Prevention of PTSD III: Neurocognitive Training of Emotional Regulation

Anxiety Disorders Clinical Trial

Official title:

Prevention of PTSD by Neurocognitive Training of Emotional Regulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085512
• Other study ID #: 14-00879
• Status: Completed
• Phase: N/A
• Start date: March 17, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: August 2018
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder, Major
• Disease
• Major Depression
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Procedure:
• Neurocognitive retraining Web Based Intervention
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.

Other:
• Control, web-based tasks
No training modules

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (3)

Lead Sponsor	Collaborator
New York University School of Medicine	Shaare Zedek Medical Center, Stanford University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amelioration of neurocognitive impairments that are associated with post-traumatic stress disorder	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	Three and nine months after a traumatic event
Secondary	Post-traumatic Stress Disorder (PTSD) symptoms	Decrease in PTSD symptoms from trial's onset	Three and nine months after a traumatic event