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One-hour talk before c-section may stop postpartum anxiety and trauma

NCT ID NCT06949813

Prevention Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a brief, one-hour counseling session designed to prevent mood, anxiety, and trauma symptoms after cesarean delivery. The session includes education about anxiety sensitivity and a short exposure to the operating room environment. Researchers will refine the program with input from patients, clinicians, and staff, then test it in a small pilot trial with 80 high-risk pregnant women to see if it works and is practical for larger hospitals.

What this could mean

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

Active substance
Brief behavioral intervention (CARE-CD: Comfort, Agency, Readiness, Empowerment for Cesarean Delivery)
What this could lead to
If it works, this could offer a low-cost, one-hour session to prevent mental health problems after C-sections, reducing the need for lengthy treatments.
What could go wrong
This is a small, early-stage pilot study (80 participants) focused on refining the intervention and testing feasibility, not yet proving effectiveness. Results may not apply to all hospitals or patients.

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 80 people

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

Started

Oct 2025

Expected to finish

Apr 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: * Pregnant Patients at 22-37 weeks gestation * Single or multiple gestation * Nulliparous or multiparous (with prior vaginal or cesarean delivery) * Antepartum admission for at least 3 days * High-risk pregnancy due to maternal/fetal comorbidities * Anticipated cesarean delivery at the University of Colorado Exclusion Criteria: * Lack of capacity to consent * Medical factors prohibiting participation in the intervention as determined by the inpatient obstetric medical team. * Anticipated cesarean within 7 days of enrollment

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Conditions

The condition(s) this trial relates to.

anxiety disorder

As listed by the trial registrant

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

Anxiety in pregnancy Mood disorder due to specified medical condition

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

  • University of Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

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