Could a smartphone program ease pregnancy stress?
NCT ID NCT04018625
The trial has finished. Results may not be published yet.
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
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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
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63 people
The number who actually took part.
- Started
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Apr 2021
- Finished
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Jun 2023
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Stony Brook University, Department of Psychiatry
Stony Brook, New York, 11794, United States
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