A 12-week, fully decentralized, open-label pilot RCT evaluated a self-guided digital CBT app added to usual care vs. usual care alone in 100 menopausal women with bothersome vasomotor symptoms (VSS), measuring hot flush problem rating as the primary outcome.
Digital CBT produced a between-group difference of -1.47 points in hot flush problem rating (95% CI -2.29 to -0.65; p < 0.001; SMD 0.74); 70.8% of intervention vs. 29.5% of control participants achieved a ≥2-point (clinically meaningful) reduction. No serious adverse events occurred; 5.9% reported minor device-related events.
Open-label design precludes blinding; per-protocol analysis covered only 28 of 51 intervention participants, suggesting moderate app engagement; all outcomes were self-reported.
A self-guided digital CBT app may offer a safe, non-pharmacological option for menopausal women troubled by hot flushes — especially those who cannot or prefer not to use hormone therapy. Clinicians should set realistic expectations around patient engagement, as only about half of app users completed the protocol.
