Clinical trial NCT03778307: Key Dimensions of PTSD and ED
Official title: Key Dimensions of Post-traumatic Stress Disorder (PTSD) and Endothelial Dysfunction (ED)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Trauma
PTSD
Endothelial Dysfunction
Keywords: Trauma
PTSD
Endothelial Dysfunction
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-12-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trauma-exposed adults without a history of cardiovascular disease recruited from the community

Brief 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.

Detailed description: Posttraumatic stress disorder (PTSD) increases risk of incident cardiovascular disease (CVD) by 25-50%. Most individuals (50-90%) experience a traumatic event in their lifetime, and PTSD is the fifth most common psychiatric disorder. Experts have now called for increased CVD surveillance after trauma and for PTSD treatment trials powered to reduce CVD risk. However, both CVD risk and PTSD are complex phenomena that likely interact in nuanced ways. This study will determine which PTSD dimension(s) contribute to endothelial dysfunction, one of the earliest modifiable precursors to CVD. The investigators will examine cross-sectional and longitudinal associations of PTSD and its underlying dimensions with functional and, secondarily, cellular measures of endothelial dysfunction (FMD and circulating endothelial cell-derived microparticles, respectively) in a community-dwelling sample of CVD-free adult men and women with a history of trauma (50% with current PTSD).

Eligibility criteria: 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

Primary outcomes:
measure: Flow-mediated dilation of the brachial artery (FMD) %
timeFrame: Baseline
Secondary outcomes:
measure: Circulating EMPs expressing CD62E
timeFrame: Baseline
measure: Circulating EMPs expressing CD31
timeFrame: Baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Jennifer A Sumner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cleveland S, Reed K, Thomas JL, Ajijola OA, Ebrahimi R, Hsiai T, Lazarov A, Montoya AK, Neria Y, Shimbo D, Wolitzky-Taylor K, Sumner JA. Key dimensions of post-traumatic stress disorder and endothelial dysfunction: a protocol for a mechanism-focused cohort study. BMJ Open. 2021 May 5;11(5):e043060. doi: 10.1136/bmjopen-2020-043060.