Neurobehavioral Moderators of Post-traumatic Disease Trajectories

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.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Collaborators

National Institute of Mental Health (NIMH)
New York University
Texas A&M University

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2020
Study completion: 2020
First posted: Nov 28, 2018
Registry last updated: Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed