Key Dimensions of PTSD and ED

Sponsor
University of California, Los Angeles (Other)
Overall Status
Recruiting
CT.gov ID
NCT03778307
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
200
1
43.3
4.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Psychophysiological fear conditioning and extinction task
  • Behavioral: Eyetracking task

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).

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Key Dimensions of Post-traumatic Stress Disorder (PTSD) and Endothelial Dysfunction (ED)
Actual Study Start Date :
Nov 20, 2019
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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 task to assess psychophysiological measures of fear

Behavioral: Eyetracking task
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

Behavioral: Psychophysiological fear conditioning and extinction task
Behavioral task to assess psychophysiological measures of fear

Behavioral: Eyetracking task
Behavioral task to assess dysphoria-relevant attention allocation

Outcome Measures

Primary Outcome Measures

  1. Flow-mediated dilation of the brachial artery (FMD) % [Baseline]

    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.

Secondary Outcome Measures

  1. Circulating EMPs expressing CD62E [Baseline]

    EMPs expressing CD62E (i.e., endothelial cell activation) and CD31 (i.e., endothelial cell apoptosis) will be measured. Assessments of circulating EMPs will be measured using flow cytometry, and total flow cytometry counts will be converted to the number of EMPs per uL of blood. Higher concentrations of EMPs expressing CD62E and CD31 indicate greater endothelial dysfunction.

  2. Circulating EMPs expressing CD31 [Baseline]

    EMPs expressing CD62E (i.e., endothelial cell activation) and CD31 (i.e., endothelial cell apoptosis) will be measured. Assessments of circulating EMPs will be measured using flow cytometry, and total flow cytometry counts will be converted to the number of EMPs per uL of blood. Higher concentrations of EMPs expressing CD62E and CD31 indicate greater endothelial dysfunction.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCLA Los Angeles California United States 90095

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Jennifer A Sumner, PhD, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jennifer A. Sumner, PhD, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT03778307
Other Study ID Numbers:
  • AAAR8563
  • R01HL139614
First Posted:
Dec 19, 2018
Last Update Posted:
Jul 13, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jennifer A. Sumner, PhD, Assistant Professor, University of California, Los Angeles
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2021