Clinician guidance in digital therapeutics for panic disorder: Meta-analytic dissection and implications for regulatory framing and scalable deployment

Abstract

Background: Digital therapeutics (DTx) have emerged as scalable and accessible treatment modalities for panic disorder. Objective: This study aimed to identify the extent to which clinician guidance impacts the digital intervention effectiveness for panic disorder across multiple clinical outcomes. Methods: This study included 40 randomized controlled trials of digital intervention for panic disorder published up to March 2025. Eligible studies enrolled adults with a primary diagnosis of panic disorder (with or without agoraphobia) and compared a digital therapeutic intervention against active (therapist-led or treatment-as-usual) or passive (waitlist or no-treatment) controls. Outcomes were the Panic Disorder Severity Scale (PDSS), Agoraphobic Cognitions Questionnaire (ACQ), and Body Sensations Questionnaire (BSQ). Random-effects meta-analyses, subgroup analyses, sensitivity analyses, and mixed-effects meta regressions were conducted. The moderator variables included the comparator type, guidance format (clinician-guidance or self-guided), intervention modality, and region. Results: Self-guided DTx demonstrated a moderate effect size on PDSS (Hedges' g =0.31, 95 % confidence interval [CI]: 0.05-0.68), whereas clinician-guided interventions exhibited stronger effects (g =0.95, 95 % CI: 0.44-1.46). These findings indicate that well-structured self-guided interventions can address symptom domains, involving panic frequency and physiological distress. Conversely, cognitive-focused outcome assessment using ACQ and BSQ revealed that only clinician-guided interventions yielded statistically significant and clinically meaningful improvements (ACQ: g =0.46, 95 % CI: 0.15-0.76; BSQ: g =0.67, 95 % CI: 0.30-1.05), whereas self-guided formats exhibited negligible effects (ACQ: g =0.11; BSQ: g =0.27). Conclusions: This meta-analysis revealed that self-guided digital interventions effectively reduce the overall symptom severity in panic disorder, whereas clinician involvement exerts a notably stronger influence on cognition-related outcomes. These findings support a domain-specific and context-sensitive understanding of guidance. Accordingly, the DTx design and policy should match the mechanistic pathways through which psychological change will occur.