Study Protocol for a Randomized Controlled, Non-Inferiority Trial on Blended Depression Treatment in Europe
Depression is a prevalent mental disorder with substantial personal and economic impacts. The E-COMPARED project investigates the effectiveness of blended cognitive behavioral therapy (bCBT), which integrates online and face-to-face interventions, against traditional treatment methods in routine primary and specialized mental health care settings across Europe.
Methods/Design: The study employs a pragmatic, multinational, randomized controlled, non-inferiority trial design. Adults diagnosed with major depressive disorder (MDD) are recruited from primary care in Germany, Poland, Spain, Sweden, and the United Kingdom, and from specialized mental health care in France, The Netherlands, and Switzerland. Participants are randomized to receive either blended depression treatment or treatment-as-usual (TAU). The primary outcome is the improvement in symptoms of depression, measured by the Patient Health Questionnaire-9 (PHQ-9) at 3, 6, and 12 months post-baseline.
Discussion: The E-COMPARED project is among the first to examine the effectiveness of bCBT in routine clinical practice across diverse European healthcare systems. It aims to provide evidence-based recommendations for the implementation of Internet-based treatments in primary and specialized care, potentially improving access to effective depression treatment and reducing healthcare costs.
Trial Registration: The trial is registered in multiple countries, including France (NCT02542891), Germany (DRKS00006866), The Netherlands (NTR4962), Poland (NCT02389660), Spain (NCT02361684), Sweden (NCT02449447), Switzerland (NCT02410616), and the United Kingdom (ISRCTN12388725).
This study represents a significant step forward in understanding how blended depression treatment can be integrated into routine clinical practice, offering a promising alternative to traditional face-to-face psychotherapy by potentially reducing the number of required in-person sessions while maintaining or even enhancing treatment outcomes.