Status: Not yet recruiting
Targeting Insomnia to Prevent Depression in the Menopause Transition
This randomized clinical trial is focused on perimenopausal women who have difficulty sleeping. It will randomize digital cognitive behavioral therapy for insomnia (dCBT-I) or a sleep hygiene intervention (SHI). After treatment, participants will be assessed every 3-months over a 2-year period. The two main questions the study aims to answer are: 1. Do participants receiving dCBT-I experience less severe depressive symptoms compared with sleep hygiene (SH) over 2 years of study participation? 2. Are the effects of dCBT-I on depressive symptom severity mediated by an improvement in insomnia symptoms?
Participants needed: 230
Trial details
Age: 40+Biological sex: FemaleType: InterventionalSponsor: SRI InternationalUpdated: Mar 2, 2026
Eligibility criteria
At least 40 years old and in the perimenopause, [+3]
Current major depressive disorder [+6]