Blended Cognitive Behavioral Therapy versus Standard Cognitive Behavioral Therapy for Unipolar Depression: A Multicenter Randomized Controlled Trial.

INTRODUCTION

This study evaluated the effectiveness of blended cognitive behavioral therapy (bCBT) with a digital health application (elona therapy) compared to standard cognitive behavioral therapy (CBT) for unipolar depression in outpatient care.

METHODS

This multicenter, randomized, two-arm controlled trial recruited 283 adult patients with unipolar depression in Germany. Patients were randomized to receive either standard face-to-face CBT combined with the digital health application (bCBT group) or standard face-to-face CBT alone. Symptoms of depression and anxiety, along with other patient-related characteristics, were assessed at baseline (T0: week 0) and post-intervention (T1: week 12).

RESULTS

Patients in the bCBT group showed greater improvements in depressive symptoms (primary outcome: d = 0.62, p < 0.001), anxiety (d = 0.61, p < 0.001), quality of life (d = 0.42, p < 0.001), perceived self-efficacy (d = 0.41, p = 0.003), depression literacy (d = 0.66, p < 0.001) and overall disease severity outcomes (d = 0.45-0.60, ps < 0.005) compared with patients in the CBT group.

CONCLUSION

This study provides evidence supporting the effectiveness of bCBT in patients diagnosed with unipolar depressive disorder across a broad range of clinically relevant outcomes. The discussion addresses important limitations of this trial.