Effectiveness of blended depression treatment for adults in specialised mental healthcare: study protocol for a randomised controlled trial

BACKGROUND: Internet-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/DESIGN: The 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. DISCUSSION: The 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 REGISTRATION: Netherlands Trial Register NTR4962. Registered 05-01-2015.