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Neurobehavioral Moderators of Post-traumatic Disease Trajectories

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03756545
Enrollment
173
Registered
2018-11-28
Start date
2015-01-20
Completion date
2020-03-11
Last updated
2020-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD, Trauma

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.

Interventions

None listed

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV
New York University
CollaboratorOTHER
Texas A&M University
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in CAPS Total Scoresone-, six- and fourteen months following a traumatic eventThe 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).

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026