Efficacy of a Prescription-Based Mobile Digital Therapeutic as an Adjunct to Pharmacotherapy for the Acute Phase of Panic Disorder: Multicenter Randomized Controlled Trial.

Background: Although pharmacotherapy is the primary treatment for patients with acute-phase panic disorder, its incomplete efficacy causes them to experience frequent panic attacks and severe anticipatory anxiety for a considerable period. A prescription-based mobile digital therapeutic (DTx) that integrates self-guided cognitive behavioral therapy (CBT), real-time symptom management, and lifestyle tracking can be used as an adjunct to pharmacotherapy for these patients, helping them achieve rapid symptom recovery. Objective: This study aimed to evaluate the efficacy of this adjunctive DTx in alleviating symptoms in patients with acute-phase panic disorder. Methods: In total, 66 acute-phase patients experiencing frequent panic attacks were recruited from 6 institutions and randomly divided into a group receiving pharmacotherapy combined with DTx or pharmacotherapy alone, participating in an 8-week multicenter single-blind trial. The DTx app included 3 major services: training service consisting of structured CBT modules, companion service of just-in-time modules for coping with panic attacks, and care service providing daily self-management tracking tools. The self-report scales used as efficacy indicators were administered via paper questionnaires during a total of 4 visits at baseline, week 2, week 4, and week 8. The primary end point, the change in the Panic Disorder Severity Scale-Self Report (PDSS-SR) score, and the secondary end points, such as changes in overall anxiety, depression, panic-related catastrophic cognitions, and fear of bodily sensations, were compared between the 2 groups. Adherence to the DTx was objectively assessed using device use metrics. Results: As 5 enrolled patients were excluded due to insufficient safety analysis or efficacy evaluation, the final analysis included 32 in the DTx group and 29 in the control group. The DTx group showed a significantly greater reduction in PDSS-SR scores at week 8 compared to the control group (mean 40.29%, SD 26.68% vs mean 17.61%, SD 30.37%; Conclusions: The adjunctive use of our prescription-based DTx resulted in early and sustained symptom reductions across panic severity, overall anxiety, and catastrophic cognitions, suggesting that this multifunctional and self-guided DTx including just-in-time management and lifestyle tracking can serve as a practical complement to routine psychiatric care for acute-phase patients experiencing frequent panic attacks. This app is expected to present a new framework for the treatment of acute-phase panic disorder by enabling the incorporation of various symptomatic aspects in patients' daily life into clinicians' evaluations and guidance in the clinic.