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Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women

Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04264520
Enrollment
5
Registered
2020-02-11
Start date
2020-06-05
Completion date
2021-04-23
Last updated
2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal Problems, Post Partum Depression, Post Traumatic Stress Disorder

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.

Interventions

BEHAVIORALPTSD Psychoeducation + Skills Intervention

A brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms.

Sponsors

MUSC Specialized Center of Research Excellence
CollaboratorUNKNOWN
Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Open Label Pilot Trial (no control group)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
PTSD Checklist for DSM-5 (PCL-5) Total ScoresBaseline 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/OuncesBaseline 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 WeeksBaseline 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 BirthBaseline 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026