragmatic stepped-wedge cluster randomized controlled trial study design with repeated measures and a psychometrically validated implementation outcome measure, the study allowed for these variations to provide an accurate representation of real-world implementation practice. By randomizing the moment of introduction of the ItFits-toolkit in the implementation of mental health organizations, both conditions had an equal chance of being exposed to the events that occurred during the trial. Another strength was the systematic execution of the multisite study protocol within budget and time and with a centralized DCS providing high data quality [Some methodological limitations should be considered when interpreting the results. One aspect was that IAU activities cannot be undone once embarked upon. The results might be influenced by carryover effects and intervention lag effects within the service delivery organizations. Therefore, it was likely that the findings originated from the ItFits-toolkit plus usual implementation activities. Likewise, the effects of the ItFits-toolkit might have become apparent beyond the data collection period. A second methodological limitation relates to outcome normalization, as measured by the NoMAD. This questionnaire was developed with precision and methodological rigor [