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PauseAndFlourishMenopause Wellness Reviews & Guidance

Clinical Trial Protocol

Comparing CBT-I and HRT for Perimenopausal Insomnia: A Study Protocol

This study protocol outlines a randomized controlled trial comparing the efficacy of cognitive behavioral therapy for insomnia (CBT-I) and hormone replacement therapy (HRT) in perimenopausal women experiencing vasomotor symptoms and insomnia. The research aims to provide evidence-based treatment decisions to improve sleep quality and overall quality of life during this transitional phase.

Citation

Pavicic E, Stute P, Rudzik F, Urech A, Lozza-Fiacco S. No more sleepless nights in perimenopause-an open-label, randomized, parallel-group, active controlled intervention study in perimenopausal women with vasomotor symptoms and insomnia to investigate the efficacy of hormone replacement therapy and cognitive behavioral therapy for the treatment of insomnia: study protocol. Trials. 2025 Dec 30;27(1):94. doi: 10.1186/s13063-025-09366-9. PMID: 41462320.

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