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Targeting Insomnia to Prevent Depression in the Menopause Transition
Sponsor: SRI International
Summary
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?
Key Details
Gender
FEMALE
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
230
Start Date
2026-09
Completion Date
2031-02
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
digital cognitive behavioral therapy for insomnia
A digital CBT-I program that includes stimulus control, sleep restriction therapy, and cognitive therapy
Digital sleep hygiene education
A digital sleep hygiene education intervention that includes recommendations about environmental and behavioral factors that can support healthy sleep.