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OpenTrials
Completed

NCT Number: NCT02085512

Prevention of PTSD III: Neurocognitive Training of Emotional Regulation

The proposed work will evaluate the ability of neurocognitive retraining of executive functions and emotional regulation to reduce neurocognitive dysfunctions that follow trauma exposure and thereby prevent PTSD. The scientific rationale for this work is the hypothesis that impaired emotional regulation interferes with the expected recovery from the early responses to traumatic events, leading into a chronic disorder. In an initial phase the investigators will recruit 20 recently traumatized participants among trauma survivors admitted to a general hospital emergency room and test the planned intervention's acceptance and right 'dosing'. In the second phase the investigators will enroll 80 recent survivors into a randomized controlled study of the new intervention. The intervention will consist of web-based neurobehavioral training interventions that instill an emotional bias toward positive stimuli, improve emotion recognition and labeling, reduce resistance to emotional distraction, and enhance executive functioning. Control participants will complete web-based video games that do not have emotion-regulatory benefits. Outcome measures will include improvement in neurocognitive functioning and in PTSD symptoms.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaare Zedek Medical Center

Jerusalem, 930031, Israel

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult survivors of traumatic events consecutively admitted to a general hospital Emergency Department

Exclusion criteria

  • Chronic PTSD at the time of the traumatic event. Current and lifetime psychotic or bipolar illness, current substance abuse save alcohol, medical condition precluding participation.

Treatment and study plan

Neurocognitive retraining Web Based Intervention

Procedure

Neurobehavioral training will be delivered through the web, with prompting for training tasks accomplished through daily emails that include a single integrated log-in system using a customized implementation with OneLogin. All training tasks have "game-like" features making them visually engaging, and motivating. The training tasks provide immediate feedback about performance, and are specifically designed to target circuitry critical for executive functioning (EF) and emotional reactivity.

Control, web-based tasks

Other

No training modules

Primary outcomes

  1. Amelioration of neurocognitive impairments that are associated with post-traumatic stress disorder

    Time frame: Three and nine months after a traumatic event

    Impairments in emotional reactivity, emotion regulation, and executive functioning critically contribute to post-trauma psychopathology (including, but not restricted to PTSD). The primary outcome measure of this work are changes (improvements) of these functions at the immediate aftermath of treatment and six months later

Secondary outcomes

  1. Post-traumatic Stress Disorder (PTSD) symptoms

    Time frame: Three and nine months after a traumatic event

    Decrease in PTSD symptoms from trial's onset

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Shaare Zedek Medical Center
  • Stanford University

Registry information

Official study title

Prevention of PTSD by Neurocognitive Training of Emotional Regulation

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 13, 2014
Registry last updated
Aug 31, 2018

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.

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