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Text messages to stop pregnancy anxiety? new study tests digital prevention

NCT ID NCT07458698

Prevention Sponsor: University of Massachusetts, Worcester 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This pilot study tests a digital program called Reaching Calm, designed to prevent anxiety in pregnant women at higher risk. The program sends text messages and provides web-based exercises to help women cope. Researchers will check if it's easy to use and if it reduces anxiety symptoms, comparing it to usual care. The study involves 60 participants and aims to prepare for a larger trial.

What this could mean

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

Active substance
Digital mental health intervention (Reaching Calm)
What this could lead to
If successful, this could lead to a scalable, low-cost way to prevent anxiety during and after pregnancy, improving mental health for new mothers.
What could go wrong
This is a small pilot study (60 participants) testing feasibility, not effectiveness. The digital format may not engage everyone, and results may not apply to all pregnant women.

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 60 people

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

Started

Aug 2026

Expected to finish

Aug 2029

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: * Receiving prenatal care at participating obstetric practice * Endorsed mild to moderate anxiety (GAD-7 score 5-15) * Currently pregnant (gestational age \<32) * Started Reaching Calm digital intervention, if in intervention group Exclusion Criteria: * Not pregnant * Unable to participate in 60-minute interview * Unwilling to be audio recorded * GAD-7 \<5, or GAD-7≥15 * Adults unable to consent (adults lacking capacity) * Individuals who are not yet adults (infants, children, teenagers) * Prisoners * Non-English-speaking

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Conditions

The condition(s) this trial relates to.

perinatal asphyxia

As listed by the trial registrant

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

Anxiety sensitivity Perinatal anxiety Perinatal depression

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

  • UMass Memorial Medical Group - Montachusett Women's Health

    RECRUITING

    Leominster, Massachusetts, 01453, United States

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