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NCT04264520 · ClinicalTrials.gov registry record · NA
Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women
A NA study, sponsored by Medical University of South Carolina.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT04264520: Clinical Trial NA study, sponsored by Medical University of South Carolina.
NCT04264520 is a NA study that was terminated before completion, run by Medical University of South Carolina. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04264520, a NA study, was terminated before completion, sponsored by Medical University of South Carolina.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
The current study aims to test a brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms. In this open trial pilot feasibility study, 20 pregnant women in their first trimester will be invited to participate in the study if they endorse elevated PTSD symptoms. Oxytocin and cortisol will be measured at baseline, one month post-intervention, three months post-intervention, and post-delivery to inform the relationship between these hormones, PTSD symptoms, and peripartum/postpartum outcomes. In addition to receiving the psychoeducation + skills intervention during their first trimester, women will be offered a "booster session" intervention following delivery to enhance utilization of skills during a critical period for maternal mental and physical health outcomes.
Primary Outcome
The PCL-5 is a 17-item self-report questionnaire designed to assess PTSD symptoms among civilians. In the current study, PCL-5 total scores will be utilized. Specifically, we will examine the impact of the intervention on change in PCL-5 scores across time (i.e., from baseline to post-delivery follow-up). Scores on the PCL-5 range from 0 to 80, with higher scores indicating more symptoms.
Interventions
- BEHAVIORAL PTSD Psychoeducation + Skills Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-06-05 |
| Est. Completion | 2021-04-23 |
| Phase | NA |
Why NCT04264520 stopped before completion
NCT04264520 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which PTSD Psychoeducation + Skills Intervention is the first listed.
NCT04264520 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04264520 about?
NCT04264520 is a clinical study titled "Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women". The current study aims to test a brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms. In this open trial pilot feasibility study, 20 pregnant women in their first trimester will be invited to participate in the study if they endorse elevated...
What is the current status of trial NCT04264520?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2020-06-05. Estimated completion is 2021-04-23.
What interventions are being tested in trial NCT04264520?
The interventions under investigation include: PTSD Psychoeducation + Skills Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04264520?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04264520's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 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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