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Could a smartphone program ease pregnancy stress?

NCT ID NCT04018625

Symptom relief Sponsor: Stony Brook 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial explores whether two different internet-delivered programs can help pregnant women reduce stress, anxiety, and depression. One program teaches cognitive-behavioral stress management skills, while the other is a supportive group discussion. Researchers will measure changes in stress and mood after the programs and check if they might also benefit infant health.

What this could mean

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

Active substance
An 8-session online cognitive-behavioral stress management program (SMART Mom) compared to an 8-session online support group (Mama Support).
What this could lead to
If effective, this could provide a scalable, accessible way to reduce stress and improve mental health in pregnant women, potentially benefiting both mothers and babies.
What could go wrong
This is a small, early-stage feasibility study, so results may not be conclusive. The online format may not suit everyone, and the support group comparison may also show benefits, making it hard to isolate the specific effect.

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

63 people

The number who actually took part.

Started

Apr 2021

Finished

Jun 2023

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: * \<21 weeks pregnant with medically confirmed viability * Speak, read and write in English fluently, * Endorse elevated levels of prenatal maternal stress (PNMS; i.e., New Prenatal Distress Questionnaire Score \> 19). Exclusion Criteria: * Current enrollment in individual or group psychotherapy * Current un-managed serious mental illness including bipolar disorder and psychosis * History of previous suicide attempt * Inappropriate for participation in group therapy format as determined by study director

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder perinatal asphyxia pregnancy disorder Stress, Psychological

As listed by the trial registrant

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

Anxiety Perinatal depression Pregnancy related Stress, psychological

Contacts and locations

Locations

  • Stony Brook University, Department of Psychiatry

    Stony Brook, New York, 11794, United States

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