Effectiveness of a digital cognitive behavioral therapy application for vasomotor symptoms in menopausal women: An open-label pilot randomized controlled trial.

OBJECTIVES: To estimate the 12-week effect of an individual, self-guided digital cognitive behavioral therapy application added to usual care for bothersome menopausal vasomotor symptoms. STUDY DESIGN: Fully decentralized, open-label, parallel-group pilot randomized controlled trial. MAIN OUTCOME MEASURES: The primary outcome was change in hot flush problem rating from baseline to week 12. Secondary outcomes included hot flush frequency, menopausal symptom burden (Menopause Rating Scale II), insomnia severity (Insomnia Severity Index), and perceived stress. Clinically meaningful improvement was assessed using prespecified thresholds. RESULTS: One hundred participants were randomized (51 intervention, 49 control); 92 completed week 12. Adjusted mean change in the primary intention-to-treat analysis was -2.68 versus -1.21, a between-group difference of -1.47 points (95% confidence interval -2.29 to -0.65; p < 0.001; standardized mean difference 0.74). A reduction of at least two points occurred in 70.8% versus 29.5% of participants with responder data. Per-protocol analysis included 28 intervention participants. No serious adverse events occurred; 5.9% reported device-related events. CONCLUSIONS: In this open-label pilot trial, digital cognitive behavioral therapy produced clinically meaningful improvements in bothersome vasomotor symptoms and related menopausal symptoms over 12 weeks compared with usual care, with excellent safety and tolerability. These findings support digital cognitive behavioral therapy as an effective non-pharmacological option for managing menopausal symptoms, though further confirmation is warranted given the moderate level of participant engagement and the use of self-reported outcomes. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00036152.