Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial
Authors: Vis Christiaan , Schuurmans Josien , Aouizerate Bruno , Atipei Craggs Mette , Batterham Philip , Bührmann Leah , Calear Alison , Cerga Pashoja Arlinda , Christensen Helen , Dozeman Els , Duedal Pedersen Claus , Ebert David Daniel , Etzelmueller Anne , Fanaj Naim , Finch Tracy L , Hanssen Denise , Hegerl Ulrich , Hoogendoorn Adriaan , Mathiasen Kim , May Carl , Meksi Andia , Mustafa Sevim , O'Dea Bridianne , Oehler Caroline , Piera-Jiménez Jordi , Potthoff Sebastian , Qirjako Gentiana , Rapley Tim , Rosmalen Judith , Sacco Ylenia , Samalin Ludovic , Skjoth Mette Maria , Tarp Kristine , Titzler Ingrid , Van der Eycken Erik , van Genugten Claire Rosalie , Whitton Alexis , Zanalda Enrico , Smit Jan H , Riper Heleen 
Published: December 2022

Background
Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary.

Objective
This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia.

Methods
A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit.

Results
In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend 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 the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice.

Trial Registration
ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883

International Registered Report Identifier (IRRID)
RR2-10.1186/s13063-020-04686-4