PMID- 36735287
OWN - NLM
STAT- MEDLINE
DCOM- 20230207
LR  - 20230220
IS  - 1438-8871 (Electronic)
IS  - 1439-4456 (Print)
IS  - 1438-8871 (Linking)
VI  - 25
DP  - 2023 Feb 3
TI  - 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.
PG  - e41532
LID - 10.2196/41532 [doi]
LID - e41532
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.
CI  - (c)Christiaan Vis, Josien Schuurmans, Bruno Aouizerate, Mette Atipei Craggs, Philip 
      Batterham, Leah Buhrmann, Alison Calear, Arlinda Cerga Pashoja, Helen 
      Christensen, Els Dozeman, Claus Duedal Pedersen, David Daniel Ebert, Anne 
      Etzelmueller, Naim Fanaj, Tracy L Finch, Denise Hanssen, Ulrich Hegerl, Adriaan 
      Hoogendoorn, Kim Mathiasen, Carl May, Andia Meksi, Sevim Mustafa, Bridianne 
      O'Dea, Caroline Oehler, Jordi Piera-Jimenez, Sebastian Potthoff, Gentiana 
      Qirjako, Tim Rapley, Judith Rosmalen, Ylenia Sacco, Ludovic Samalin, Mette Maria 
      Skjoth, Kristine Tarp, Ingrid Titzler, Erik Van der Eycken, Claire Rosalie van 
      Genugten, Alexis Whitton, Enrico Zanalda, Jan H Smit, Heleen Riper. Originally 
      published in the Journal of Medical Internet Research (https://www.jmir.org), 
      03.02.2023.
FAU - Vis, Christiaan
AU  - Vis C
AUID- ORCID: 0000-0001-8783-8487
AD  - Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement 
      Sciences, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
AD  - Amsterdam Public Health research institute, Amsterdam, Netherlands.
AD  - Section for Research-based Innovation, Division of Psychiatry, Haukeland 
      University Hospital, Bergen, Norway.
FAU - Schuurmans, Josien
AU  - Schuurmans J
AUID- ORCID: 0000-0003-4029-1810
AD  - GGZ InGeest, Amsterdam, Netherlands.
FAU - Aouizerate, Bruno
AU  - Aouizerate B
AUID- ORCID: 0000-0002-7092-7747
AD  - Regional Reference Center for the Management and Treatment of Anxiety and 
      Depressive Disorders, FondaMental Advanced Centre of Expertise in Resistant 
      Depression, Deparment of General and Academic Psychiatry, Charles Perrens 
      Hospital, Bordeaux, France.
FAU - Atipei Craggs, Mette
AU  - Atipei Craggs M
AUID- ORCID: 0000-0001-8102-4597
AD  - Research Unit for Digital Psychiatry, Deptartment of Clinical Research, 
      University of Southern Denmark, Odense, Denmark.
FAU - Batterham, Philip
AU  - Batterham P
AUID- ORCID: 0000-0002-4547-6876
AD  - Centre for Mental Health Research, The Australian National University, Canberra, 
      Australia.
FAU - Buhrmann, Leah
AU  - Buhrmann L
AUID- ORCID: 0000-0001-6957-4369
AD  - Department of Social Work, Education and Community Wellbeing, Northumbria 
      University, Newcastle Upon Tyne, United Kingdom.
FAU - Calear, Alison
AU  - Calear A
AUID- ORCID: 0000-0002-7028-725X
AD  - Centre for Mental Health Research, The Australian National University, Canberra, 
      Australia.
FAU - Cerga Pashoja, Arlinda
AU  - Cerga Pashoja A
AUID- ORCID: 0000-0002-7029-947X
AD  - London School of Hygiene and Tropical Medicine, London, United Kingdom.
FAU - Christensen, Helen
AU  - Christensen H
AUID- ORCID: 0000-0003-0435-2065
AD  - Department of Medicine, University of New South Wales, Sydney, Australia.
FAU - Dozeman, Els
AU  - Dozeman E
AUID- ORCID: 0000-0002-3550-4298
AD  - GGZ InGeest, Amsterdam, Netherlands.
FAU - Duedal Pedersen, Claus
AU  - Duedal Pedersen C
AUID- ORCID: 0000-0002-6637-0392
AD  - Sundhed.dk, Odense, Denmark.
FAU - Ebert, David Daniel
AU  - Ebert DD
AUID- ORCID: 0000-0001-6820-0146
AD  - Professorship Psychology & Digital Mental Health, Technical University of Munich, 
      Munich, Germany.
AD  - HelloBetter, GET.ON Institut fur Online Gesundheitstrainings GmbH, Berlin, 
      Germany.
