Enhancing the effectiveness of CBT for patients with unipolar depression by integrating digital interventions into treatment: A pilot randomized controlled trial

Objective Blended cognitive behavioral therapy (bCBT) combines face-to-face therapy with digital elements, such as digital health apps. This pilot study aimed to explore the effectiveness and safety of a novel bCBT application for treating unipolar depression in adults combined with cognitive behavioral therapy (CBT) compared to CBT alone in routine care. Methods Patients (N = 82) were randomly assigned to bCBT (n = 42) or CBT (n = 40) over 12 weeks. bCBT consisted of weekly CBT sessions accompanied by the elona therapy depression module (a bCBT application for unipolar depression) for use between sessions. Standard CBT consisted of weekly CBT sessions. Outcomes (6,12 weeks) were analyzed with linear mixed models. Results Improvements in depressive symptoms (BDI-II, PHQ-9) were descriptively larger for the bCBT group. Yet, this difference did not reach statistical significance. bCBT was superior to standard CBT in secondary outcome measures of psychological health (d = .50) and generalized anxiety symptoms (d = -.45). In other secondary outcomes (BAI, PSWQ, GSE, WHOQOL-BREF), improvements were descriptively larger for bCBT compared to CBT. Conclusion This pilot study provided preliminary evidence that bCBT might be advantageous in comparison to CBT alone in the treatment of depression, but larger RCTs of the bCBT application are needed.