TY - JOUR
T1 - Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care
T2 - Results of a Multicenter Stepped-Wedge Cluster Randomized Trial
AU - Vis, Christiaan
AU - Schuurmans, Josien
AU - Aouizerate, Bruno
AU - Atipei Craggs, Mette
AU - Batterham, Philip
AU - Bührmann, Leah
AU - Calear, Alison
AU - Cerga Pashoja, Arlinda
AU - Christensen, Helen
AU - Dozeman, Els
AU - Duedal Pedersen, Claus
AU - Ebert, David Daniel
AU - Etzelmueller, Anne
AU - Fanaj, Naim
AU - Finch, Tracy L.
AU - Hanssen, Denise
AU - Hegerl, Ulrich
AU - Hoogendoorn, Adriaan
AU - Mathiasen, Kim
AU - May, Carl
AU - Meksi, Andia
AU - Mustafa, Sevim
AU - O'Dea, Bridianne
AU - Oehler, Caroline
AU - Piera-Jiménez, Jordi
AU - Potthoff, Sebastian
AU - Qirjako, Gentiana
AU - Rapley, Tim
AU - Rosmalen, Judith
AU - Sacco, Ylenia
AU - Samalin, Ludovic
AU - Skjoth, Mette Maria
AU - Tarp, Kristine
AU - Titzler, Ingrid
AU - Van der Eycken, Erik
AU - van Genugten, Claire Rosalie
AU - Whitton, Alexis
AU - Zanalda, Enrico
AU - Smit, Jan H.
AU - Riper, Heleen
PY - 2023/2/3
Y1 - 2023/2/3
N2 - 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.
AB - 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.
KW - common mental health disorders
KW - iCBT
KW - implementation strategies
KW - internet-based cognitive behavioral therapy
KW - mobile phone
KW - tailored implementation
UR - http://www.scopus.com/inward/record.url?scp=85147458256&partnerID=8YFLogxK
U2 - 10.2196/41532
DO - 10.2196/41532
M3 - Article
C2 - 36735287
AN - SCOPUS:85147458256
SN - 1439-4456
VL - 25
JO - Journal of Medical Internet Research
JF - Journal of Medical Internet Research
M1 - e41532
ER -
