Cited by 133Digital Mental Health InterventionsMental Health Treatment and AccessTelemedicine and Telehealth Implementation

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 access
Kleiboer, Annet, Smit, Jan, Bosmans, Judith, Ruwaard, Jeroen, Andersson, Gerhard, Topooco, Naira, Berger, Thomas, Krieger, Tobias +16 more·2016·Trials

Abstract

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.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1186/s13063-016-1511-1

Cites

51 of 51 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

2 of the 53 references couldn’t be matched to a known paper.

Research works printed but not linked: 1

  1. [49]Food Drug Administration (FDA) International conference on harmonization, good clinical practice: consolidated guidelines Fed Regist 1997 62 25692 709

Cited by

Sorted by citations

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
Venue
Trials
Published
2016-08-03
Volume
17
Issue
1
Pages
387-387
ISSN
1745-6215 (ISSN-L)
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
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
  • Social Sciences › Psychology › Social Psychology › 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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review