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

A.M. Kleiboer, J Smit, J. Bosmans, J. Ruwaard, G. Andersson, N. Topooco, T. Berger, T. Krieger, C. Botella, R. Banos, K. Chevreul, R. Araya, A. Cerga-Pashoja, R. Cieslak, A. Rogala, C. Vis, S. Draisma, A. Van Schaik, L. Kemmeren, D. Ebert & 4 others M. Berking, B. Funk, P. Cuijpers, H. Riper

Research output: Contribution to JournalArticleAcademicpeer-review

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.

Original languageEnglish
Article number387
Pages (from-to)1-10
Number of pages10
JournalTrials
Volume17
DOIs
Publication statusPublished - 3 Aug 2016

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Depression
Research
Netherlands
Cost-Benefit Analysis
Mental Health
Poland
Delivery of Health Care
Switzerland
Sweden
Internet
Spain
Therapeutics
France
Germany
Economic Recession
Major Depressive Disorder
Clinical Protocols
Non-Randomized Controlled Trials
Psychotherapy
Registries

Keywords

  • Clinical Protocols
  • Cognitive Therapy
  • Comparative Effectiveness Research
  • Cost-Benefit Analysis
  • Depressive Disorder, Major
  • Europe
  • Health Care Costs
  • Humans
  • Internet
  • Primary Health Care
  • Remission Induction
  • Research Design
  • Surveys and Questionnaires
  • Therapy, Computer-Assisted
  • Time Factors
  • Treatment Outcome
  • Equivalence Trial
  • Journal Article
  • Multicenter Study
  • Pragmatic Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

Cite this

Kleiboer, A.M. ; Smit, J ; Bosmans, J. ; Ruwaard, J. ; Andersson, G. ; Topooco, N. ; Berger, T. ; Krieger, T. ; Botella, C. ; Banos, R. ; Chevreul, K. ; Araya, R. ; Cerga-Pashoja, A. ; Cieslak, R. ; Rogala, A. ; Vis, C. ; Draisma, S. ; Van Schaik, A. ; Kemmeren, L. ; Ebert, D. ; Berking, M. ; Funk, B. ; Cuijpers, P. ; Riper, H. / 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. In: Trials. 2016 ; Vol. 17. pp. 1-10.
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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.",
keywords = "Clinical Protocols, Cognitive Therapy, Comparative Effectiveness Research, Cost-Benefit Analysis, Depressive Disorder, Major, Europe, Health Care Costs, Humans, Internet, Primary Health Care, Remission Induction, Research Design, Surveys and Questionnaires, Therapy, Computer-Assisted, Time Factors, Treatment Outcome, Equivalence Trial, Journal Article, Multicenter Study, Pragmatic Clinical Trial, Randomized Controlled Trial, Research Support, Non-U.S. Gov't",
author = "A.M. Kleiboer and J Smit and J. Bosmans and J. Ruwaard and G. Andersson and N. Topooco and T. Berger and T. Krieger and C. Botella and R. Banos and K. Chevreul and R. Araya and A. Cerga-Pashoja and R. Cieslak and A. Rogala and C. Vis and S. Draisma and {Van Schaik}, A. and L. Kemmeren and D. Ebert and M. Berking and B. Funk and P. Cuijpers and H. Riper",
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Kleiboer, AM, Smit, J, Bosmans, J, Ruwaard, J, Andersson, G, Topooco, N, Berger, T, Krieger, T, Botella, C, Banos, R, Chevreul, K, Araya, R, Cerga-Pashoja, A, Cieslak, R, Rogala, A, Vis, C, Draisma, S, Van Schaik, A, Kemmeren, L, Ebert, D, Berking, M, Funk, B, Cuijpers, P & Riper, H 2016, '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' Trials, vol. 17, 387, pp. 1-10. https://doi.org/10.1186/s13063-016-1511-1

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. / Kleiboer, A.M.; Smit, J; Bosmans, J.; Ruwaard, J.; Andersson, G.; Topooco, N.; Berger, T.; Krieger, T.; Botella, C.; Banos, R.; Chevreul, K.; Araya, R.; Cerga-Pashoja, A.; Cieslak, R.; Rogala, A.; Vis, C.; Draisma, S.; Van Schaik, A.; Kemmeren, L.; Ebert, D.; Berking, M.; Funk, B.; Cuijpers, P.; Riper, H.

In: Trials, Vol. 17, 387, 03.08.2016, p. 1-10.

Research output: Contribution to JournalArticleAcademicpeer-review

TY - JOUR

T1 - European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED)

T2 - study protocol for a randomized controlled, non-inferiority trial in eight European countries

AU - Kleiboer, A.M.

AU - Smit, J

AU - Bosmans, J.

AU - Ruwaard, J.

AU - Andersson, G.

AU - Topooco, N.

AU - Berger, T.

AU - Krieger, T.

AU - Botella, C.

AU - Banos, R.

AU - Chevreul, K.

AU - Araya, R.

AU - Cerga-Pashoja, A.

AU - Cieslak, R.

AU - Rogala, A.

AU - Vis, C.

AU - Draisma, S.

AU - Van Schaik, A.

AU - Kemmeren, L.

AU - Ebert, D.

AU - Berking, M.

AU - Funk, B.

AU - Cuijpers, P.

AU - Riper, H.

PY - 2016/8/3

Y1 - 2016/8/3

N2 - 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.

AB - 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.

KW - Clinical Protocols

KW - Cognitive Therapy

KW - Comparative Effectiveness Research

KW - Cost-Benefit Analysis

KW - Depressive Disorder, Major

KW - Europe

KW - Health Care Costs

KW - Humans

KW - Internet

KW - Primary Health Care

KW - Remission Induction

KW - Research Design

KW - Surveys and Questionnaires

KW - Therapy, Computer-Assisted

KW - Time Factors

KW - Treatment Outcome

KW - Equivalence Trial

KW - Journal Article

KW - Multicenter Study

KW - Pragmatic Clinical Trial

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1186/s13063-016-1511-1

DO - 10.1186/s13063-016-1511-1

M3 - Article

VL - 17

SP - 1

EP - 10

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 387

ER -