Lindus Health and Frieda Health have concluded a clinical trial assessing the Frieda Menova app, a digital therapeutic integrating cognitive behavioral therapy (CBT) aimed at alleviating menopausal symptoms. The open-label pilot study involved 100 participants with physician-confirmed natural menopause and clinically significant symptoms. Conducted remotely across Germany, the trial utilized telemedicine for screening and enrollment, enhancing accessibility.
The study demonstrated that the Frieda Menova app led to substantial reductions in vasomotor disturbances, sleep disruption, and psychological distress compared to standard care. This marks the first clinical trial evaluating a digital CBT approach for menopause symptom management. The results suggest that digital CBT could serve as a viable alternative for women seeking non-hormonal treatments.
Lindus Health provided comprehensive oversight of the trial, including regulatory submissions, participant recruitment, monitoring, data management, and statistical analysis. The company also deployed innovative recruitment strategies through targeted social media campaigns, facilitating efficient participant engagement.
The successful completion of this trial underscores the potential of digital therapeutics in addressing menopause-related health issues, offering a scalable and accessible treatment option for women worldwide.
