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
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 con...
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| Format: | Article |
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BMC
2020-10-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-020-04686-4 |
| _version_ | 1818551424189988864 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Leah Bührmann |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-12-12T08:59:42Z |
| format | Article |
| id | doaj.art-130ce3a0016645cdb094428cc38bc1b0 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-12T08:59:42Z |
| publishDate | 2020-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-130ce3a0016645cdb094428cc38bc1b02022-12-22T00:29:52ZengBMCTrials1745-62152020-10-0121111510.1186/s13063-020-04686-4Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trialLeah Bührmann0Josien Schuurmans1Jeroen Ruwaard2Margot Fleuren3Anne Etzelmüller4Jordi Piera-Jiménez5Tracy Finch6Tim Rapley7Sebastian Potthoff8Bruno Aouizerate9Philip J. Batterham10Alison Calear11Helen Christensen12Claus Duedal Pedersen13David Daniel Ebert14Erik Van der Eycken15Naim Fanaj16Claire van Genugten17Denise Hanssen18Ulrich Hegerl19Juliane Hug20Annet Kleiboer21Kim Mathiasen22Carl May23Sevim Mustafa24Caroline Oehler25Arlinda Cerga-Pashoja26Catherine Pope27Gentiana Qirjako28Judith Rosmalen29Ylenia Sacco30Ludovic Samalin31Mette Maria Skjøth32Kristine Tarp33Ingrid Titzler34Enrico Zanalda35Isabel Zbukvic36Johannes H. Smit37Heleen Riper38Christiaan Vis39on behalf of the ImpleMentAll consortiumDepartment of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU AmsterdamAmsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research InstituteAmsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research InstituteDepartment of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU AmsterdamDepartment of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU AmsterdamDepartment of Research and Innovation, Badalona Serveis AssistencialsDepartment of Nursing, Midwifery and Health, Northumbria UniversityDepartment of Social Work, Education and Community Wellbeing, Northumbria UniversityFaculty of Health and Life Sciences, Northumbria UniversityFondation FondaMentalCentre for Mental Health Research, Research School of Population Health, The Australian National UniversityCentre for Mental Health Research, Research School of Population Health, The Australian National UniversityBlack Dog Institute, University of New South WalesCentre for Innovative Medical Technology, Odense University HospitalDepartment of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU AmsterdamGAMIAN EuropeMental Health Center PrizrenAmsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research InstituteUniversity Medical Center Groningen, Interdisciplinary Center for Psychopathology and Emotion Regulation, University of GroningenDepartment of Psychiatry, Psychosomatics and Psychotherapy, Goethe-Universität FrankfurtEuropean Alliance Against Depression e.V.Department of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU AmsterdamResearch Unit for Depression and Anxiety, Aarhus University HospitalFaculty of Public Health and Policy, London School of Hygiene and Tropical MedicineMental Health Center PrizrenStiftung Deutsche DepressionshilfeDepartment of Population Health, London School of Hygiene & Tropical MedicineNuffield Department of Primary Care Health Sciences, University of OxfordDepartment of Public Health, Faculty of Medicine, University of MedicineUniversity Medical Center Groningen, Interdisciplinary Center for Psychopathology and Emotion Regulation, University of GroningenDipartimento di Salute Mentale, Azienda Sanitaria Locale Torino 3Fondation FondaMentalCentre for Innovative Medical Technology, Odense University HospitalCentre for TelepsychiatryGET.ON InstituteDipartimento di Salute Mentale, Azienda Sanitaria Locale Torino 3OrygenAmsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Public Health Research InstituteDepartment of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU AmsterdamDepartment of Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement Sciences, VU AmsterdamAbstract 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 2018http://link.springer.com/article/10.1186/s13063-020-04686-4Tailored implementationNormalizationImplementation strategiesDeterminants of practiceeHealthMental health |
| spellingShingle | 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 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 Trials Tailored implementation Normalization Implementation strategies Determinants of practice eHealth Mental health |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Tailored implementation Normalization Implementation strategies Determinants of practice eHealth Mental health |
| url | http://link.springer.com/article/10.1186/s13063-020-04686-4 |
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