FAU - Etzelmueller, Anne
AU  - Etzelmueller A
AUID- ORCID: 0000-0001-8833-6067
AD  - Professorship Psychology & Digital Mental Health, Technical University of Munich, 
      Munich, Germany.
AD  - HelloBetter, GET.ON Institut fur Online Gesundheitstrainings GmbH, Berlin, 
      Germany.
FAU - Fanaj, Naim
AU  - Fanaj N
AUID- ORCID: 0000-0001-7375-643X
AD  - Mental Health Center Prizren, Prizren, Kosovo.
FAU - Finch, Tracy L
AU  - Finch TL
AUID- ORCID: 0000-0001-8647-735X
AD  - Department of Nursing, Midwifery and Health, Northumbria University, Newcastle 
      Upon Tyne, United Kingdom.
FAU - Hanssen, Denise
AU  - Hanssen D
AUID- ORCID: 0000-0003-0119-9608
AD  - Department of Psychiatry, University Medical Center Groningen, University of 
      Groningen, Groningen, Netherlands.
FAU - Hegerl, Ulrich
AU  - Hegerl U
AUID- ORCID: 0000-0003-2031-0594
AD  - German Depression Foundation, Leipzig, Germany.
AD  - Department of Psychiatry, Psychosomatics, and Psychotherapy, Goethe Universitat, 
      Frankfurt am Main, Germany.
FAU - Hoogendoorn, Adriaan
AU  - Hoogendoorn A
AUID- ORCID: 0000-0003-4784-0712
AD  - Amsterdam Public Health research institute, Amsterdam, Netherlands.
AD  - GGZ InGeest, Amsterdam, Netherlands.
AD  - Psychiatry, Amsterdam University Medical Center - location VUmc, Amsterdam, 
      Netherlands.
FAU - Mathiasen, Kim
AU  - Mathiasen K
AUID- ORCID: 0000-0001-6067-8866
AD  - Research Unit for Digital Psychiatry, Deptartment of Clinical Research, 
      University of Southern Denmark, Odense, Denmark.
AD  - Centre for Digital Psychiatry, Mental Health Services of Southern Denmark, 
      Odense, Denmark.
FAU - May, Carl
AU  - May C
AUID- ORCID: 0000-0002-0451-2690
AD  - Faculty of Public Health and Policy, London School of Hygiene and Tropical 
      Medicine, London, United Kingdom.
FAU - Meksi, Andia
AU  - Meksi A
AUID- ORCID: 0000-0003-1769-1488
AD  - Institute of Public Health, Tirana, Albania.
FAU - Mustafa, Sevim
AU  - Mustafa S
AUID- ORCID: 0000-0003-1105-6475
AD  - Mental Health Center Prizren, Prizren, Kosovo.
FAU - O'Dea, Bridianne
AU  - O'Dea B
AUID- ORCID: 0000-0003-1731-210X
AD  - Black Dog Institute, University of New South Wales, Sydney, Australia.
FAU - Oehler, Caroline
AU  - Oehler C
AUID- ORCID: 0000-0001-8329-147X
AD  - German Depression Foundation, Leipzig, Germany.
FAU - Piera-Jimenez, Jordi
AU  - Piera-Jimenez J
AUID- ORCID: 0000-0001-6471-9979
AD  - Catalan Health Service, Barcelona, Spain.
AD  - Digitalization for the Sustainability of the Healthcare System DS3-IDIBELL, 
      L'Hospitalet de Llobregat, Barcelona, Spain.
AD  - Faculty of Informatics, Multimedia and Telecommunications, Universitat Oberta de 
      Catalunya, Barcelona, Spain.
FAU - Potthoff, Sebastian
AU  - Potthoff S
AUID- ORCID: 0000-0003-4580-8532
AD  - Department of Social Work, Education and Community Wellbeing, Northumbria 
      University, Newcastle Upon Tyne, United Kingdom.
FAU - Qirjako, Gentiana
AU  - Qirjako G
AUID- ORCID: 0000-0003-3179-9006
AD  - Department of Public Health, Faculty of Medicine, University of Medicine, Tirana, 
      Albania.
FAU - Rapley, Tim
AU  - Rapley T
AUID- ORCID: 0000-0003-4836-4279
AD  - Department of Social Work, Education and Community Wellbeing, Northumbria 
      University, Newcastle Upon Tyne, United Kingdom.
FAU - Rosmalen, Judith
AU  - Rosmalen J
AUID- ORCID: 0000-0002-6393-0032
AD  - Department of Psychiatry, University Medical Center Groningen, University of 
      Groningen, Groningen, Netherlands.
AD  - Department of Internal Medicine, University Medical Center Groningen, University 
      of Groningen, Groningen, Netherlands.
