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Sleep your way to better mental health: new study targets postpartum depression during pregnancy

NCT ID NCT06379074

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether an online sleep improvement program for pregnant women can reduce stress and prevent postpartum depression and anxiety. Researchers will enroll 114 women early in pregnancy and track their sleep, stress hormones, and mood for months after birth. The program includes weekly videos and chats with a clinician, all done from home.

What this could mean

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

Active substance
online behavioral sleep improvement program
What this could lead to
If it works, this could offer a simple, scalable way to reduce the risk of postpartum depression and anxiety by improving sleep during pregnancy.
What could go wrong
This is a small, early-stage study (114 participants) testing a behavioral intervention, so results may not apply to everyone. The program is online and self-guided, which may limit engagement and effectiveness.

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 114 people

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

Started

May 2024

Expected to finish

Oct 2026

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: 1. age ≥ 18 yrs. old; 2. good knowledge of Italian language; 3. intention to continue pregnancy; 4. BMI ranging 18-30 (i.e., without underweight or obesity following international criteria; WHO, 2013); 5. ≤ 15th week of pregnancy at the time of recruitment. Exclusion Criteria: 1. severe diagnosis of relevant somatic disorder; 2. smoking; 3. alcohol intake; 4. assumption of illegal drugs;

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Department of Biomedical and Neuromotor Sciences, Physiology campus, University of Bologna, Bologna, Italy

    RECRUITING

    Bologna, Bologna, 40126, Italy

  • Department of Human Sciences, Guglielmo Marconi university

    RECRUITING

    Rome, Rome, 00193, Italy

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