Stress Disorder, PosttraumaticNCT04651192
Neurological and Psychological Effects of Combat-Related Stress
An observational study of Stress Disorder, Posttraumatic and Stress, Psychological, run by Tel Aviv University at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 23 years, men only
- Conditions the study is for
- Stress Disorder, Posttraumatic, Stress, Psychological
- What is being tested?
- Combat Exposure
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2019to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 23 years
- Men only
- No healthy volunteers
- Adult
Study population: Healthy 18-year-old Israeli males.
Who may be able to join
- Soldiers in the paratroopers brigade or students in Tel-Aviv University;
- A signed consent form;
- Hebrew native speakers.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Combat Exposure
- Medical subject headings
- Stress Disorders, Post-Traumatic, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combat ExposureOther
Soldiers will be exposed to combat as part of their routine military service. The ROTC students will not be exposed to combat.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 years, from time point 1 to time point 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Mar 2019
- Primary completion1 Mar 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorder, PosttraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Corps, Israel Defense Force
- Responsible party
- Principal investigator, Yair Bar-Haim, Tel Aviv University
- Investigators
- Yair Bar-Haim, PhD, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651192
- Sponsor's protocol ID
- TAUatm
- Status last verified
- May 2025
- First submitted
- 24 Nov 2020
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zalmenson T, Yair N, Azriel O, Shamai-Leshem D, Alon Y, Levinstein Y, Ben-Yehuda A, Tetse-Laur L, Rotschield J, Aviad Beer Z, Talmon A, Pine DS, Bliese PD, Bar-Haim Y. Threat processing and PTSD symptom progression over repeated combat deployments. Eur J Psychotraumatol. 2026 Dec;17(1):2666009. doi: 10.1080/20008066.2026.2666009. Epub 2026 Jun 2.
PubMed 42227351
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological and Psychological Effects of Combat-Related Stress
- ClinicalTrials.gov ID
- NCT04651192
- Acronym / sponsor ID
- TAUatm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Medical Corps, Israel Defense Force
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soldiers | – | Other: Combat Exposure50 Israeli Defense Forces (IDF) infantry soldiers, all male, aged 18 years, with Hebrew as the dominant language and no condition excluding an MRI scan. |
| 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. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Healthy 18-year-old Israeli males.
Key inclusion criteria (3 listed)
- Soldiers in the paratroopers brigade or students in Tel-Aviv University;
- A signed consent form;
- Hebrew native speakers.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combat ExposureSoldiers will be exposed to combat as part of their routine military service. The ROTC students will not be exposed to combat. | Other | Soldiers |
Primary outcome
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 - 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Derived from this study: PubMed 42227351Zalmenson T, Yair N, Azriel O, Shamai-Leshem D, Alon Y, Levinstein Y, Ben-Yehuda A, Tetse-Laur L, Rotschield J, Aviad Beer Z, Talmon A, Pine DS, Bliese PD, Bar-Haim Y. Threat processing and PTSD symptom progression over repeated combat deployments. Eur J Psychotraumatol. 2026 Dec;17(1):2666009. doi: 10.1080/20008066.2026.2666009. Epub 2026 Jun 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yair Bar-Haim, PhD principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorder, Posttraumatic and Stress, Psychological, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline - PTSD Checklist for DSM-5 (PCL-5) score (time frame: 4 years, from time point 1 to time point 5). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04651192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.