Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT04264520
Status:
TERMINATED
Last Update Posted:
2024-10-24
First Post:
2020-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI changed institutions and was no longer able to continue project.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: