Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women

Study Overview
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Brief Summary
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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.

Official Title
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Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women

Conditions
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Perinatal Problems, Post Traumatic Stress Disorder, Post Partum Depression

Intervention / Treatment
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* Behavioral: PTSD Psychoeducation + Skills Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open Label Pilot Trial (no control group)
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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. |