Targeting Insomnia to Prevent Depression in the Menopause Transition (NCT07443644) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Targeting Insomnia to Prevent Depression in the Menopause Transition
230 participantsStarted 2026-09
Plain-language 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?
Who can participate
Age range
40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. At least 40 years old and in the perimenopause,
. Willingness to participate in a digital research protocol,
. Current moderate to severe insomnia symptoms that started or worsened in association with perimenopause,
. English fluency.
Exclusion criteria
. Current major depressive disorder
. Existing diagnosis of a sleep disorder other than insomnia
. Experiencing excessive daytime sleepiness
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Depressive symptom severity (PHQ-9 score)
Timeframe: Baseline and every 3 months post randomization for 2 years
2
Insomnia severity index (ISI)
Timeframe: Baseline and every 3 months post-randomization for 2 years