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

Annet Kleiboer, Jan Smit, Judith Bosmans, Jeroen Ruwaard, Gerhard Andersson, Naira Topooco, Thomas Berger, Tobias Krieger, Cristina Botella, Rosa Banos, Karine Chevreul, Ricardo Araya, Arlinda Cerga-Pashoja, Roman Cieslak, Anna Rogala, Christiaan Vis, Stasja Draisma, Anneke van Schaik, Lise Kemmeren, David Ebert & 4 others Matthias Berking, Burkhardt Funk, Pim Cuijpers, Heleen 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
Pages (from-to)387
JournalTrials
Volume17
Issue number1
DOIs
Publication statusPublished - 3 Aug 2016

Cite this

Kleiboer, Annet ; Smit, Jan ; Bosmans, Judith ; Ruwaard, Jeroen ; Andersson, Gerhard ; Topooco, Naira ; Berger, Thomas ; Krieger, Tobias ; Botella, Cristina ; Banos, Rosa ; Chevreul, Karine ; Araya, Ricardo ; Cerga-Pashoja, Arlinda ; Cieslak, Roman ; Rogala, Anna ; Vis, Christiaan ; Draisma, Stasja ; van Schaik, Anneke ; Kemmeren, Lise ; Ebert, David ; Berking, Matthias ; Funk, Burkhardt ; Cuijpers, Pim ; Riper, Heleen. / 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, No. 1. pp. 387.
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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/economics, Comparative Effectiveness Research, Cost-Benefit Analysis, Depressive Disorder, Major/diagnosis, Europe, Health Care Costs, Humans, Internet, Primary Health Care, Remission Induction, Research Design, Surveys and Questionnaires, Therapy, Computer-Assisted/economics, Time Factors, Treatment Outcome",
author = "Annet Kleiboer and Jan Smit and Judith Bosmans and Jeroen Ruwaard and Gerhard Andersson and Naira Topooco and Thomas Berger and Tobias Krieger and Cristina Botella and Rosa Banos and Karine Chevreul and Ricardo Araya and Arlinda Cerga-Pashoja and Roman Cieslak and Anna Rogala and Christiaan Vis and Stasja Draisma and {van Schaik}, Anneke and Lise Kemmeren and David Ebert and Matthias Berking and Burkhardt Funk and Pim Cuijpers and Heleen Riper",
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Kleiboer, A, 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, no. 1, pp. 387. 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, Annet; Smit, Jan; Bosmans, Judith; Ruwaard, Jeroen; Andersson, Gerhard; Topooco, Naira; Berger, Thomas; Krieger, Tobias; Botella, Cristina; Banos, Rosa; Chevreul, Karine; Araya, Ricardo; Cerga-Pashoja, Arlinda; Cieslak, Roman; Rogala, Anna; Vis, Christiaan; Draisma, Stasja; van Schaik, Anneke; Kemmeren, Lise; Ebert, David; Berking, Matthias; Funk, Burkhardt; Cuijpers, Pim; Riper, Heleen.

In: Trials, Vol. 17, No. 1, 03.08.2016, p. 387.

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, Annet

AU - Smit, Jan

AU - Bosmans, Judith

AU - Ruwaard, Jeroen

AU - Andersson, Gerhard

AU - Topooco, Naira

AU - Berger, Thomas

AU - Krieger, Tobias

AU - Botella, Cristina

AU - Banos, Rosa

AU - Chevreul, Karine

AU - Araya, Ricardo

AU - Cerga-Pashoja, Arlinda

AU - Cieslak, Roman

AU - Rogala, Anna

AU - Vis, Christiaan

AU - Draisma, Stasja

AU - van Schaik, Anneke

AU - Kemmeren, Lise

AU - Ebert, David

AU - Berking, Matthias

AU - Funk, Burkhardt

AU - Cuijpers, Pim

AU - Riper, Heleen

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/economics

KW - Comparative Effectiveness Research

KW - Cost-Benefit Analysis

KW - Depressive Disorder, Major/diagnosis

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/economics

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1186/s13063-016-1511-1

DO - 10.1186/s13063-016-1511-1

M3 - Article

VL - 17

SP - 387

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

ER -