Key Dimensions of PTSD and ED (NCT03778307) | Clinical Trial Compass
CompletedNot Applicable
Key Dimensions of PTSD and ED
United States168 participantsStarted 2019-11-20
Plain-language summary
This study will test whether endothelial dysfunction could be the early subclinical mechanism by which posttraumatic stress disorder (PTSD) increases cardiovascular disease (CVD) risk, and whether posttraumatic fear-a key component of PTSD-or another PTSD dimension could be the target to offset that risk. The results of this study may help trauma-exposed individuals who are at risk of having CVD events.
Who can participate
Age range18 Years
SexALL
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:
* Aged 18+ years
* History of exposure to a psychological trauma (e.g., natural disaster, physical assault)
* Fluent in English
* Willing to and capable of providing informed consent
Additional Inclusion Criteria for the PTSD Group
* Diagnosed with current PTSD (duration of at least 1 month) using the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual 5th Edition (DSM-5) (CAPS-5) at the diagnostic interview assessment
Exclusion Criteria:
* History of CVD (i.e., diagnosis of myocardial infarction, unstable angina, heart failure, peripheral artery disease, or stroke)
* Deemed unable to comply with the protocol (either self-selected or by indicating during screening that could not complete all requested tasks)
* Current bipolar disorder or psychotic disorder
* Mild or more severe cognitive impairment \[Mini-Mental State Exam (MMSE)3 score ≤18\]
* Current moderate or severe substance use disorder
* Acute, unstable, or severe medical disorder or pregnancy
* Deemed to need immediate psychiatric intervention (e.g., active suicidality)
* Use of antipsychotic, mood stabilizer, antidepressant, or stimulant medication in the past 4 weeks
* Daily benzodiazepine use in the past 2 weeks
Additional Exclusion Criteria for the Trauma-Exposed Matched Control Group
* Current or past diagnosis of any DSM-5 psychiatric disorder
* CAPS-5 total score ≥25
What they're measuring
1
Flow-mediated dilation of the brachial artery (FMD) %