Neurobehavioral Moderators of Post-traumatic Disease Trajectories

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.

Study Overview

• Status: Completed
• Conditions: PTSD; Trauma

• Study Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

Study Locations

• Israel
  • Tel-Aviv, Israel
    • Tel-Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: National Institute of Mental Health (NIMH); New York University; Texas A&M University
• Investigators: Principal Investigator: Arieh Y Shalev, Prof., Department of Psychiatry, NYU Langone Medical Center, New York, NY, United States

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2015
• Primary Completion (ACTUAL): March 11, 2020
• Study Completion (ACTUAL): March 11, 2020

Study Registration Dates

• First Submitted: November 25, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (ACTUAL): November 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 0207-14-TLV; R01MH103287 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No