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Sleep app could stop postpartum depression before it starts

NCT ID NCT05596318

Prevention Sponsor: University of California, San Francisco 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 sleep program (CBT-I) can prevent depression in pregnant people with insomnia. 456 participants will either use the CBT-I app or receive standard sleep hygiene education. Researchers will track who develops depression through one year after birth.

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 (CBT-I) via the Sleepio app
What this could lead to
If it works, this could offer a simple, scalable way to prevent depression during and after pregnancy by treating insomnia early.
What could go wrong
This is a single trial with no phase designation, so results are preliminary. The intervention is digital and may not work for everyone, and participants with current major depression were excluded.

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

456 people

The number who actually took part.

Started

Nov 2022

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 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: * Pregnant 14-28 weeks gestation * 18 years or older * Daily access to a web-enabled computer, smart phone, or tablet * Current elevated insomnia symptom severity and insomnia disorder * English speaking Exclusion Criteria: * Current major depression * Taking or planning to take antidepressant medication (ADM) * Other diagnosed or suspected sleep disorder * Other psychiatric or medical issues (e.g., bipolar disorder, active suicidality, bed rest) * Night shift worker

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder insomnia perinatal asphyxia prevention target

As listed by the trial registrant

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

Depression Insomnia

Contacts and locations

Locations

  • University of California, San Francisco

    San Francisco, California, 94118, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.