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Can doulas help new moms beat the baby blues?

NCT ID NCT07614789

Disease control Sponsor: Duke University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Updated 2 times

Summary

This study tests whether doulas can successfully deliver an 8-week program called YouMatter to new or expecting mothers at risk for postpartum depression. The program combines mental health support, parenting tips, and self-care. Forty mothers with mild depression symptoms will participate, and researchers will check how well doulas follow the program.

What this could mean

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

Active substance
YouMatter behavioral intervention
What this could lead to
If successful, this could show that doulas can effectively deliver mental health and parenting support, making such programs more accessible to new mothers.
What could go wrong
This is a very small pilot study (40 participants) focused on feasibility, not effectiveness. It may not prove the intervention works or can be scaled.

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 40 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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 are: 1. Edinburgh Postpartum Depression score of 10 or greater; 2. currently pregnant or within the first 3 years postpartum. Exclusion criteria includes: 1. high risk of an imminent suicide attempt; 2. actively psychotic or manic; 3. current drug or alcohol use disorder; 4. significant health complications (e.g., cancer).

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Conditions

The condition(s) this trial relates to.

postpartum depression puerperal disorder

As listed by the trial registrant

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

Maternal depression Maternal depression and parent practices, postpartum Post partum

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

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

More trials for these conditions

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