TY - JOUR AU - Vis, Christiaan AU - Schuurmans, Josien AU - Aouizerate, Bruno AU - Atipei Craggs, Mette AU - Batterham, Philip AU - Bührmann, Leah AU - Calear, Alison AU - Cerga Pashoja, Arlinda AU - Christensen, Helen AU - Dozeman, Els AU - Duedal Pedersen, Claus AU - Ebert, David Daniel AU - Etzelmueller, Anne AU - Fanaj, Naim AU - Finch, Tracy L AU - Hanssen, Denise AU - Hegerl, Ulrich AU - Hoogendoorn, Adriaan AU - Mathiasen, Kim AU - May, Carl AU - Meksi, Andia AU - Mustafa, Sevim AU - O'Dea, Bridianne AU - Oehler, Caroline AU - Piera-Jiménez, Jordi AU - Potthoff, Sebastian AU - Qirjako, Gentiana AU - Rapley, Tim AU - Rosmalen, Judith AU - Sacco, Ylenia AU - Samalin, Ludovic AU - Skjoth, Mette Maria AU - Tarp, Kristine AU - Titzler, Ingrid AU - Van der Eycken, Erik AU - van Genugten, Claire Rosalie AU - Whitton, Alexis AU - Zanalda, Enrico AU - Smit, Jan H AU - Riper, Heleen PY - 2023 DA - 2023/2/3 TI - 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 JO - J Med Internet Res SP - e41532 VL - 25 KW - common mental health disorders KW - internet-based cognitive behavioral therapy KW - iCBT KW - implementation strategies KW - tailored implementation KW - mobile phone AB - 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 SN - 1438-8871 UR - https://www.jmir.org/2023/1/e41532 UR - https://doi.org/10.2196/41532 UR - http://www.ncbi.nlm.nih.gov/pubmed/36735287 DO - 10.2196/41532 ID - info:doi/10.2196/41532 ER -