Efficacy and safety of interactive digital therapeutics with cognitive behavioral therapy for depressive symptoms in patients with major depressive disorder: A multicenter, randomized, assessor-blinded trial versus an active mood diary control.

In 30 seconds

This multicenter, randomized, assessor-blinded 8-week trial compared interactive digital cognitive behavioral therapy (iDT-CBT) with an active mood diary in 110 adults with major depressive disorder. At Week 8, BDI-II scores improved more with iDT-CBT (13.34 vs. 6.54 points; adjusted p = 0.0003). Improvements in PHQ-9, MADRS, and BAI also favored iDT-CBT, and remission proportions were higher across all four measures. However, findings for BDI-II and PHQ-9 were not significant in several sensitivity analyses, whereas MADRS and BAI effects remained significant. No intervention-related serious adverse events occurred.

Key findings

• BDI-II improvement at Week 8 was 13.34 vs. 6.54 points with iDT-CBT and mood diary, respectively (adjusted p = 0.0003).
• Remission proportions favored iDT-CBT for BDI-II (30.4% vs. 9.3%), PHQ-9 (62.5% vs. 44.4%), MADRS (23.2% vs. 5.6%), and BAI (50.0% vs. 20.4%).
• In sensitivity analyses, BDI-II and PHQ-9 effects were not significant, while MADRS and BAI effects remained significant.
• There were no adverse-event-related discontinuations or intervention-related serious adverse events.

Why it matters

Interactive digital CBT may offer a short-term option for adults with major depressive disorder, with improvements across several symptom measures compared with an active mood diary control. The differing results across analytical methods, particularly for self-reported depressive symptoms, temper confidence in the size and robustness of benefit. The findings support further evaluation rather than establishing durable effectiveness.

What to keep in mind

Follow-up was limited to 8 weeks. BDI-II and PHQ-9 findings were sensitive to the analytical method, and longer-term studies are needed.