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NCT04992767 · ClinicalTrials.gov registry record · NA
Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy
A NA study of Post Traumatic 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: Completed NA study of Post Traumatic Stress Disorder and Pregnancy Related, sponsored by University of Illinois at Chicago.
NCT04992767 is a NA study of Post Traumatic Stress Disorder and Pregnancy Related that has completed, run by University of Illinois at Chicago. The registered enrollment target is 31 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04992767, a NA study of Post Traumatic 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.
Primary Outcome
The PCL-5 is a well validated screening tool for assessing PTSD symptoms and probable PTSD diagnosis. the PCL-5 checklist assesses frequency of past 30-day PTSD symptoms in reference to an individual's self-identified worst traumatic event. A total score of 33 or greater represents a positive PTSD screen and is the cut-off employed in the current study.
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 |
What the finished NCT04992767 record still lists
NCT04992767 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Sunnyside is the first listed.
NCT04992767 reports a single indexed study location in 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: Post Traumatic 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.
Learn More About Clinical Trials
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Where NCT04992767's enrollment target sits among peer trials
31 208th of 262 higher than 54 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder 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.
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