FAU - Sacco, Ylenia
AU  - Sacco Y
AUID- ORCID: 0000-0002-2312-5231
AD  - Department of Mental Health, Local Health Authority Torino 3, ASLTO3, Torino, 
      Italy.
FAU - Samalin, Ludovic
AU  - Samalin L
AUID- ORCID: 0000-0003-0740-4019
AD  - Department of psychiatry, Centre Hospitalier Universitaire de Clermont-Ferrand, 
      Expert center for bipolar disorder (Foundation FondaMental), University of 
      Clermont Auvergne, Clermont-Ferrand, France.
AD  - Centre national de la recherche scientifique, Clermont-Auvergne INP, Institut 
      Pascal (UMR 6602), Clermont-Ferrand, France.
FAU - Skjoth, Mette Maria
AU  - Skjoth MM
AUID- ORCID: 0000-0002-3528-4619
AD  - Department of Dermatology and Allergy Centre, Odense University Hospital, Odense, 
      Denmark.
FAU - Tarp, Kristine
AU  - Tarp K
AUID- ORCID: 0000-0003-0901-855X
AD  - Research Unit for Digital Psychiatry, Deptartment of Clinical Research, 
      University of Southern Denmark, Odense, Denmark.
AD  - Centre for Digital Psychiatry, Mental Health Services of Southern Denmark, 
      Odense, Denmark.
FAU - Titzler, Ingrid
AU  - Titzler I
AUID- ORCID: 0000-0002-8963-2324
AD  - Department of Clinical Psychology and Psychotherapy, 
      Friedrich-Alexander-Universitat Erlangen-Nurnberg, Erlangen, Germany.
FAU - Van der Eycken, Erik
AU  - Van der Eycken E
AUID- ORCID: 0000-0001-5807-3366
AD  - GAMIAN Europe, Brussels, Belgium.
FAU - van Genugten, Claire Rosalie
AU  - van Genugten CR
AUID- ORCID: 0000-0003-3209-4673
AD  - Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement 
      Sciences, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
AD  - Amsterdam Public Health research institute, Amsterdam, Netherlands.
FAU - Whitton, Alexis
AU  - Whitton A
AUID- ORCID: 0000-0002-7944-2172
AD  - Black Dog Institute, University of New South Wales, Sydney, Australia.
FAU - Zanalda, Enrico
AU  - Zanalda E
AUID- ORCID: 0000-0003-4449-8384
AD  - Department of Mental Health, Local Health Authority Torino 3, ASLTO3, Torino, 
      Italy.
FAU - Smit, Jan H
AU  - Smit JH
AUID- ORCID: 0000-0002-2062-8378
AD  - Amsterdam Public Health research institute, Amsterdam, Netherlands.
AD  - Psychiatry, Amsterdam University Medical Center - location VUmc, Amsterdam, 
      Netherlands.
FAU - Riper, Heleen
AU  - Riper H
AUID- ORCID: 0000-0002-8144-8901
AD  - Clinical, Neuro-, & Developmental Psychology, Faculty of Behavioural and Movement 
      Sciences, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
AD  - Amsterdam Public Health research institute, Amsterdam, Netherlands.
AD  - Psychiatry, Amsterdam University Medical Center - location VUmc, Amsterdam, 
      Netherlands.
LA  - eng
SI  - ClinicalTrials.gov/NCT03652883
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20230203
PL  - Canada
TA  - J Med Internet Res
JT  - Journal of medical Internet research
JID - 100959882
SB  - IM
MH  - Humans
MH  - Mental Health
MH  - *Mental Health Services
MH  - Internet
MH  - Surveys and Questionnaires
MH  - *Cognitive Behavioral Therapy/methods
MH  - Treatment Outcome
PMC - PMC9938445
OTO - NOTNLM
OT  - common mental health disorders
OT  - iCBT
OT  - implementation strategies
OT  - internet-based cognitive behavioral therapy
OT  - mobile phone
OT  - tailored implementation
COIS- 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 fur Online Gesundheitstrainings GmbH fur 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.
EDAT- 2023/02/04 06:00
MHDA- 2023/02/08 06:00
PMCR- 2023/02/03
CRDT- 2023/02/03 11:53
PHST- 2022/07/29 00:00 [received]
PHST- 2022/11/30 00:00 [accepted]
PHST- 2022/11/18 00:00 [revised]
PHST- 2023/02/03 11:53 [entrez]
PHST- 2023/02/04 06:00 [pubmed]
PHST- 2023/02/08 06:00 [medline]
PHST- 2023/02/03 00:00 [pmc-release]
AID - v25i1e41532 [pii]
AID - 10.2196/41532 [doi]
PST - epublish
SO  - J Med Internet Res. 2023 Feb 3;25:e41532. doi: 10.2196/41532.