NCT03756545

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

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

January 20, 2015

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2020

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

5.1 years

First QC Date

November 25, 2018

Last Update Submit

March 11, 2020

Conditions

PTSDTrauma

Outcome Measures

Primary Outcomes (1)

  • 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).

    one-, six- and fourteen months following a traumatic event

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Related Publications (3)

  • Ben-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.

    PMID: 36628514DERIVED

  • Sheynin 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.

    PMID: 34098066DERIVED

  • Ben-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.

    PMID: 31973980DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Arieh Y Shalev, Prof.

    Department of Psychiatry, NYU Langone Medical Center, New York, NY, United States

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
14 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Talma Hendler

Study Record Dates

First Submitted

November 25, 2018

First Posted

November 28, 2018

Study Start

January 20, 2015

Primary Completion

March 11, 2020

Study Completion

March 11, 2020

Last Updated

March 13, 2020

Record last verified: 2020-03

Locations

IL(1)