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:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT04992767
Eligibility Criteria:
Inclusion Criteria:
* Female
* 18 years and older
* Pregnant and between 16-28 weeks gestation
* Are currently engaged in prenatal care with a healthcare provider (OB/GYN, nurse, midwife, etc.)
* Endorse a history of one or more potentially traumatic events meeting Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) Criterion A for PTSD (i.e., "exposure to actual or threatened death, serious injury, or sexual violence," American Psychological Association \[APA\], p. 271) that is interpersonal in nature (e.g., sexual or physical assault, child abuse/maltreatment, witnessing family violence)
* Endorse a score of 33 or greater on the PTSD Checklist for DSM-5 (PCL-5)
* Have access to a broadband internet connection
* Able to read and speak English
Exclusion Criteria:
* Pregnant with multiples
* Have visual, hearing, voice, or motor impairment that would prevent completion of study procedures
* Have been diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, substance use disorder, or other diagnosis for which participation in this trial is either inappropriate or dangerous based on self-report
* Report currently being in an abusive or unsafe relationship
* Currently receiving treatment (medication or psychotherapy), or have an intention to resume antidepressant medication after delivery (i.e., women who discontinued their medication during pregnancy)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04992767
Study Brief:
Protocol Section:
NCT04992767