Conclusions
Rhonda Wilson, death, Nicole Cockayne, Robin, CM, Andia
BRUCE, MARION, WRIGHT, MAY, MOHR, DER
The ItFits-toolkit had a small significant effect on normalization levels in mental health service providers. The toolkit did not change the uptake of iCBT by patients, and implementers did not spend more time using the toolkit in comparison with their usual ways of implementing iCBT services. Implementers generally regarded the ItFits-toolkit as usable and were satisfied with it. Although these findings are in line with expert-driven models of tailored implementation, they warrant modesty regarding the effectiveness of self-guided tailored implementation. Nevertheless, there is practical utility for implementers and clinical decision makers in self-guided tailored implementation of iCBT services in routine mental health care using the ItFits-toolkit.The authors would like to thank all implementers and service providers who participated in this study. The authors would also like to thank all ImpleMentAll consortium members for their nonauthor contributions. Specifically, the authors would like to thank the local research and implementation teams, the internal Scientific Steering Committee, and the External Advisory Board for their input in designing and executing the study. Members of the ImpleMentAll consortium were Adriaan Hoogendoorn, Ainslie O’Connor, Alexis Whitton, Alison Calear, Andia Meksi, Anna Sofie Rømer, Anne Etzelmüller, Antoine Yrondi, Arlinda Cerga-Pashoja, Besnik Loshaj, Bridianne O’Dea, Bruno Aouizerate, Camilla Stryhn, Carl May, Carmen Ceinos, Caroline Oehler, Catherine Pope, Christiaan Vis, Christine Marking, Claire van Genugten, Claus Duedal Pedersen, Corinna Gumbmann, Dana Menist, David Daniel Ebert, Denise Hanssen, Elena Heber, Els Dozeman, Emilie Brysting, Emmanuel Haffen, Enrico Zanalda, Erida Nelaj, Erik Van der Eycken, Eva Fris, Fiona Shand, Gentiana Qirjako, Géraldine Visentin, Heleen Riper, Helen Christensen, Ingrid Titzler, Isabel Weber, Isabel Zbukvic, Jeroen Ruwaard, Jerome Holtzmann, Johanna Freund, Johannes H Smit, Jordi Piera-Jiménez, Josep Penya, Josephine Kreutzer, Josien Schuurmans, Judith Rosmalen, Juliane Hug, Kim Mathiasen, Kristian Kidholm, Kristine Tarp, Leah Bührmann, Linda Lisberg, Ludovic Samalin, Maite Arrillaga, Margot Fleuren, Maria Chovet, Marion Leboyer, Mette Atipei Craggs, Mette Maria Skjøth, Naim Fanaj, Nicole Cockayne, Philip J Batterham, Pia Driessen, Pierre Michel Llorca, Rhonda Wilson, Ricardo Araya, Robin Kok, Sebastian Potthoff, Sergi García Redondo, Sevim Mustafa, Søren Lange Nielsen, Tim Rapley, Tracy Finch, Ulrich Hegerl, Virginie Tsilibaris, Wissam Elhage, and Ylenia Sacco. Members of the internal Scientific Steering Committee were professor Dr Heleen Riper (chair), professor Dr David Ebert, professor Dr Kristian Kidholm, professor Dr Marion Leboyer, professor Dr Carl May, Claus Duedal Pedersen (observer), professor Dr Johannes H Smit, and professor Dr Ulrich Hegerl. Members of the External Advisory Board were Dr Bianca Albers, Mr Bruce Whitear, Mr Chris Wright, Mr Clayton Hamilton, professor Dr David Mohr, professor Dr Dean L Fixsen, professor Dr Elizabeth Murray, professor Dr Genc Burazeri, Mr Hobbe Jan Hiemstra, Mr John Crawford, professor Dr Levente Kriston, Mr Mark Bloemendaal, Dr Markus Moessner, professor Dr Nick Titov, Dr Richardo Gusmao, Mrs Simone Gynnemo, Dr Vicente Traver Salcedo, and Mrs Yammie Fishel. The authors remember Dr Jeroen Ruwaard. His death (July 16, 2019) overwhelmed the authors. Jeroen’s involvement with the study was essential, from drafting the first ideas for the grant application and writing the full proposal to providing the methodological and statistical foundations for the stepped-wedge trial design, trial data management, and ethics. Let’s get one number right was his motto, and that is what the authors did. The authors want to express their gratitude toward Jeroen for the effort he made in realizing this study. This study was funded by the European Union’s Horizon 2020 research and innovation program under grant agreement 733025 and by the National Health and Medical Research Council EU-program by the Australian Government (grant 1142363). The funding bodies had no influence on the design of the study.Authors' Contributions: CV, JS, AE, JPJ, LB, TLF, TR, CM, JHS, and HR designed this study. CDP, KM, MAC, MMS, and CV managed the project and stakeholder involvement at the project level, with CV coordinating the science. DDE, UH, CDP, CM, and JHS were part of the Scientific Steering Committee, which was chaired by HR. ED, CvG, JPJ, DDE, IT, UH, CO, PB, AC, BOD, AW, HC, JR, DH, EZ, YS, BA, LS, KT, KM, NF, SM, AM, GQ, and ACP represented the local study sites. EvdE represented the patient perspective. JS and CvG managed the trial centrally. CV, TR, TLF, SP, LB, CM, and JPJ developed the ItFits-toolkit. CV, JPJ, and LB provided the introductory training and technical support for the ItFits-toolkit users. The analysis was performed by CV, AH, CvG, and JS. CV wrote the manuscript. All authors reviewed, provided input, and approved the final manuscript.Conflicts of Interest: DDE has served as a consultant to/on the scientific advisory boards of Sanofi, Novartis, Minddistrict, Lantern, Schoen Kliniken, Ideamed and German health insurance companies (BARMER, Techniker Krankenkasse) and a number of federal chambers for psychotherapy. He is also shareholder of GET.ON Institut für Online Gesundheitstrainings GmbH für Gesundheitstrainings online GmbH (HelloBetter), which aims to implement scientific findings related to digital health interventions into routine care. LS has received postgraduate Continuing Medical Education–related honoraria and served as consultant for Janssen, Lundbeck, Otsuka and Sanofi with no financial or other relationship relevant to the subject of this article.Primary outcome information—Normalization Measure Development.Secondary outcome—uptake and effort.Secondary outcome—effort.CONSORT-eHEALTH checklist (V 1.6.2).