Resilience Among Trauma Survivors

NCT06484803 | Enrolling By Invitation

• 1 other identifier: 0918-20-TLV
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

A major gap remains in understanding the neurobehavioral mechanism of individuals' variability in the dynamic process of responding to traumatic events. To address this gap, the proposed study is focused on two dominant survival processes: acute stress response and motivational behavior. Investigating the involvement of these processes in long-term recovery from a documented traumatic event, our study extends a prior longitudinal investigation in our lab that systematically assessed the neurobehavioral factors contributing to the development of PTSD.

Conditions

PTSD

Keywords

Trauma

Outcome Measures

Primary Outcomes (4)

• PTSD Clinical trajectories

  Change in PTSD symptoms measured by change in Clinician-Administered PTSD Scale. The Clinician-Administered PTSD Scale is used to assess PTSD diagnostic status and symptom severity. We use both CAPS-V (according to DSM-4) and CAPS-5 (according to DSM-5) at 4 time points after exposure (1mo, 6mo, 14mo, \~60mo).

  Approximately 6 years

• Change in PTSD symptoms following the October 7th, 2023 events

  Measured by the PTSD Checklist (PCL-5), a self-report measure (20 items) assessing the severity of PTSD symptoms, reflecting the diagnostic criteria of DSM-5. The PCL-5 total score can range from 0-80; with higher scores reflecting greater severity.

  Half an hour

• Change in anxiety symptoms following the October 7th, 2023 events

  Measured by the Beck Anxiety Inventory (BAI), a self-reported measure (21 items) of concurrent anxiety symptoms.

  Half an hour

• Change in depressive symptoms following the October 7th, 2023 events

  Measured by the Beck Depression Inventory (BDI), a self-reported measure (21 items) of depression symptoms and intensity, which was proven to be a good predictor of chronic PTSD at one week and one month after trauma.

  Half an hour

Secondary Outcomes (3)

• Neural response to acute stress induction and PTSD resilience

  4 hours

• Neural measures of reward and punishment and PTSD resilience

  4 hours

• Neurobehavioral Measures of Approach-Avoidance Conflict Related to PTSD Resilience

  4 hours

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult civilians admitted to Tel-Aviv Sourasky Medical Center's Emergency Room (ER), following a potentially traumatic incident.

You may qualify if:

• Participated in the initial study after an exposure to a traumatic event.
• Age:18 - 70 years.
• Able to read and comprehend Hebrew.

You may not qualify if:

• Individuals who can't perform an MRI due to safety reasons (e.g. irremovable metals in their body) or claustrophobia.
• Individuals with a diagnosis of substance abuse, psychotic or bipolar I disorder.
• Individuals with documented head trauma with coma exceeding 30 minutes or with known neurological deficit.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Tel Aviv University: collaborator

Study Sites (1)

Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: October 14, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

IL (1)