Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women
Primary Purpose
Perinatal Problems, Post Traumatic Stress Disorder, Post Partum Depression
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PTSD Psychoeducation + Skills Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Perinatal Problems
Eligibility Criteria
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.
Sites / Locations
- Medical University of South Carolina Institute of Psychiatry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PTSD Psychoeducation + Skills Intervention
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04264520
First Posted
February 3, 2020
Last Updated
September 22, 2021
Sponsor
Medical University of South Carolina
Collaborators
MUSC Specialized Center of Research Excellence
1. Study Identification
Unique Protocol Identification Number
NCT04264520
Brief Title
Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women
Official Title
Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
PI changed institutions and was no longer able to continue project.
Study Start Date
June 5, 2020 (Actual)
Primary Completion Date
April 23, 2021 (Actual)
Study Completion Date
April 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
MUSC Specialized Center of Research Excellence
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Problems, Post Traumatic Stress Disorder, Post Partum Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open Label Pilot Trial (no control group)
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PTSD Psychoeducation + Skills Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
PTSD Psychoeducation + Skills Intervention
Intervention Description
A brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms.
Primary Outcome Measure Information:
Title
PTSD Checklist for DSM-5 (PCL-5) Total Scores
Description
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.
Time Frame
Baseline to follow-up (follow-up will occur at one-month following the baby's birth)
Title
Baby's Weight at Birth in Pounds/Ounces
Description
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.
Time Frame
Baseline to birth of baby.
Title
Total Gestation Length in Weeks
Description
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.
Time Frame
Baseline to birth of baby.
Title
Baby's APGAR Score at Birth
Description
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.
Time Frame
Baseline to birth of baby.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Intervention for pregnant women, so only women can be included.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Medical University of South Carolina Institute of Psychiatry
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women
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