Prevention of PTSD III: Neurocognitive Training of Emotional Regulation

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder; Major Depression; Anxiety Disorders

• Registration Number: NCT02085512
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-13
• Study Start: 2017-03-17
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Amelioration of neurocognitive impairments that are associated with post-traumatic stress disorder	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 Outcome Measures

Name	Time	Method
Post-traumatic Stress Disorder (PTSD) symptoms	Three and nine months after a traumatic event	Decrease in PTSD symptoms from trial's onset

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel