PTSDNCT03756545
Neurobehavioral Moderators of Post-traumatic Disease Trajectories
An observational study of PTSD and Trauma, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The research goal is to uncover the neurocognitive moderators of PTSD trajectories, by documenting clinical symptoms, cognitive functioning, and brain structure and function, one-, six- and fourteen months following a traumatic event, in a large population of survivors at initial high risk for PTSD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- How many people
- 173 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Jan 2015to 11 Mar 2020
- How long will I take part?
- 14 Months
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult civilians admitted to Tel-Aviv Sourasky Medical Center's Emergency Room (ER), following a potentially traumatic incident. The initial screening will be done via telephone-based structured interviews within 10 days of ER admission, in order to confirm the occurrence of psychologically traumatic event, identify \& assess those expressing initial Acute Stress Disorder (ASD) symptoms.
Who may be able to join
- Age 18 - 65 years
- Able to read and comprehend Hebrew
- Arrived in the ER because of one of the following: car accidents, terrorist attacks, work accidents, home accidents, burns, physical assault, large-scale disaster.
Who cannot join
- Individuals with known claustrophobia
- Individuals with history of substance abuse
- Individuals with current or past psychotic or bipolar I disorder
- Individuals with chronic PTSD at the time of the current trauma
- Individuals on psychotropic medication or recreational drugs in the week that precedes the MRI
- Individuals with hearing problems
- Individuals with head trauma with coma exceeding 30 minutes
- Individuals which can't perform MRI due to safety reasons (e.g. irremovable metals in their body)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurobehavioral Moderators of Post-traumatic Disease Trajectories: Prospective MRI Study of Recent Trauma Survivors
The research goal is to uncover the neurocognitive moderators of PTSD trajectories, by documenting clinical symptoms, cognitive functioning, and brain structure and function, one-, six- and fourteen months following a traumatic event, in a large population of survivors at initial high risk for PTSD.
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CAPS Total Scores
The Clinician-Administered PTSD Scale, used to assess PTSD diagnostic status and symptom severity. CAPS total symptom severity score is calculated by summing severity scores for all PTSD symptoms. We use both CAPS-V (according to DSM-4) and CAPS-5 (according to DSM-5).
Measured: one-, six- and fourteen months following a traumatic event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start20 Jan 2015
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
- Target duration
- 14 Months
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- New York University, Texas A&M University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- Arieh Y Shalev, Prof., Principal investigator, Department of Psychiatry, NYU Langone Medical Center, New York, NY, United States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756545
- Sponsor's protocol ID
- 0207-14-TLV
- Other IDs
- R01MH103287
- Status last verified
- Mar 2020
- First submitted
- 25 Nov 2018
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ben-Zion Z, Basol EZ, Simon AJ, Abargil M, Samonek K, Paterson M, Spiller TR, Duek O, Just S, Preller K, Keynan JN, Admon R, Liberzon I, Shalev AY, Hendler T, Levy I, Joormann J, Scheinost D, Harpaz-Rotem I. Dissecting Fear and Emotional Pain in Posttraumatic Stress Disorder: From Symptom Networks to Neural Signatures. Biol Psychiatry. 2026 Jul 1;100(1):111-121. doi: 10.1016/j.biopsych.2025.11.016. Epub 2025 Nov 29.
PubMed 41319905Ben-Zion Z, Spiller TR, Keynan JN, Admon R, Levy I, Liberzon I, Shalev AY, Hendler T, Harpaz-Rotem I. Evaluating the Evidence for Brain-Based Biotypes of Psychiatric Vulnerability in the Acute Aftermath of Trauma. Am J Psychiatry. 2023 Feb 1;180(2):146-154. doi: 10.1176/appi.ajp.20220271. Epub 2023 Jan 11.
PubMed 36628514Sheynin S, Wolf L, Ben-Zion Z, Sheynin J, Reznik S, Keynan JN, Admon R, Shalev A, Hendler T, Liberzon I. Deep learning model of fMRI connectivity predicts PTSD symptom trajectories in recent trauma survivors. Neuroimage. 2021 Sep;238:118242. doi: 10.1016/j.neuroimage.2021.118242. Epub 2021 Jun 5.
PubMed 34098066Ben-Zion Z, Artzi M, Niry D, Keynan NJ, Zeevi Y, Admon R, Sharon H, Halpern P, Liberzon I, Shalev AY, Hendler T. Neuroanatomical Risk Factors for Posttraumatic Stress Disorder in Recent Trauma Survivors. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Mar;5(3):311-319. doi: 10.1016/j.bpsc.2019.11.003. Epub 2019 Nov 20.
PubMed 31973980
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobehavioral Moderators of Post-traumatic Disease Trajectories: Prospective MRI Study of Recent Trauma Survivors
- ClinicalTrials.gov ID
- NCT03756545
- Acronym / sponsor ID
- 0207-14-TLV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- New York University, Texas A&M University, National Institute of Mental Health (NIMH)
- Study start
- 20 Jan 2015 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 28 Nov 2018 (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 research goal is to uncover the neurocognitive moderators of PTSD trajectories, by documenting clinical symptoms, cognitive functioning, and brain structure and function, one-, six- and fourteen months following a traumatic event, in a large population of survivors at initial high risk for PTSD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult civilians admitted to Tel-Aviv Sourasky Medical Center's Emergency Room (ER), following a potentially traumatic incident. The initial screening will be done via telephone-based structured interviews within 10 days of ER admission, in order to confirm the occurrence of psychologically traumatic event, identify \& assess those expressing initial Acute Stress Disorder (ASD) symptoms.
Key inclusion criteria (3 listed)
- Age 18 - 65 years
- Able to read and comprehend Hebrew
- Arrived in the ER because of one of the following: car accidents, terrorist attacks, work accidents, home accidents, burns, physical assault, large-scale disaster.
Key exclusion criteria (8 listed)
- Individuals with known claustrophobia
- Individuals with history of substance abuse
- Individuals with current or past psychotic or bipolar I disorder
- Individuals with chronic PTSD at the time of the current trauma
- Individuals on psychotropic medication or recreational drugs in the week that precedes the MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in CAPS Total Scores
Time frame: one-, six- and fourteen months following a traumatic event
The Clinician-Administered PTSD Scale, used to assess PTSD diagnostic status and symptom severity. CAPS total symptom severity score is calculated by summing severity scores for all PTSD symptoms. We use both CAPS-V (according to DSM-4) and CAPS-5 (according to DSM-5).
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 13 Mar 2020.
- Derived from this study: PubMed 41319905Ben-Zion Z, Basol EZ, Simon AJ, Abargil M, Samonek K, Paterson M, Spiller TR, Duek O, Just S, Preller K, Keynan JN, Admon R, Liberzon I, Shalev AY, Hendler T, Levy I, Joormann J, Scheinost D, Harpaz-Rotem I. Dissecting Fear and Emotional Pain in Posttraumatic Stress Disorder: From Symptom Networks to Neural Signatures. Biol Psychiatry. 2026 Jul 1;100(1):111-121. doi: 10.1016/j.biopsych.2025.11.016. Epub 2025 Nov 29.
- Derived from this study: PubMed 36628514Ben-Zion Z, Spiller TR, Keynan JN, Admon R, Levy I, Liberzon I, Shalev AY, Hendler T, Harpaz-Rotem I. Evaluating the Evidence for Brain-Based Biotypes of Psychiatric Vulnerability in the Acute Aftermath of Trauma. Am J Psychiatry. 2023 Feb 1;180(2):146-154. doi: 10.1176/appi.ajp.20220271. Epub 2023 Jan 11.
- Derived from this study: PubMed 34098066Sheynin S, Wolf L, Ben-Zion Z, Sheynin J, Reznik S, Keynan JN, Admon R, Shalev A, Hendler T, Liberzon I. Deep learning model of fMRI connectivity predicts PTSD symptom trajectories in recent trauma survivors. Neuroimage. 2021 Sep;238:118242. doi: 10.1016/j.neuroimage.2021.118242. Epub 2021 Jun 5.
- Derived from this study: PubMed 31973980Ben-Zion Z, Artzi M, Niry D, Keynan NJ, Zeevi Y, Admon R, Sharon H, Halpern P, Liberzon I, Shalev AY, Hendler T. Neuroanatomical Risk Factors for Posttraumatic Stress Disorder in Recent Trauma Survivors. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Mar;5(3):311-319. doi: 10.1016/j.bpsc.2019.11.003. Epub 2019 Nov 20.
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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.
Arieh Y Shalev, Prof. principal investigator
Department of Psychiatry, NYU Langone Medical Center, New York, NY, United States
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 PTSD and Trauma, run by Tel-Aviv Sourasky Medical Center 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 8 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 13 Mar 2020. 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 in CAPS Total Scores (time frame: one-, six- and fourteen months following a traumatic event). 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 NCT03756545, which also lists 4 linked publications.
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 13 Mar 2020.