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

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.