Effectiveness of self-guided tailored implementation strategies in integrating and embedding Internet-based Cognitive Behavioural Therapy in routine mental health care. Results of the ImpleMentAll project. (Preprint)

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BACKGROUND Internet-based Cognitive Behaviour Therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for effective strategies to improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective and tailored implementation is considered as a promising approach. The self-guided ‘Integrated Theory-based Framework for Implementation Tailoring Strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves (1) identifying local barriers, (2) matching selected barriers to implementation strategies, (3) developing an actionable work plan, and (4) applying, monitoring, and adapting where necessary. OBJECTIVE We compared the effectiveness of the ItFits-toolkit with Implementation-As-Usual (IAU) in implementing iCBT in twelve routine mental health care organisations in nine countries. METHODS A stepped-wedge cluster randomised trial design with repeated measures was applied. The total trial period was 30 months. The primary outcome was normalisation of iCBT delivery by service providers (therapists, referrers, IT developers, administrators) measured with the NoMAD as a proxy for implementation success. Three-level linear mixed-effects modelling was applied to estimate the effects. iCBT uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. Perceived satisfaction (CSQ-3), usability (SUS), and impact of the ItFits-toolkit by implementers was assessed to assesses the acceptability of the ItFits-toolkit. RESULTS In total, 456 mental health service providers were included in the study. Compared to IAU, the ItFits-toolkit had a small significant positive effect on normalisation levels in service providers (M=0.09, SD=0.04, p=0.02, Cohen’s d=0.12). Uptake of iCBT by patients was on par with IAU. Compared to IAU, implementers did not spent more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it. CONCLUSIONS The ItFits-toolkit performed better than usual implementation activities in implementing iCBT services in routine practice. However, the effect on normalization levels in mental health service providers was very small. There lies practical utility in the ItFits-toolkit for supporting implementers to develop and apply effective tailored implementation strategies. However, these findings warrant modesty about the effectiveness of self-guided tailored implementation in implementing iCBT services in routine practice. CLINICALTRIAL ClinicalTrials.gov (No. NCT03652883) INTERNATIONAL REGISTERED REPORT RR2-10.1186/s13063-020-04686-4

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