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Randomized Controlled Trial
. 2023 Feb 3:25:e41532.
doi: 10.2196/41532.

Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial

Christiaan Vis  1   2   3 , Josien Schuurmans  4 , Bruno Aouizerate  5 , Mette Atipei Craggs  6 , Philip Batterham  7 , Leah Bührmann  8 , Alison Calear  7 , Arlinda Cerga Pashoja  9 , Helen Christensen  10 , Els Dozeman  4 , Claus Duedal Pedersen  11 , David Daniel Ebert  12   13 , Anne Etzelmueller  12   13 , Naim Fanaj  14 , Tracy L Finch  15 , Denise Hanssen  16 , Ulrich Hegerl  17   18 , Adriaan Hoogendoorn  2   4   19 , Kim Mathiasen  6   20 , Carl May  21 , Andia Meksi  22 , Sevim Mustafa  14 , Bridianne O'Dea  23 , Caroline Oehler  17 , Jordi Piera-Jiménez  24   25   26 , Sebastian Potthoff  8 , Gentiana Qirjako  27 , Tim Rapley  8 , Judith Rosmalen  16   28 , Ylenia Sacco  29 , Ludovic Samalin  30   31 , Mette Maria Skjoth  32 , Kristine Tarp  6   20 , Ingrid Titzler  33 , Erik Van der Eycken  34 , Claire Rosalie van Genugten  1   2 , Alexis Whitton  23 , Enrico Zanalda  29 , Jan H Smit  2   19 , Heleen Riper  1   2   19
Affiliations
Randomized Controlled Trial

Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial

Christiaan Vis et al. J Med Internet Res. .

Abstract

Background: Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary.

Objective: This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia.

Methods: A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit.

Results: In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it.

Conclusions: The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice.

Trial registration: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883.

International registered report identifier (irrid): RR2-10.1186/s13063-020-04686-4.

Keywords: common mental health disorders; iCBT; implementation strategies; internet-based cognitive behavioral therapy; mobile phone; tailored implementation.

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Conflict of interest statement

Conflicts of Interest: DDE has served as a consultant to/on the scientific advisory boards of Sanofi, Novartis, Minddistrict, Lantern, Schoen Kliniken, Ideamed and German health insurance companies (BARMER, Techniker Krankenkasse) and a number of federal chambers for psychotherapy. He is also shareholder of GET.ON Institut für Online Gesundheitstrainings GmbH für Gesundheitstrainings online GmbH (HelloBetter), which aims to implement scientific findings related to digital health interventions into routine care. LS has received postgraduate Continuing Medical Education–related honoraria and served as consultant for Janssen, Lundbeck, Otsuka and Sanofi with no financial or other relationship relevant to the subject of this article.

Figures

Figure 1
Figure 1
Stepped-wedge cluster randomized controlled trial design.
Figure 2
Figure 2
Integrated Theory-based Framework for Implementation Tailoring Strategies toolkit (ItFits-toolkit) process flow and main working mechanisms. TiDIER: Template for Intervention Description and Replication.
Figure 3
Figure 3
Mean Normalization Measure Development (NoMAD) score per mental health service delivery organization across time. IAU: implementation-as-usual; ItFits-toolkit: Integrated Theory-based Framework for Implementation Tailoring Strategies toolkit.
See this image and copyright information in PMC

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