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European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries
Open accessAbstract
BACKGROUND: Effective, accessible, and affordable depression treatment is of high importance considering the large personal and economic burden of depression. Internet-based treatment is considered a promising clinical and cost-effective alternative to current routine depression treatment strategies such as face-to-face psychotherapy. However, it is not clear whether research findings translate to routine clinical practice such as primary or specialized mental health care. The E-COMPARED project aims to gain knowledge on the clinical and cost-effectiveness of blended depression treatment compared to treatment-as-usual in routine care. METHODS/DESIGN: E-COMPARED will employ a pragmatic, multinational, randomized controlled, non-inferiority trial in eight European countries. Adults diagnosed with major depressive disorder (MDD) will be recruited in primary care (Germany, Poland, Spain, Sweden, and the United Kingdom) or specialized mental health care (France, The Netherlands, and Switzerland). Regular care for depression is compared to "blended" service delivery combining mobile and Internet technologies with face-to-face treatment in one treatment protocol. Participants will be followed up at 3, 6, and 12 months after baseline to determine clinical improvements in symptoms of depression (primary outcome: Patient Health Questionnaire-9), remission of depression, and cost-effectiveness. Main analyses will be conducted on the pooled data from the eight countries (n = 1200 in total, 150 participants in each country). DISCUSSION: The E-COMPARED project will provide mental health care stakeholders with evidence-based information and recommendations on the clinical and cost-effectiveness of blended depression treatment. TRIAL REGISTRATION: France: ClinicalTrials.gov NCT02542891 . Registered on 4 September 2015; Germany: German Clinical Trials Register DRKS00006866 . Registered on 2 December 2014; The Netherlands: Netherlands Trials Register NTR4962 . Registered on 5 January 2015; Poland: ClinicalTrials.Gov NCT02389660 . Registered on 18 February 2015; Spain: ClinicalTrials.gov NCT02361684 . Registered on 8 January 2015; Sweden: ClinicalTrials.gov NCT02449447 . Registered on 30 March 2015; Switzerland: ClinicalTrials.gov NCT02410616 . Registered on 2 April 2015; United Kingdom: ISRCTN registry, ISRCTN12388725 . Registered on 20 March 2015.
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“Innovative healthcare delivery models, where self-management internet-delivered interventions are included, may prove crucial in overcoming organizational and financial barriers frequently associated to the traditional healthcare delivery model in the future, especially in countries where non-pharmacologic support is virtually absent in primary care, as is the case of Portugal (Kleiboer et al., 20”
From A guided internet-delivered individually-tailored ACT-influenced cognitive behavioural intervention to improve psychosocial outcomes in breast cancer survivors (iNNOVBC): Study protocol (2019) · cites this paper as Kleiboer et al., 2016
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“Blended psychotherapy, i.e., the combination of online intervention elements with standard psychotherapeutic care, is a rather new field of research (19–22).”
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“In feasibility and evaluation studies on iCBT in mental healthcare, the System Usability Scale (SUS) has increasingly been applied to measure usability [7–9]”
From Dimensionality of the system usability scale among professionals using internet-based interventions for depression: a confirmatory factor analysis (2020) · cites this paper as [9]
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“With regard to format, we have over the years done trials on smartphone-administration (Ly et al., 2014) and blended treatments (Ly et al., 2015b), and also been involved in EU-projects in this field (Kleiboer et al., 2016).”
MethodSelf-citation
Metadata
- Authors
- Kleiboer, A., Smit, J., Bosmans, J., Ruwaard, J., Andersson, G., Topooco, N., Berger, T., Krieger, T., Botella, C., Baños, R., Chevreul, K., Araya, R., Cerga-Pashoja, A., Cieślak, R., Rogala, A., Vis, C., Draisma, S., van Schaik, A., Kemmeren, L., Ebert, D., Berking, M., Funk, B., Cuijpers, P., & Riper, H.
- Affiliations
- Amsterdam Public Health (NL)
- Linköping University (SE)
- University of Bern (CH)
- Universitat Jaume I (ES)
- Assistance Publique – Hôpitaux de Paris (FR)
- London School of Hygiene & Tropical Medicine (GB)
- Uniwersytet SWPS (PL)
- Philipps University of Marburg (DE)
- Leuphana University of Lüneburg (DE)
- Corresponding author
- Kleiboer, Annet
- ORCID
- Kleiboer, Annet
- Bosmans, Judith
- Ruwaard, Jeroen
- Andersson, Gerhard
- Topooco, Naira
- Berger, Thomas
- Krieger, Tobias
- Botella, Cristina
- Baños, Rosa
- Chevreul, Karine
- Araya, Ricardo
- Cieślak, Roman
- Rogala, Anna
- Vis, Christiaan
- Draisma, Stasja
- Kemmeren, Lise
- Ebert, David
- Berking, Matthias
- Funk, Burkhardt
- Cuijpers, Pim
- Riper, Heleen
- Venue
- Trials
- Published
- 2016-08-03
- Volume
- 17
- Issue
- 1
- Pages
- 387-387
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC4972947
- OpenAlex
- W2500628273
- Cited by
- 133
- References
- 53
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 5 · 2023: 4 · 2022: 13 · 2021: 18 · 2020: 25 · 2019: 17 · 2018: 20 · 2017: 20 · 2016: 3
- FWCI
- 30.73
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- Multilingual Matters (Channel View Publications) (publishedVersion, cc-by)
- VU Research Portal (publishedVersion, other-oa)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Repositori UJI (Universitat Jaume I) (submittedVersion, other-oa)
- DiVA (Linkoping University) (submittedVersion, other-oa)
- Bern Open Repository and Information System (University of Bern) (submittedVersion, cc-by)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by-sa)
- Research Portal (King's College London) (submittedVersion, cc-by)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Funders
- Seventh Framework Programme (603098)
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Medicine › Psychiatry and Mental health › Mental Health Treatment and Access
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Keywords
- major depressive disorder, online therapy, mobile health, face-to-face psychotherapy, usual care, primary care, specialized mental health care, cost-effectiveness, non-inferiority, depression remission, PHQ-9, pragmatic trials, digital mental health interventions
- MeSH terms
- Equivalence Trials as Topic, Clinical Protocols, Cost-Benefit Analysis, Major Depressive Disorder, Europe, Humans, Primary Health Care, Surveys and Questionnaires, Remission Induction, Research Design, Therapy, Computer-Assisted, Time Factors, Cognitive Behavioral Therapy, Treatment Outcome, Health Care Costs, Internet, Comparative Effectiveness Research
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