Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women

Not Applicable

Terminated

• Conditions: Post Traumatic Stress Disorder; Perinatal Problems; Post Partum Depression
• Interventions: Behavioral: PTSD Psychoeducation + Skills Intervention

• Registration Number: NCT04264520
• Lead Sponsor: Medical University of South Carolina

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

Not available

Study Timeline

• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-08
• Study First Posted: 2020-02-11
• Study Start: 2020-06-05
• Primary Completion: 2021-04-23
• Study Completion: 2021-04-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

• 18-40 years old
• Fluent in English

Exclusion Criteria

• Active and severe domestic violence
• Evidence of a significant mental illness or current substance use disorder that would impede the completion of the intervention
• Suicidal individuals deemed at immediate danger or risk (i.e., requiring immediate hospitalization or treatment)
• Women who smoke
• Women who have a metabolic or endocrine disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PTSD Psychoeducation + Skills Intervention	PTSD Psychoeducation + Skills Intervention	-

Primary Outcome Measures

Name	Time	Method
PTSD Checklist for DSM-5 (PCL-5) Total Scores	Baseline to follow-up (follow-up will occur at one-month following the baby's birth)	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.
Baby's Weight at Birth in Pounds/Ounces	Baseline to birth of baby.	Each baby's weight (in pounds/ounces) will be derived from the online medical record following delivery. This outcome will be used to determine the relationship between maternal PTSD symptoms (as indexed by the PCL-5 total scores--above) and infant weight at birth.
Total Gestation Length in Weeks	Baseline to birth of baby.	The total gestation length, in weeks, will be derived from the online medical record following the baby's birth. This outcome will be used to determine the relationship between maternal PTSD symptoms (as indexed by the PCL-5 total scores--above) and total weeks gestation at birth.
Baby's APGAR Score at Birth	Baseline to birth of baby.	Each baby's APGAR score will be derived from the online medical record following delivery. APGAR scores range from 0-10, with higher scores indicating better health at birth for baby. APGAR scores will be used to determine the relationship between maternal PTSD symptoms (as indexed by the PCL-5 total scores--above) and infant health at birth.

Trial Locations

Locations (1)

Medical University of South Carolina Institute of Psychiatry; 🇺🇸 Charleston, South Carolina, United States