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 - Cognitive Therapy/economics
KW - Comparative Effectiveness Research
KW - Cost-Benefit Analysis
KW - Depressive Disorder, Major
KW - Depressive Disorder, Major/diagnosis
KW - Equivalence Trial
KW - Europe
KW - Health Care Costs
KW - Humans
KW - Internet
KW - Journal Article
KW - Multicenter Study
KW - Pragmatic Clinical Trial
KW - Primary Health Care
KW - Randomized Controlled Trial
KW - Remission Induction
KW - Research Design
KW - Research Support, Non-U.S. Gov't
KW - Surveys and Questionnaires
KW - Therapy, Computer-Assisted
KW - Therapy, Computer-Assisted/economics
KW - Time Factors
KW - Treatment Outcome
U2 - https://doi.org/10.1186/s13063-016-1511-1
DO - https://doi.org/10.1186/s13063-016-1511-1
M3 - Article
C2 - 27488181
SN - 1745-6215
VL - 17
SP - 1
EP - 10
JO - Trials
JF - Trials
IS - 1
M1 - 387
ER -