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 range

18 Years

Sex

ALL

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

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

Flow-mediated dilation of the brachial artery (FMD) %

Timeframe: Baseline

Trial details

NCT IDNCT03778307

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Trauma trials