Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women

Post Traumatic Stress Disorder Clinical Trial

Official title:

Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04264520
• Other study ID #: 00096405
• Status: Terminated
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: April 23, 2021

Study information

• Verified date: September 2021
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 23, 2021
• Est. primary completion date: April 23, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression, Postpartum
• Perinatal Problems
• Post Partum Depression
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• PTSD Psychoeducation + Skills Intervention
A brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms.

Locations

Country	Name	City	State
United States	Medical University of South Carolina Institute of Psychiatry	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	MUSC Specialized Center of Research Excellence

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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.
Primary	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.
Primary	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.