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NCT04992767 · ClinicalTrials.gov registry record · NA
Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy
A NA study of Posttraumatic Stress Disorder and Pregnancy Related, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT04992767 is a NA study of Posttraumatic Stress Disorder and Pregnancy Related that has completed, run by University of Illinois at Chicago. The registered enrollment target is 31 participants, below the 112-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04992767, a NA study of Posttraumatic Stress Disorder and Pregnancy Related, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators will design, construct, and pilot a prototype of a trauma-informed online intervention, which will be called "SunnysideFlex," that functionally integrates a web-based intervention targeting skills to decrease symptoms of PTSD and better manage mood during and after pregnancy. SunnysideFlex will build upon the previously IRB-approved "Sunnyside" intervention which targeted skills to manage mood through an interactive website with didactic material and tools. Women in weeks 16-28 of their pregnancy who self-report symptoms of PTSD will be randomized to one of three study groups: (1) SunnysideFlex, (2) the original Sunnyside intervention (active control), or (3) treatment as usual (TAU). The SunnysideFlex intervention will consist of 6 weeks of trauma-informed online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. Outcomes will be measured at baseline, post-intervention, 6 weeks postpartum, and 12 weeks postpartum. SunnysideFlex has the potential to provide a novel paradigm for improving maternal and child health outcomes in high-risk, trauma-exposed women.
Conditions Studied
Interventions
- BEHAVIORAL Sunnyside
- BEHAVIORAL SunnysideFlex
Study Locations (1)
Illinois
- University of Illinois Department of Psychology - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2022-10-21 |
| Est. Completion | 2024-10-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04992767
The ClinicalTrials.gov registry entry for NCT04992767 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 112-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (72% lower). The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Posttraumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Sunnyside is the first listed.
NCT04992767 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT04992767 about?
NCT04992767 is a clinical study titled "Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy". The investigators will design, construct, and pilot a prototype of a trauma-informed online intervention, which will be called "SunnysideFlex," that functionally integrates a web-based intervention targeting skills to decrease symptoms of PTSD and better manage mood during and after pregnancy. Sunny...
What is the current status of trial NCT04992767?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2022-10-21. Estimated completion is 2024-10-02.
What conditions does trial NCT04992767 study?
This clinical trial studies the following conditions: Posttraumatic Stress Disorder, Pregnancy Related.
What interventions are being tested in trial NCT04992767?
The interventions under investigation include: Sunnyside (BEHAVIORAL), SunnysideFlex (BEHAVIORAL).
Who is sponsoring clinical trial NCT04992767?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04992767 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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