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

Abstract

BackgroundEffective, 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/designE-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).DiscussionThe 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 registrationFrance: 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1511-1) contains supplementary material, which is available to authorized users.

Predicting Therapy Success and Costs for Personalized Treatment Recommendations Using Baseline Characteristics: Data-Driven Analysis (Preprint)

“…The E-Compared project hypothesized non-inferiority between both treatment types (meaning that BT is not less effective) [14]. Improvement was defined as the difference of the start and end value of the cumulated PHQ9 values.…”

“…The data we utilized originate from the EU funded project E-Compared in which the clinical and cost-effectiveness of blended treatment (BT) for depression, where Internet and face-to-face treatments are combined in one integrated treatment protocol, is evaluated and compared to treatment as usual (TAU) in nine different countries [14]. Participants were 18 years or older, met criteria for a major depressive disorder, were not of high suicidal risk, were not being treated for depression, and had access to an Internet connection.…”

“…The data consist of information regarding depressive symptoms, medical costs, and other aspects on an individual level. Because these questionnaires are widely utilized and known, we refer for more information to [14][15][16][17][18]. The data in the E-Compared project were collected at multiple times during the trial; at baseline, three months, six months, and twelve months.…”

“…Besides the size of the dataset, the data are heterogeneous in different ways. For example, the data were collected from nine different European countries which each have their own country specific conditions [14]. This can result in country specific patterns in the data.…”

Computer and psychotherapy – do they fit?

“…Dabei werden typischerweise 15-bis 20-stündige Verhaltenstherapien (oder "Treatmentas-usual"[TAU]-Bedingungen) mit gemischten Therapien verglichen, in denen die Hälfte der Sitzungen alternierend als selbstständig zu bearbeitende Onlinesitzungen zu bewältigen sind (Romijn et al 2015;Kemmeren et al 2016). Manche dieser Studien (Kemmeren et al 2016) bilden einen Teil des Projektes "European Comparative Effectiveness research on blended Depression treatment versus treatment-as-usual" (E-COMPARED), einer 2014 ins Leben gerufenen europäischen Forschungsinitiative aus 8 Ländern, die gemischte Psychotherapie in der Regelversorgung untersuchen soll (Kleiboer et al 2016). Alle Studien verfolgen das Ziel, gleiche Behandlungsergebnisse trotz umfangreicher Reduktion des direkten therapeutischen Face-to-faceAnteils zu erzielen.…”