Sleep your way to better mental health: new study targets postpartum depression during pregnancy
NCT ID NCT06379074
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
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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
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About 114 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Department of Biomedical and Neuromotor Sciences, Physiology campus, University of Bologna, Bologna, Italy
RECRUITINGBologna, Bologna, 40126, Italy
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Department of Human Sciences, Guglielmo Marconi university
RECRUITINGRome, Rome, 00193, Italy
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