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Clinical Trials/NCT04651192
NCT04651192
Completed
Not Applicable

Neurological and Psychological Effects of Combat-Related Stress

Tel Aviv University1 site in 1 country100 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Disorder, Posttraumatic
Sponsor
Tel Aviv University
Enrollment
100
Locations
1
Primary Endpoint
Change from baseline - PTSD Checklist for DSM-5 (PCL-5) score
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

The purpose of this study is to determine what is the neurological and cognitive impact of combat exposure and prolonged stress, in the form of service in the Israeli Defense Forces.

Detailed Description

Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. This study aimed to characterize the mental resilience of combat soldiers, and explore the neuro-cognitive impact of prolonged stress, using eye-tracking, MRI and fMRI measurements. Participants will be assessed using questionnaires, cognitive tasks and magnetic imaging at 5 timepoints over the span of 4 years. Outcome measures will be depression, anxiety and post-traumatic scores, as well as dwell time on threat in eye-tracking paradigms tested in previous studies, and blood oxygen level-dependent (BOLD) signals in magnetic resonance imaging (MRI) measurements.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
May 1, 2025
Last Updated
11 months ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yair Bar-Haim

Professor

Tel Aviv University

Eligibility Criteria

Inclusion Criteria

  • Soldiers in the paratroopers brigade or students in Tel-Aviv University;
  • A signed consent form;
  • Hebrew native speakers.

Exclusion Criteria

  • A diagnosis of a neurological disorder (i.e., epilepsy, brain injury);
  • Drug or alcohol abuse;
  • Cannot undergo an MRI scan, due to metal implants or other metallic foreign bodies, claustrophobia, large tattoos or irremovable piercings;
  • Require glasses with a number greater than 7;
  • A diagnosis of psychotic or bipolar disorders.

Outcomes

Primary Outcomes

Change from baseline - PTSD Checklist for DSM-5 (PCL-5) score

Time Frame: 4 years, from time point 1 to time point 5

PCL is questionnaire assessing posttraumatic stress disorder symptoms. It contains 20 items on a severity scale of 0-4, measuring the existence and severity of post-traumatic symptoms. The minimal score, indicating no post-traumatic stress, is 0. The maximal score is 80, indicating extremely severe post-traumatic stress.

Neurological measures - Gray matter volume

Time Frame: 4 years, from time point 1 to time point 5

Gray matter volume, i.e. the density of brain cells in a particular region (outcome to be measured in cm3), to be derived from the MRI scans, and compared between the two groups across the various time points.

Neurological measures - Functional connectivity

Time Frame: 4 years, from time point 1 to time point 5

Functional connectivity, indicating the level of synchronous activity of certain brain regions during rest (temporal correlation is usually expressed as a Pearson's r); Also to be derived from the MRI scans, and compared between the two groups across the various time points.

Neurological measures - Task activations

Time Frame: 4 years, from time point 1 to time point 5

Task activations, and specifically the areas activated during the dot-probe task, and how they change over time (expressed as the level of the BOLD signal strength change during the task). To be derived from the MRI scans, and compared between the two groups across the various time points.

Neurological measures - Structural connectivity

Time Frame: 4 years, from time point 1 to time point 5

Structural connectivity between regions of the brain (Diffusivity is measured as 10-3mm2.s-1) and the properties of the white matter (expressed with Diffusion tensor imaging (DTI) measures, mainly Fractional Anisotropy (FA) and Mean Diffusivity (MD)); Also be derived from the MRI scans, and compared between the two groups across the various time points.

Study Sites (1)

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