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NCT04018625 · ClinicalTrials.gov registry record · NA
The Stony Brook University Calm-Mom Study
A NA study, sponsored by Stony Brook University.
- Completed
- Registry status
- NA
- Development phase
- 79
- Enrollment target
NCT04018625: Completed NA study, sponsored by Stony Brook University.
NCT04018625 is a NA study that has completed, run by Stony Brook University. The registered enrollment target is 79 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04018625, a NA study, has completed, sponsored by Stony Brook University.
- COMPLETED
- Registry status
- NA
- Development phase
- 79 participants
- Enrollment target
Study Summary
The present trial will evaluate the feasibility, acceptability and preliminary efficacy of 2 different internet-delivered programs for prenatal maternal stress. The Stress Managment and Resiliency Training Program (SMART-Mom program), an 8-session Cognitive Behavior Therapy (CBT) based mind body program and the Mama Support Program, an 8-session social support group program. Sixty pregnant women (\<20 weeks Estimated Gestational Age) will be screened and either enrolled in the online SMART Mom Program or the Mama Support Program. Outcomes, including maternal perceived stress, depression, and anxiety will be assessed at post-treatment, three, and six months post program completion. Potential impact on infant health outcomes will be assessed via post-delivery electronic medical record review.
Primary Outcome
The Perceived Stress Scale (PSS-10) is the gold standard measure of subjective stress experiences. Total scores range from 0 to 40; higher scores indicate greater stress or a worse outcome.
Interventions
- BEHAVIORAL SMART Mom
- BEHAVIORAL Mama Support
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2023-06-01 |
| Phase | NA |
What the finished NCT04018625 record still lists
NCT04018625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which SMART Mom is the first listed.
NCT04018625 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04018625 about?
NCT04018625 is a clinical study titled "The Stony Brook University Calm-Mom Study". The present trial will evaluate the feasibility, acceptability and preliminary efficacy of 2 different internet-delivered programs for prenatal maternal stress. The Stress Managment and Resiliency Training Program (SMART-Mom program), an 8-session Cognitive Behavior Therapy (CBT) based mind body pro...
What is the current status of trial NCT04018625?
This trial is currently completed. It is a NA study. The enrollment target is 79 participants. The study started on 2021-04-01. Estimated completion is 2023-06-01.
What interventions are being tested in trial NCT04018625?
The interventions under investigation include: SMART Mom (BEHAVIORAL), Mama Support (BEHAVIORAL).
Who is sponsoring clinical trial NCT04018625?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04018625's enrollment target sits among peer trials
79 1060th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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