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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04264520
Other study ID # 00096405
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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.
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