Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: May 12, 2026
Date Accepted: Sep 9, 2026
Efficacy of a Prescription-based Mobile Digital Therapeutic as an Adjunct to Pharmacotherapy for the Acute Phase of Panic Disorder: Multicenter Randomized Controlled Trial
ABSTRACT
Background:
Although pharmacotherapy is the primary treatment for patients with acute-phase panic disorder, its incomplete efficacy causes them to suffer from frequent panic attacks and severe anticipatory anxiety for a considerable period. A prescription-based mobile digital therapeutic (DTx) that integrate self-guided cognitive behavioral therapy, real-time symptom management, and lifestyle tracking, can be utilized as an adjunct to pharmacotherapy for these patients, helping them achieve rapid symptom recovery.
Objective:
The present study aimed to evaluate the efficacy of this adjunctive DTx in alleviating symptoms in patients with acute-phase panic disorder.
Methods:
Sixty-six patients with acute-phase panic disorder were recruited from six institutions and randomly divided into a group receiving pharmacotherapy combined with DTx or pharmacotherapy alone, participating in in an 8-week multicenter single-blind trial. The primary endpoint, the change in the Panic Disorder Severity Scale-Self Report (PDSS-SR) score, and the secondary endpoints, such as changes in overall anxiety, depression, panic-related catastrophic cognitions, and fear of bodily sensations, were compared between the two groups.
Results:
The DTx group of 32 patients showed a significantly greater reduction in PDSS-SR scores at Week 8 compared to the control group of 29 patients (40.29% vs. 17.61%; P=.007). This therapeutic benefit appeared rapidly by Week 2 (26.66% vs. 11.05%; P=.016). The responder (≥40% PDSS-SR reduction) rate was also significantly higher in the DTx group (53.12% vs. 17.24%; P=.007). While changes in depression and somatic fears were transient or similar between groups, the DTx group showed significantly greater sustained improvements in overall anxiety and catastrophic cognitions.
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 patients with acute-phase panic disorder. Clinical Trial: Clinical Research Information Service (KCT0010500; https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&focus=reset_12&search_page=L&pageSize=10&page=undefined&seq=34277&status=5&seq_group=29599
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