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 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.

Study Overview

• Status: Terminated
• Conditions: Post Partum Depression; Post Traumatic Stress Disorder; Perinatal Problems
• Intervention / Treatment: Behavioral: PTSD Psychoeducation + Skills Intervention

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina Institute of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PTSD Psychoeducation + Skills Intervention	Behavioral: PTSD Psychoeducation + Skills Intervention; A brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Checklist for DSM-5 (PCL-5) Total Scores	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.	Baseline to follow-up (follow-up will occur at one-month following the baby's birth)
Baby's Weight at Birth in Pounds/Ounces	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.	Baseline to birth of baby.
Total Gestation Length in Weeks	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.	Baseline to birth of baby.
Baby's APGAR Score at Birth	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.	Baseline to birth of baby.

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: MUSC Specialized Center of Research Excellence

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2020
• Primary Completion (Actual): April 23, 2021
• Study Completion (Actual): April 23, 2021

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 8, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Trauma and Stressor Related Disorders; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Depression, Postpartum
• Other Study ID Numbers: 00096405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No