In a pilot randomized controlled trial, the safety and effectiveness of a novel blended cognitive behavioral therapy (bCBT) application, integrating in-person therapy with digital components like health apps, were evaluated for treating unipolar depression in adults. The study compared this approach with conventional CBT administered alone in standard care.

A total of 82 volunteers were randomized into 2 groups: bCBT (42 participants) and CBT (40 participants) for a 12-week period. The bCBT group participated in weekly CBT sessions, augmented by the elona therapy depression module—an application designed for bCBT in treating unipolar depression—used between sessions. The standard CBT group participated in weekly CBT sessions. Outcome analyses at 6 and 12 weeks were carried out utilizing linear mixed models.

Although improvements in depressive symptoms (Beck Depression Inventory-II [BDI-II], Patient Health Questionnaire-9 [PHQ-9]) were notably more pronounced in the bCBT group, this disparity did not achieve clinical meaningfulness. bCBT demonstrated superiority over standard CBT in secondary outcome measures related to generalized anxiety symptoms (d = -.45) and psychological health (d = .50).

In various other secondary endpoints (World Health Organization Quality of Life [WHOQOL-BREF], General Self-Efficacy Scale [GSE], Penn State Worry Questionnaire [PSWQ], Beck Anxiety Inventory [BAI]), betterments were also observed to be descriptively more substantial in the bCBT group in comparison with the CBT.

bCBT might be advantageous compared to CBT alone in the management of depression. Larger RCTs of the bCBT application are required for a more comprehensive evaluation.