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.
| Original language | English |
|---|---|
| Article number | 893 |
| Pages (from-to) | 893-893 |
| Number of pages | 1 |
| Journal | Trials |
| Volume | 21 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 28 Oct 2020 |
Funding
The authors want to express their gratitude to the funding bodies, the European Union by means of the European Commission’s Horizon 2020 research programme and the Australian government, for being provided with the financial capacity to conduct the ImpleMentAll study. We thank the ImpleMentAll consortium for every individual contribution and team effort and for bringing together the required expertise, experience, and organizational capacity to make this study a success. Specifically, we thank the local research and implementation teams, the internal Scientific Steering Committee, and the External Advisory Board for their input in designing the ImpleMentAll study. We remember Dr. Jeroen Ruwaard. His unexpected death (16 July 2019) leaves behind an inexpressible void, to his family, his friends, close colleagues, the ImpleMentAll consortium, and the wider scientific and mental health community. Jeroen’s involvement with the study and mentorship was indispensable and 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, the development of the ItFits-toolkit , trial data management, and ethics. Science and data for the benefit of mental health care were Jeroen’s passion, and he acted as the senior methodologist of the study: better one number well defined than a bucket full of noise. We want to express our gratitude towards Jeroen for the effort he made in realizing this study. ImpleMentAll consortium: Adriaan Hoogendoorn 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 Nielsen 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 Leboyeer Martine Pool 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 Tim Rapley Tracy Finch Ulrich Hegerl Virginie Tsilibaris Wissam Elhage Ylenia Sacco Monitored email address for group correspondence: [email protected]
| Funders | Funder number |
|---|---|
| Batterham Pia Driessen Pierre Michel Llorca Rhonda Wilson Ricardo Araya Robin Kok Sebastian Potthoff Sergi García Redondo Sevim Mustafa Tim Rapley Tracy Finch Ulrich Hegerl Virginie Tsilibaris Wissam | |
| Horizon 2020 Framework Programme | |
| European Commission |
Keywords
- Determinants of practice
- Implementation strategies
- Internet-delivered Cognitive Behavioural Therapy
- Mental health
- Normalization
- SWT
- Stepped wedge trial design
- Tailored implementation
- eHealth
- iCBT
