Clinical trial NCT03756545: Neurobehavioral Moderators of Post-traumatic Disease Trajectories
Official title: Neurobehavioral Moderators of Post-traumatic Disease Trajectories: Prospective MRI Study of Recent Trauma Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PTSD
Trauma
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: New York University
name: Texas A&M University
name: National Institute of Mental Health (NIMH)
First posted: 2018-11-28
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in CAPS Total Scores
timeFrame: one-, six- and fourteen months following a traumatic event
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Department of Psychiatry, NYU Langone Medical Center, New York, NY, United States
name: Arieh Y Shalev, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.