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,
on behalf of the ImpleMentAll consortium
Affiliations
Leah Bührmann
Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam
Josien Schuurmans
Amsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research Institute
Jeroen Ruwaard
Amsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research Institute
Margot Fleuren
Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam
Anne Etzelmüller
Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam
Jordi Piera-Jiménez
Department of Research and Innovation, Badalona Serveis Assistencials
Tracy Finch
Department of Nursing, Midwifery and Health, Northumbria University
Tim Rapley
Department of Social Work, Education and Community Wellbeing, Northumbria University
Sebastian Potthoff
Faculty of Health and Life Sciences, Northumbria University
Bruno Aouizerate
Fondation FondaMental
Philip J. Batterham
Centre for Mental Health Research, Research School of Population Health, The Australian National University
Alison Calear
Centre for Mental Health Research, Research School of Population Health, The Australian National University
Helen Christensen
Black Dog Institute, University of New South Wales
Claus Duedal Pedersen
Centre for Innovative Medical Technology, Odense University Hospital
David Daniel Ebert
Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam
Erik Van der Eycken
GAMIAN Europe
Naim Fanaj
Mental Health Center Prizren
Claire van Genugten
Amsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research Institute
Denise Hanssen
University Medical Center Groningen, Interdisciplinary Center for Psychopathology and Emotion Regulation, University of Groningen
Ulrich Hegerl
Department of Psychiatry, Psychosomatics and Psychotherapy, Goethe-Universität Frankfurt
Juliane Hug
European Alliance Against Depression e.V.
Annet Kleiboer
Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam
Kim Mathiasen
Research Unit for Depression and Anxiety, Aarhus University Hospital
Carl May
Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine
Sevim Mustafa
Mental Health Center Prizren
Caroline Oehler
Stiftung Deutsche Depressionshilfe
Arlinda Cerga-Pashoja
Department of Population Health, London School of Hygiene & Tropical Medicine
Catherine Pope
Nuffield Department of Primary Care Health Sciences, University of Oxford
Gentiana Qirjako
Department of Public Health, Faculty of Medicine, University of Medicine
Judith Rosmalen
University Medical Center Groningen, Interdisciplinary Center for Psychopathology and Emotion Regulation, University of Groningen
Ylenia Sacco
Dipartimento di Salute Mentale, Azienda Sanitaria Locale Torino 3
Ludovic Samalin
Fondation FondaMental
Mette Maria Skjøth
Centre for Innovative Medical Technology, Odense University Hospital
Kristine Tarp
Centre for Telepsychiatry
Ingrid Titzler
GET.ON Institute
Enrico Zanalda
Dipartimento di Salute Mentale, Azienda Sanitaria Locale Torino 3
Isabel Zbukvic
Orygen
Johannes H. Smit
Amsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research Institute
Heleen Riper
Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam
Christiaan Vis
Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU Amsterdam
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
