NCT07443644

Targeting Insomnia to Prevent Depression in the Menopause Transition

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: SRI International · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

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?

Detailed description

Insomnia is a common problem for women in perimenopause. Previous research found that insomnia predicts future development of depression and suggests that treating insomnia can lead to improvement in mood. This study will investigate the long-term effects of treating insomnia with two different interventions on depression among perimenopausal individuals. The two interventions are, digital cognitive behavioral therapy for insomnia (dCBT-I), which has been proven effective, and sleep hygiene intervetion (SHI), which is in common use in general practice. Participants will be screened for eligibility. Those eligible will be randomized to one of the two treatment arms (dCBT-I or SHI) and complete assessments at 3-month intervals across a 2-year period. Assessments will include questionnaires, clinical interviews, and using a wearable device. All assessments will be done remotely. Aim 1: To determine if dCBT-I in the menopause transition prospectively prevents depressive symptoms and improves menopause-specific quality of life. Aim 2: To determine whether the effect of dCBT-I on depressive symptoms is mediated through improving insomnia symptom severity (primary) and secondarily, reducing wakefulness after sleep onset in the menopause transition. The study will also explore pathways linking dCBT-I and prevention of depressive symptoms.

Conditions

• Insomnia
• Menopause Related Conditions

Interventions

Type	Name	Description
BEHAVIORAL	digital cognitive behavioral therapy for insomnia	A digital CBT-I program that includes stimulus control, sleep restriction therapy, and cognitive therapy
BEHAVIORAL	Digital sleep hygiene education	A digital sleep hygiene education intervention that includes recommendations about environmental and behavioral factors that can support healthy sleep.

Timeline

• Start date: 2026-09-01
• Primary completion: 2031-02-01
• Completion: 2031-02-01
• First posted: 2026-03-02
• Last updated: 2026-03-02