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Sleep therapy may stop menopause depression before it starts

NCT ID NCT07443644

Prevention Sponsor: SRI International Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a digital insomnia treatment (dCBT-I) can prevent depression in perimenopausal women with sleep problems. 230 women will receive either dCBT-I or sleep hygiene education and be followed for 2 years. The goal is to see if improving sleep reduces depressive symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
digital cognitive behavioral therapy for insomnia (dCBT-I)
What this could lead to
If it works, this could offer a non-drug way to prevent depression during menopause by treating insomnia early.
What could go wrong
This trial hasn't started yet, so results are uncertain. The intervention is behavioral, not a drug, and may not work for everyone. Also, it excludes women with current major depression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. At least 40 years old and in the perimenopause, 2. Willingness to participate in a digital research protocol, 3. Current moderate to severe insomnia symptoms that started or worsened in association with perimenopause, 4. English fluency. Exclusion Criteria: 1. Current major depressive disorder 2. Existing diagnosis of a sleep disorder other than insomnia 3. Experiencing excessive daytime sleepiness 4. Having received CBT-I in the preceding 6 months 5. Severe psychiatric or medical conditions or medications that could compromise safe participation in the study or interfere with the scientific aims 6. Hysterectomy and/or bilateral ovariectomy or current hormonal therapy, 7. Night shift worker

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Conditions

The condition(s) this trial relates to.

Hot Flashes insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia Menopause related conditions

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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