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New study tests ROSE program to stop postpartum depression before it starts

NCT ID NCT04940585

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a program called ROSE, which includes six group sessions and one individual session for pregnant women. The goal is to see if it can prevent postpartum depression, reduce stress, and increase social support. About 308 pregnant women receiving care at a specific clinic will take part. The program covers topics like adjusting to life with a baby, effective communication, and planning for the future.

What this could mean

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

Active substance
ROSE program (a series of 6 group sessions plus an individual session focused on psychoeducation, communication, and planning)
What this could lead to
If it works, this could provide an effective, scalable way to prevent postpartum depression in at-risk pregnant women.
What could go wrong
This is a relatively small, single-site study testing a behavioral intervention, so results may not apply broadly. The program may not significantly reduce depression compared to usual care.

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 308 people

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

Started

Mar 2021

Expected to finish

Dec 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 to 100 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Receive prenatal care at the Sunset Park Family Health Center for Women's Health and Pediatrics (SPWHP) * Female * At least 18 years of age * Speaks and understands English or Spanish (depending on the language of the next group) * Is pregnant * Is in the second trimester of her pregnancy * Capable of providing informed consent. * Scores between 4 and 12 on Edinburgh Postnatal Depression Scale or records 2 or more ACEs on adapted ACEs questionnaire Exclusion Criteria: * Not receiving prenatal care at the Sunset Park Family Health Center for Women's Health and Pediatrics (SPWHP) * Not female * Under18 years of age * Does not speak and understand English or Spanish * Is not pregnant * Is not in the second trimester of her pregnancy * Is not capable of providing informed consent. * Scoring \< 4or \>12 on Edinburgh Postnatal Depression Scale and scores 1 or less on adapted ACEs questionnaire. * Positive score to #10 on the Edinburgh Postnatal Depression Scale

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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

    1 site. 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

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

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