Key Dimensions of PTSD and ED

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Endothelial Dysfunction; PTSD; Trauma

Treatments: Behavioral: Psychophysiological fear conditioning and extinction task; Behavioral: Eyetracking task

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03778307

AAAR8563

R01HL139614 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

168 participants in 2 patient groups

Trauma exposed without PTSD

Description:

Individuals with a history of trauma exposure who do not have current PTSD

Treatment:

Behavioral: Eyetracking task

Behavioral: Psychophysiological fear conditioning and extinction task

Trauma exposed with PTSD

Description:

Individuals with a history of trauma exposure and a current diagnosis of PTSD

Treatment:

Behavioral: Eyetracking task

Behavioral: Psychophysiological fear conditioning and extinction task