Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT04525469
Eligibility Criteria:
Inclusion:
* 18 years of age or older
* Fluent in English
* History of a DSM-V PTSD criterion A trauma at least 3 months prior to current pregnancy (a person has experienced, witnessed, or been confronted with an event or events that involve actual or threatened death or serious injury, or threat of physical integrity to oneself or others)
* A score of 33 or higher on the PTSD Checklist for the DSM-V with Life Events Checklist for DSM-5 and Criterion A.
Exclusion:
* Current manic or psychotic symptoms or primary psychotic diagnosis
* Serious cognitive impairment
* Concurrent psychotherapy
* Unstable dose of psychotropic medications (must be stable for 6 weeks)
* Serious medical complications of pregnancy (e.g., pre-eclampsia, HELLP syndrome, diagnosed fetal anomaly or death, threatened preterm birth, hospitalization for hypertensive disorders of pregnancy, unstable diabetes, premature rupture of membranes, preterm labor)
* Significant suicidal ideation
* Current legal actions related to trauma
* Patient will be 27 gestational weeks or more at the time of the eligibility session
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04525469
Study Brief:
Protocol Section:
NCT04525469