Key Dimensions of PTSD and ED

NCT03778307 | Completed

• 2 other identifiers: AAAR8563R01HL139614
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD; Endothelial Dysfunction; Trauma

Keywords

Trauma; PTSD; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

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

  FMD is the percent difference in diameter of the brachial artery, before and after occlusion. Impaired endothelial function occurs when blood vessels are unable to dilate fully in response to nitric oxide synthesis and release, which is manifested as impaired endothelium-dependent vasodilation (i.e., lower FMD). Lower FMD has been associated with the degree of coronary atherosclerosis and predicts CVD events.

  Baseline

Secondary Outcomes (2)

• Circulating EMPs expressing CD62E

  Baseline

• Circulating EMPs expressing CD31

  Baseline

Study Arms (2)

Trauma exposed without PTSD

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

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

Trauma exposed with PTSD

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

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

Interventions

Psychophysiological fear conditioning and extinction task BEHAVIORAL

Behavioral task to assess psychophysiological measures of fear

Trauma exposed with PTSD; Trauma exposed without PTSD

Eyetracking task BEHAVIORAL

Behavioral task to assess dysphoria-relevant attention allocation

Trauma exposed with PTSD; Trauma exposed without PTSD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Trauma-exposed adults without a history of cardiovascular disease recruited from the community

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• Current or past diagnosis of any DSM-5 psychiatric disorder
• CAPS-5 total score ≥25

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• 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.

  PMID: 33952541 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples for inflammatory and oxidative stress biomarkers; a blood sample for DNA collection is an optional aspect of this study

MeSH Terms

Conditions

Wounds and Injuries; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jennifer A Sumner, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 19, 2018
• Study Start: November 20, 2019
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)