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Doula-Delivered therapy and heart health coaching aims to protect new moms

NCT ID NCT06666400

Disease control Sponsor: Columbia 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a program called Living Healthy for Moms, where doulas provide cognitive behavioral training and heart health coaching to new mothers. The goal is to reduce postpartum depression and lower the risk of heart problems. The trial includes 21 mothers who recently gave birth, focusing on those from minority or low-income backgrounds. The program starts in the hospital and continues for six months after birth.

What this could mean

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

Active substance
behavioral intervention (cognitive behavioral training plus cardiovascular health coaching delivered by doulas)
What this could lead to
If successful, this could provide a practical, community-based program to lower postpartum depression and heart disease risk in new mothers, especially those from minority or low-income backgrounds.
What could go wrong
This is a small early-stage trial with only 21 participants, so results may not apply to everyone. The program requires active participation and may not work for all mothers.

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

21 people

The number who actually took part.

Started

Jan 2025

Expected to finish

Jun 2030

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: * Birthing individuals aged 18 years or older * Delivery of singleton live birth; and * Minority race (self-identified Black), minority ethnicity (self-identified Latinx), and/or Medicaid beneficiary. Exclusion Criteria: * Individuals unable to conduct visits and complete surveys via computer or phone, * Younger than 18 years * Individuals unable to communicate (reading, writing, speaking) in English, Spanish or Haitian Creole * multifetal pregnancy * gestational age less than 24 weeks at delivery * known major fetal anomaly in current pregnancy * known fetal demise * on hemodialysis * active user of IV drugs * active suicidal ideation with intent and plan * known primary psychotic disorder * plans to move out of the area within 6 months

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Maternal Death postpartum depression Psychological Well-Being Systemic Racism

As listed by the trial registrant

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

Cardiac event Postpartum depression (PPD)

Contacts and locations

Locations

  • New York City Health + Hospitals/ Queens

    Jamaica, New York, 11432, United States

  • New York Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York, 11215, United States

  • NewYork-Presbyterian Allen Hospital

    New York, New York, 10034, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.