. 2020 Oct 28;21(1):893.

doi: 10.1186/s13063-020-04686-4.

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^{1

2}, Josien Schuurmans^{3

4}, Jeroen Ruwaard^{3

4}, Margot Fleuren^{5

3

6}, Anne Etzelmüller^{5

3

7}, Jordi Piera-Jiménez⁸, Tracy Finch⁹, Tim Rapley¹⁰, Sebastian Potthoff¹¹, Bruno Aouizerate^{12

13}, Philip J Batterham¹⁴, Alison Calear¹⁴, Helen Christensen¹⁵, Claus Duedal Pedersen¹⁶, David Daniel Ebert^{5

7

17}, Erik Van der Eycken¹⁸, Naim Fanaj^{19

20}, Claire van Genugten^{3

4}, Denise Hanssen²¹, Ulrich Hegerl²², Juliane Hug²³, Annet Kleiboer^{5

3}, Kim Mathiasen²⁴, Carl May²⁵, Sevim Mustafa^{19

26}, Caroline Oehler²⁷, Arlinda Cerga-Pashoja²⁸, Catherine Pope²⁹, Gentiana Qirjako³⁰, Judith Rosmalen²¹, Ylenia Sacco³¹, Ludovic Samalin^{12

32}, Mette Maria Skjøth^{16

33}, Kristine Tarp³⁴, Ingrid Titzler^{7

17}, Enrico Zanalda³¹, Isabel Zbukvic^{35

36}, Johannes H Smit^{3

4}, Heleen Riper^{5

3

4}, Christiaan Vis^{5

3}; ImpleMentAll consortium

Collaborators, Affiliations

Collaborators

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

Affiliations

¹ Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam, Amsterdam, The Netherlands. l.buhrmann@vu.nl.
² Amsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands. l.buhrmann@vu.nl.
³ Amsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.
⁴ Department of Research and Innovation, GGZ inGeest Specialized Mental Health Care, Amsterdam, The Netherlands.
⁵ Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam, Amsterdam, The Netherlands.
⁶ Dutch Nurses Association, Utrecht, The Netherlands.
⁷ GET.ON Institute, Hamburg, Germany.
⁸ Department of Research and Innovation, Badalona Serveis Assistencials, Badalona, Spain.
⁹ Department of Nursing, Midwifery and Health, Northumbria University, Newcastle upon Tyne, UK.
¹⁰ Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle upon Tyne, UK.
¹¹ Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.
¹² Fondation FondaMental, Creteil, France.
¹³ Regional Reference Center for the Management and Treatment of Anxiety and Depressive Disorders, Expert Center for Treatment-Resistant Depression, CH Charles Perrens, University of Bordeaux, Bordeaux, France.
¹⁴ Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.
¹⁵ Black Dog Institute, University of New South Wales, Randwick, Australia.
¹⁶ Centre for Innovative Medical Technology, Odense University Hospital, Odense, Denmark.
¹⁷ Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University of Erlangen-Nuremberg, Erlangen, Germany.
¹⁸ GAMIAN Europe, Brussels, Belgium.
¹⁹ Mental Health Center Prizren, Prizren, Kosovo.
²⁰ College of Medical Sciences Rezonanca, Prishtina, Kosovo.
²¹ University Medical Center Groningen, Interdisciplinary Center for Psychopathology and Emotion Regulation, University of Groningen, Groningen, The Netherlands.
²² Department of Psychiatry, Psychosomatics and Psychotherapy, Goethe-Universität Frankfurt, Frankfurt, Germany.
²³ European Alliance Against Depression e.V., Leipzig, Germany.
²⁴ Research Unit for Depression and Anxiety, Aarhus University Hospital, Aarhus N, Denmark.
²⁵ Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.
²⁶ Faculty of Education, University St. Kliment Ohridski, Bitola, North Macedonia.
²⁷ Stiftung Deutsche Depressionshilfe, Leipzig, Germany.
²⁸ Department of Population Health, London School of Hygiene & Tropical Medicine, London, UK.
²⁹ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
³⁰ Department of Public Health, Faculty of Medicine, University of Medicine, Tirana, Albania.
³¹ Dipartimento di Salute Mentale, Azienda Sanitaria Locale Torino 3, Turin, Italy.
³² Department of Psychiatry, CHU Clermont-Ferrand, University of Clermont Auvergne, Clermont-Ferrand, France.
³³ Danish Centre for Health Economics, Department of Public Health, University of Southern Denmark, Odense, Denmark.
³⁴ Centre for Telepsychiatry, Region of Southern Denmark, Denmark.
³⁵ Orygen, Parkville, Victoria, Australia.
³⁶ Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.

PMID: 33115545
PMCID: PMC7592568
DOI: 10.1186/s13063-020-04686-4

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 et al. Trials. 2020.

. 2020 Oct 28;21(1):893.

doi: 10.1186/s13063-020-04686-4.

