TerminatedNot Applicable

Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women

Stopped: PI changed institutions and was no longer able to continue project.

United States5 participantsStarted 2020-06-05

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PTSD Checklist for DSM-5 (PCL-5) Total Scores

Timeframe: Baseline to follow-up (follow-up will occur at one-month following the baby's birth)

Baby's Weight at Birth in Pounds/Ounces

Timeframe: Baseline to birth of baby.

Total Gestation Length in Weeks

Timeframe: Baseline to birth of baby.

Baby's APGAR Score at Birth

Timeframe: Baseline to birth of baby.

Trial details

NCT IDNCT04264520

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-23

View on ClinicalTrials.gov More Perinatal Problems trials

Plain-language summary

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

PTSD Checklist for DSM-5 (PCL-5) Total Scores

Timeframe: Baseline to follow-up (follow-up will occur at one-month following the baby's birth)

Baby's Weight at Birth in Pounds/Ounces

Timeframe: Baseline to birth of baby.

Total Gestation Length in Weeks

Timeframe: Baseline to birth of baby.

Baby's APGAR Score at Birth

Timeframe: Baseline to birth of baby.