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Can bright light and better sleep beat baby blues? new trial tests Drug-Free fix for perinatal depression

NCT ID NCT04364646

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a non-drug treatment called Personalized Integrated Chronotherapy (PIC) for depression during pregnancy and after childbirth. 120 pregnant women with major depression were randomly assigned to receive either usual care (medication or therapy) or PIC plus usual care. PIC combines morning bright light therapy with personalized sleep scheduling to reset the body's internal clock. The goal was to see if this approach could reduce depressive symptoms more than standard care alone.

What this could mean

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

Active substance
Personalized Integrated Chronotherapy (bright light therapy, sleep schedule adjustments)
What this could lead to
If it works, this could offer a safe, non-drug option to treat depression during and after pregnancy, improving outcomes for mothers and babies.
What could go wrong
This is a relatively small, early-stage trial (120 participants) and the therapy requires strict adherence to sleep schedules, which may be hard for new mothers. Results may not apply to all.

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

120 people

The number who actually took part.

Started

Nov 2020

Finished

Jun 2025

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 to 45 years

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 women, ages 18-45 years with a HAMD score \>=14 and a current DSM-5 diagnosis of major depressive disorder as determined with the Current Major Depression Module of the Structured Clinical Interview for DSM disorders (SCID-I/P) Exclusion Criteria: * active psychosis or suicidality contraindicating outpatient treatment as determined by the clinical judgement of the research team and as measured with the B/C module of the SCID-I/P and the Columbia-Suicide Severity Rating Scale * bipolar disorder (because sleep restriction can increase risk of conversion to mania) * seizure disorder (because sleep restriction can increase seizure risk) * self report of frequent migraines/headaches precipitated by bright light or sleep deprivation * preexisting eye/skin disorders contraindicating light therapy * use of photosensitizing medications * primary Axis I diagnosis other than MDD (e.g., anorexia nervosa, ADHD) * high risk pregnancy (e.g., conditions requiring mandatory bed rest or complex medical regimens that will interfere with study participation or conditions where poor infant outcomes are anticipated) * starting antidepressants in the 4 weeks prior to enrollment * current employment as night shift worker * Alcohol Use Disorders Identification Test (AUDIT) score \> 8 and/or Drug Abuse Screening Test (DAST) \> 1 indicating current alcohol or drug use disorders * women whose infants will not be living in the home or who will have a nighttime caregiver * Pittsburgh Sleep Quality Inventory (PSQI)190 \< 5 (i.e., those who report no sleep complaints during 3rd trimester of pregnancy and for whom an intervention targeting sleep might not be indicated). * women who do not speak and read English because PIC research instruments are only available in English at this time. If this RCT shows effectiveness, future work will examine effectiveness in women who speak and read languages other than English. * Women who experience fetal loss or stillbirth, as well as mothers whose infants are born before 36 weeks' gestation or have NICU stays \> 5 days, will be discontinued from the study but will continue to receive UC.

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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.

Contacts and locations

Locations

  • Feinstein Institute For Medical Research

    Glen Oaks, New York, 11004, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

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