Blended Cognitive Behavioral Therapy Versus Standard CBT for Unipolar Depression: A Multicenter Randomized Controlled Trial

This study evaluates 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. 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). Patients in the bCBT group showed greater improvements in depressive symptoms (primary outcome: d = .62, p < .001), anxiety (d = .61, p < .001), quality of life (d = .42, p < .001), perceived self-efficacy (d = .41, p = .003), depression literacy (d = .66, p < .001) and overall disease severity outcomes (d = .45-.60, ps < .005) compared with patients in the CBT group. In 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.