Key Dimensions of PTSD and ED

NCT ID: NCT03778307

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 168 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-20
• Study Completion Date: 2025-06-30

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).

Conditions

Trauma; PTSD; Endothelial Dysfunction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Trauma exposed without PTSD

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

Psychophysiological fear conditioning and extinction task

Intervention Type: BEHAVIORAL

Behavioral task to assess psychophysiological measures of fear

Eyetracking task

Intervention Type: BEHAVIORAL

Behavioral task to assess dysphoria-relevant attention allocation

Trauma exposed with PTSD

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

Psychophysiological fear conditioning and extinction task

Intervention Type: BEHAVIORAL

Behavioral task to assess psychophysiological measures of fear

Eyetracking task

Intervention Type: BEHAVIORAL

Behavioral task to assess dysphoria-relevant attention allocation

Interventions

Psychophysiological fear conditioning and extinction task

Behavioral task to assess psychophysiological measures of fear

Intervention Type: BEHAVIORAL

Eyetracking task

Behavioral task to assess dysphoria-relevant attention allocation

Intervention Type: BEHAVIORAL

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

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Jennifer A. Sumner, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer A Sumner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33952541 (View on PubMed)

Other Identifiers

R01HL139614

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAR8563

Identifier Type: -

Identifier Source: org_study_id