Authors

Collaborators

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

Affiliations

¹ Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam, Amsterdam, The Netherlands. l.buhrmann@vu.nl.
² Amsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands. l.buhrmann@vu.nl.
³ Amsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.
⁴ Department of Research and Innovation, GGZ inGeest Specialized Mental Health Care, Amsterdam, The Netherlands.
⁵ Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam, Amsterdam, The Netherlands.
⁶ Dutch Nurses Association, Utrecht, The Netherlands.
⁷ GET.ON Institute, Hamburg, Germany.
⁸ Department of Research and Innovation, Badalona Serveis Assistencials, Badalona, Spain.
⁹ Department of Nursing, Midwifery and Health, Northumbria University, Newcastle upon Tyne, UK.
¹⁰ Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle upon Tyne, UK.
¹¹ Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.
¹² Fondation FondaMental, Creteil, France.
¹³ Regional Reference Center for the Management and Treatment of Anxiety and Depressive Disorders, Expert Center for Treatment-Resistant Depression, CH Charles Perrens, University of Bordeaux, Bordeaux, France.
¹⁴ Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.
¹⁵ Black Dog Institute, University of New South Wales, Randwick, Australia.
¹⁶ Centre for Innovative Medical Technology, Odense University Hospital, Odense, Denmark.
¹⁷ Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University of Erlangen-Nuremberg, Erlangen, Germany.
¹⁸ GAMIAN Europe, Brussels, Belgium.
¹⁹ Mental Health Center Prizren, Prizren, Kosovo.
²⁰ College of Medical Sciences Rezonanca, Prishtina, Kosovo.
²¹ University Medical Center Groningen, Interdisciplinary Center for Psychopathology and Emotion Regulation, University of Groningen, Groningen, The Netherlands.
²² Department of Psychiatry, Psychosomatics and Psychotherapy, Goethe-Universität Frankfurt, Frankfurt, Germany.
²³ European Alliance Against Depression e.V., Leipzig, Germany.
²⁴ Research Unit for Depression and Anxiety, Aarhus University Hospital, Aarhus N, Denmark.
²⁵ Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.
²⁶ Faculty of Education, University St. Kliment Ohridski, Bitola, North Macedonia.
²⁷ Stiftung Deutsche Depressionshilfe, Leipzig, Germany.
²⁸ Department of Population Health, London School of Hygiene & Tropical Medicine, London, UK.
²⁹ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
³⁰ Department of Public Health, Faculty of Medicine, University of Medicine, Tirana, Albania.
³¹ Dipartimento di Salute Mentale, Azienda Sanitaria Locale Torino 3, Turin, Italy.
³² Department of Psychiatry, CHU Clermont-Ferrand, University of Clermont Auvergne, Clermont-Ferrand, France.
³³ Danish Centre for Health Economics, Department of Public Health, University of Southern Denmark, Odense, Denmark.
³⁴ Centre for Telepsychiatry, Region of Southern Denmark, Denmark.
³⁵ Orygen, Parkville, Victoria, Australia.
³⁶ Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.

PMID: 33115545
PMCID: PMC7592568
DOI: 10.1186/s13063-020-04686-4

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.

PubMed Disclaimer

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**
Process of context-specific tailoring as applied in the ImpleMentAll project

**Fig. 2**
Stepped wedge cluster randomized trial design for the ImpleMentAll project

**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**
Flowchart of the *ItFits-toolkit*

**Fig. 5**
Three-step iterative working process for each module to reach consensus among relevant stakeholders

See this image and copyright information in PMC

References

1. Kessler RC, Aguilar-Gaxiola S, Alonso J, Chatterji S, Lee S, Ormel J, et al. The global burden of mental disorders: an update from the WHO World Mental Health (WMH) surveys. Epidemiol Psychiatr Sci. 2009;18(1):23–33. doi: 10.1017/S1121189X00001421. - DOI - PMC - PubMed
1. Ebert DD, Van Daele T, Nordgreen T, Karekla M, Compare A, Zarbo C, Kaehlke F. Internet and mobile-based psychological interventions: Applications, efficacy and potential for improving mental health. A report of the EFPA E-Health Taskforce (vol 23, pg 167, 2018) Eur Psychol. 2018;23(3):269. doi: 10.1027/1016-9040/a000346. - DOI
1. Josephine K, Josefine L, Philipp D, David E, Harald B. Internet- and mobile-based depression interventions for people with diagnosed depression: a systematic review and meta-analysis. J Affect Disord. 2017;223:28–40. doi: 10.1016/j.jad.2017.07.021. - DOI - PubMed
1. Lindefors N, Andersson G, editors. Guided Internet-based treatments in psychiatry. Cham: Springer International Publishing; 2016.
1. Karyotaki E, Riper H, Twisk J, Hoogendoorn A, Kleiboer A, Mira A, et al. Efficacy of self-guided internet-based cognitive behavioral therapy in the treatment of depressive symptoms a meta-analysis of individual participant data. JAMA Psychiatry. 2017;74(4):351–359. doi: 10.1001/jamapsychiatry.2017.0044. - DOI - PubMed

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical