Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women

NCT04264520 | Terminated DMC

• 1 other identifier: 00096405
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Problems; Post Traumatic Stress Disorder; Post Partum Depression

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (1)

PTSD Psychoeducation + Skills Intervention

EXPERIMENTAL

Behavioral: PTSD Psychoeducation + Skills Intervention

Interventions

PTSD Psychoeducation + Skills Intervention BEHAVIORAL

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

PTSD Psychoeducation + Skills Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Intervention for pregnant women, so only women can be included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Fluent in English

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• MUSC Specialized Center of Research Excellence: collaborator

Study Sites (1)

Medical University of South Carolina Institute of Psychiatry

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression, Postpartum

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Label Pilot Trial (no control group)

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 11, 2020
• Study Start: June 5, 2020
• Primary Completion: April 23, 2021
• Study Completion: April 23, 2021
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)