Efficacy and safety of a mobile app-based, flexible-schedule digital therapeutic intervention versus psychoeducation for panic disorder: An open-label randomized controlled trial

초록

Background: Digital therapeutics (DTx) have the potential to improve the accessibility and personalization of cognitive behavioral therapy (CBT) for panic disorder. However, trials comparing DTx with structured active comparators remain limited. Objective: We evaluated the efficacy and safety of PanicDoc, a mobile app-based DTx for panic disorder, versus structured psychoeducation. Methods: In this open-label randomized trial, 52 patients with panic disorder were randomly assigned to PanicDoc or psychoeducation, both delivered with therapist guidance (n = 26 per group). PanicDoc provided CBT-based modules with algorithm-based personalization over an 8- to 12-week treatment period, whereas the control group received biweekly structured psychoeducation over 12 weeks. The primary outcome was change from baseline in clinician-rated panic severity, assessed using the Panic Disorder Severity Scale (PDSS). Results: The PanicDoc group showed significantly greater improvement in PDSS in the end-of-intervention mixedeffects model for repeated measures (least squares mean difference = -3.71, P = .02). Post-treatment Clinical Global Impression-Improvement also favored PanicDoc over controls (t(39)= - 2.78, P = .008). Among participants allocated to PanicDoc, 21 of 26 (80.8%) completed the program; mean app usage was 47.9 (+/- 39.8) minutes/week. No significant between-group differences were observed on self-reported outcomes, although both groups showed within-group improvements on several secondary measures over time. No serious adverse events were reported. Conclusions: Guided DTx for panic disorder was associated with greater improvement in clinician-rated panic severity than an active psychoeducation control. However, superiority was not observed on self-reported outcomes, and the open-label design with unblinded clinician ratings warrants cautious interpretation. Trial Registration: KCT0009912 (https://cris.nih.go.kr/).

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