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Clinical Trials/NCT03756545
NCT03756545
Completed
Not Applicable

Neurobehavioral Moderators of Post-traumatic Disease Trajectories: Prospective MRI Study of Recent Trauma Survivors

Tel-Aviv Sourasky Medical Center1 site in 1 country173 target enrollmentJanuary 20, 2015
ConditionsPTSDTrauma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PTSD
Sponsor
Tel-Aviv Sourasky Medical Center
Enrollment
173
Locations
1
Primary Endpoint
Change in CAPS Total Scores
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 20, 2015
End Date
March 11, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

michal roll

Prof. Talma Hendler

Tel-Aviv Sourasky Medical Center

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)

Outcomes

Primary Outcomes

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).

Study Sites (1)

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