NCT04651192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

6 years

First QC Date

November 24, 2020

Last Update Submit

May 21, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

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

    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.

    4 years, from time point 1 to time point 5

  • Neurological measures - Gray matter volume

    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.

    4 years, from time point 1 to time point 5

  • Neurological measures - Functional connectivity

    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.

    4 years, from time point 1 to time point 5

  • Neurological measures - Structural connectivity

    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.

    4 years, from time point 1 to time point 5

  • Neurological measures - Task activations

    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.

    4 years, from time point 1 to time point 5

Study Arms (2)

Soldiers

50 Israeli Defense Forces (IDF) infantry soldiers, all male, aged 18 years, with Hebrew as the dominant language and no condition excluding an MRI scan.

Other: Combat Exposure

Students

50 Reserve Officer Training Corps (ROTC) undergraduate students at Tel-Aviv University, all male, aged 18-19, with Hebrew as the dominant language and no condition excluding an MRI scan.

Interventions

Soldiers will be exposed to combat as part of their routine military service. The ROTC students will not be exposed to combat.

Soldiers

Eligibility Criteria

Age18 Years - 23 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy 18-year-old Israeli males.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv University

Tel Aviv, 69978, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticStress, Psychological

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Yair Bar-Haim, PhD

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 3, 2020

Study Start

March 1, 2019

Primary Completion

March 1, 2025

Study Completion

May 1, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations