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.

BackgroundLittle is known about potential harmful effects as a consequence of self-guided internet-based cognitive behaviour therapy (iCBT), such as symptom deterioration rates. Thus, safety concerns remain and hamper the implementation of self-guided iCBT into clinical practice. We aimed to conduct an individual participant data (IPD) meta-analysis to determine the prevalence of clinically significant deterioration (symptom worsening) in adults with depressive symptoms who received self-guided iCBT compared with control conditions. Several socio-demographic, clinical and study-level variables were tested as potential moderators of deterioration.MethodsRandomised controlled trials that reported results of self-guided iCBT compared with control conditions in adults with symptoms of depression were selected. Mixed effects models with participants nested within studies were used to examine possible clinically significant deterioration rates.ResultsThirteen out of 16 eligible trials were included in the present IPD meta-analysis. Of the 3805 participants analysed, 7.2% showed clinically significant deterioration (5.8% and 9.1% of participants in the intervention and control groups, respectively). Participants in self-guided iCBT were less likely to deteriorate (OR 0.62, p < 0.001) compared with control conditions. None of the examined participant- and study-level moderators were significantly associated with deterioration rates.ConclusionsSelf-guided iCBT has a lower rate of negative outcomes on symptoms than control conditions and could be a first step treatment approach for adult depression as well as an alternative to watchful waiting in general practice.

BackgroundInternet-based interventions are seen as an important potential strategy to improve accessibility and affordability of high quality treatments in mental healthcare. A growing number of studies have demonstrated the clinical efficacy of internet-based treatment for mood disorders, but scientific evidence for the application in routine specialised mental healthcare settings is limited. Also, little is known about the clinical and health-economic benefits of blended treatment, where online interventions are integrated with face-to-face treatment of depression in one treatment protocol. The primary aim of this study is to investigate the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (bCBT) for depression, as compared to treatment as usual (TAU) in specialised routine mental healthcare in the Netherlands. This trial is part of the E-COMPARED project which has a broader perspective, focussing on primary and specialised care in eight European countries.Methods/DesignThe study is a randomised controlled non-inferiority trial with two parallel conditions: bCBT and TAU. The blended treatment combines individual face-to-face CBT with CBT delivered through an Internet-based treatment platform (Moodbuster). This platform includes a mobile phone application, used for ecological momentary assessments, automated feedback and motivational messages. Weekly alternating face-to-face (10) and online (9) sessions will be delivered over a period of 19-20 weeks. TAU is defined as the routine care that subjects receive when they are diagnosed with depression in specialised mental healthcare. Adult patients ≥ 18 years old meeting DSM-IV diagnostic criteria for major depressive disorder will be recruited within participating outpatient specialised mental healthcare clinics in the Netherlands. Measurements will be taken at baseline and at 3, 6 and 12 months follow-up. The primary outcome will be depressive symptoms, measured with the PHQ-9 and QIDS. Secondary outcomes include health-related quality of life, mastery, treatment preference, working alliance, system usability, treatment satisfaction and possible negative side-effects. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective and will include both direct and indirect healthcare costs.DiscussionThe results of this study will provide insight into the health and economical outcomes of blended treatment for depression and give an indication of the value of implementing blended treatment in specialised clinical settings.Trial registrationNetherlands Trial Register NTR4962. Registered 05-01-2015.

Background Blended treatments, combining digital components with face-to-face (FTF) therapy, are starting to find their way into mental health care. Knowledge on how blended treatments should be set up is, however, still limited. To further explore and optimize blended treatment protocols, it is important to obtain a full picture of what actually happens during treatments when applied in routine mental health care. Objective The aims of this study were to gain insight into the usage of the different components of a blended cognitive behavioral therapy (bCBT) for depression and reflect on actual engagement as compared with intended application, compare bCBT usage between primary and specialized care, and explore different usage patterns. Methods Data used were collected from participants of the European Comparative Effectiveness Research on Internet-Based Depression Treatment project, a European multisite randomized controlled trial comparing bCBT with regular care for depression. Patients were recruited in primary and specialized routine mental health care settings between February 2015 and December 2017. Analyses were performed on the group of participants allocated to the bCBT condition who made use of the Moodbuster platform and for whom data from all blended components were available (n=200). Included patients were from Germany, Poland, the Netherlands, and France; 64.5% (129/200) were female and the average age was 42 years (range 18-74 years). Results Overall, there was a large variability in the usage of the blended treatment. A clear distinction between care settings was observed, with longer treatment duration and more FTF sessions in specialized care and a more active and intensive usage of the Web-based component by the patients in primary care. Of the patients who started the bCBT, 89.5% (179/200) also continued with this treatment format. Treatment preference, educational level, and the number of comorbid disorders were associated with bCBT engagement. Conclusions Blended treatments can be applied to a group of patients being treated for depression in routine mental health care. Rather than striving for an optimal blend, a more personalized blended care approach seems to be the most suitable. The next step is to gain more insight into the clinical and cost-effectiveness of blended treatments and to further facilitate uptake in routine mental health care.