Neurobehavioral Moderators of Post-traumatic Disease Trajectories

NCT ID: NCT03756545

Last Updated: 2020-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

173 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-20

Study Completion Date

2020-03-11

Brief Summary

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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.

Detailed Description

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Conditions

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PTSD Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York University

OTHER

Sponsor Role collaborator

Texas A&M University

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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michal roll

Prof. Talma Hendler

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arieh Y Shalev, Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 36628514 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34098066 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31973980 (View on PubMed)

Other Identifiers

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R01MH103287

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0207-14-TLV

Identifier Type: -

Identifier Source: org_study_id

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