Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trial

Leah Bührmann, Josien Schuurmans, Jeroen Ruwaard, Margot Fleuren, Anne Etzelmüller, Jordi Piera-Jiménez, Tracy Finch, Tim Rapley, Sebastian Potthoff, Bruno Aouizerate, Philip J Batterham, Alison Calear, Helen Christensen, Claus Duedal Pedersen, David Daniel Ebert, Erik Van der Eycken, Naim Fanaj, Claire van Genugten, Denise Hanssen, Ulrich Hegerl, Juliane Hug, Annet Kleiboer, Kim Mathiasen, Carl May, Sevim Mustafa, Caroline Oehler, Arlinda Cerga-Pashoja, Catherine Pope, Gentiana Qirjako, Judith Rosmalen, Ylenia Sacco, Ludovic Samalin, Mette Maria Skjøth, Kristine Tarp, Ingrid Titzler, Enrico Zanalda, Isabel Zbukvic, Johannes H Smit, Heleen Riper, Christiaan Vis, ImpleMentAll consortium, Alison Calear, Andia Meksi, Anna Sofie Rømer, Anne Etzelmüller, Antoine Yrondi, Arlinda Cerga-Pashoja, Bridianne O'Dea, Bruno Aouizerate, Carl May, Carmen Ceinos, Caroline Oehler, Catherine Pope, Christiaan Vis, Claire van Genugten, Claus Duedal Pedersen, Corinna Gumbmann, David Daniel Ebert, Denise Hanssen, Els Dozeman, Enrico Zanalda, Erik Van der Eycken, Eva Fris, Gentiana Qirjako, Géraldine Visentin, Heleen Riper, Helen Christensen, Ingrid Titzler, Isabel Zbukvic, Jeroen Ruwaard, Johanna Freund, Johannes H Smit, Jordi Piera-Jiménez, Josep Penya, Josien Schuurmans, Judith Rosmalen, Juliane Hug, Kim Mathiasen, Kristian Kidholm, Kristine Tarp, Leah Bührmann, Ludovic Samalin, Maite Arrillaga, Margot Fleuren, Marion Leboyeer, Martine Pool, Mette Atipei Craggs, Mette Maria Skjøth, Naim Fanaj, Philip J Batterham, Pia Driessen, Robin Kok, Sebastian Potthoff, Sergi García Redondo, Sevim Mustafa, Tim Rapley, Tracy Finch, Ulrich Hegerl, Ylenia Sacco, Leah Bührmann, Josien Schuurmans, Jeroen Ruwaard, Margot Fleuren, Anne Etzelmüller, Jordi Piera-Jiménez, Tracy Finch, Tim Rapley, Sebastian Potthoff, Bruno Aouizerate, Philip J Batterham, Alison Calear, Helen Christensen, Claus Duedal Pedersen, David Daniel Ebert, Erik Van der Eycken, Naim Fanaj, Claire van Genugten, Denise Hanssen, Ulrich Hegerl, Juliane Hug, Annet Kleiboer, Kim Mathiasen, Carl May, Sevim Mustafa, Caroline Oehler, Arlinda Cerga-Pashoja, Catherine Pope, Gentiana Qirjako, Judith Rosmalen, Ylenia Sacco, Ludovic Samalin, Mette Maria Skjøth, Kristine Tarp, Ingrid Titzler, Enrico Zanalda, Isabel Zbukvic, Johannes H Smit, Heleen Riper, Christiaan Vis, ImpleMentAll consortium, Alison Calear, Andia Meksi, Anna Sofie Rømer, Anne Etzelmüller, Antoine Yrondi, Arlinda Cerga-Pashoja, Bridianne O'Dea, Bruno Aouizerate, Carl May, Carmen Ceinos, Caroline Oehler, Catherine Pope, Christiaan Vis, Claire van Genugten, Claus Duedal Pedersen, Corinna Gumbmann, David Daniel Ebert, Denise Hanssen, Els Dozeman, Enrico Zanalda, Erik Van der Eycken, Eva Fris, Gentiana Qirjako, Géraldine Visentin, Heleen Riper, Helen Christensen, Ingrid Titzler, Isabel Zbukvic, Jeroen Ruwaard, Johanna Freund, Johannes H Smit, Jordi Piera-Jiménez, Josep Penya, Josien Schuurmans, Judith Rosmalen, Juliane Hug, Kim Mathiasen, Kristian Kidholm, Kristine Tarp, Leah Bührmann, Ludovic Samalin, Maite Arrillaga, Margot Fleuren, Marion Leboyeer, Martine Pool, Mette Atipei Craggs, Mette Maria Skjøth, Naim Fanaj, Philip J Batterham, Pia Driessen, Robin Kok, Sebastian Potthoff, Sergi García Redondo, Sevim Mustafa, Tim Rapley, Tracy Finch, Ulrich Hegerl, Ylenia Sacco

Abstract

Background: Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. However, the use of these interventions in routine care is limited. The international ImpleMentAll study is funded by the European Union's Horizon 2020 programme. It is concerned with studying and improving methods for implementing evidence-based iCBT services for common mental disorders in routine mental health care. A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts. This study investigates the effectiveness of the ItFits-toolkit by comparing it to implementation-as-usual activities.

Methods: A stepped wedge cluster randomized controlled trial (SWT) design will be applied. Over a trial period of 30 months, the ItFits-toolkit will be introduced sequentially in twelve routine mental health care organizations in primary and specialist care across nine countries in Europe and Australia. Repeated measures are applied to assess change over time in the outcome variables. The effectiveness of the ItFits-toolkit will be assessed in terms of the degree of normalization of the use of the iCBT services. Several exploratory outcomes including uptake of the iCBT services will be measured to feed the interpretation of the primary outcome. Data will be collected via a centralized data collection system and analysed using generalized linear mixed modelling. A qualitative process evaluation of routine implementation activities and the use of the ItFits-toolkit will be conducted within this study.

Discussion: The ImpleMentAll study is a large-scale international research project designed to study the effectiveness of tailored implementation. Using a SWT design that allows to examine change over time, this study will investigate the effect of tailored implementation on the normalization of the use of iCBT services and their uptake. It will provide a better understanding of the process and methods of tailoring implementation strategies. If found effective, the ItFits-toolkit will be made accessible for mental health care service providers, to help them overcome their context-specific implementation challenges.

Trial registration: ClinicalTrials.gov NCT03652883 . Retrospectively registered on 29 August 2018.

Keywords: Determinants of practice; Implementation strategies; Internet-delivered Cognitive Behavioural Therapy; Mental health; Normalization; SWT; Stepped wedge trial design; Tailored implementation; eHealth; iCBT.

Conflict of interest statement

Professor Bruno Aouizerate has received honoraria or consulting fees from Janssen-Cilag, Lundbeck, and Lilly. Dr. Samalin has received grants, honoraria, or consulting fees from Janssen-Cilag, Lundbeck, and Otsuka. All other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Process of context-specific tailoring as applied in the ImpleMentAll project
Fig. 2
Fig. 2
Stepped wedge cluster randomized trial design for the ImpleMentAll project
Fig. 3
Fig. 3
Anticipated participant flow. The total number of participants will be calculated by summing up participants across all groups and all measurement waves
Fig. 4
Fig. 4
Flowchart of the ItFits-toolkit
Fig. 5
Fig. 5
Three-step iterative working process for each module to reach consensus among relevant stakeholders

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