Prevention of PTSD III: Neurocognitive Training of Emotional Regulation

Prevention of PTSD by 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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders; Major Depression; Post Traumatic Stress Disorder
• Intervention / Treatment: Procedure: Neurocognitive retraining Web Based Intervention; Other: Control, web-based tasks

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 930031
    • Shaare Zedek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neurocognitive retraining; 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.	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.
Placebo Comparator: Control, Web Based Tasks; Engaging daily, for 30 days in web-based video games or reading tasks that do not specifically engage or train neurocognitive functions.	Other: Control, web-based tasks; No training modules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Stanford University; Shaare Zedek Medical Center
• Investigators: Principal Investigator: Arieh Y Shalev, MD, NYU Langone Medical Center

Publications and helpful links

General Publications

• Fonzo GA, Fine NB, Wright RN, Achituv M, Zaiko YV, Merin O, Shalev AY, Etkin A. Internet-delivered computerized cognitive & affective remediation training for the treatment of acute and chronic posttraumatic stress disorder: Two randomized clinical trials. J Psychiatr Res. 2019 Aug;115:82-89. doi: 10.1016/j.jpsychires.2019.05.007. Epub 2019 May 8.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: March 11, 2014
• First Submitted That Met QC Criteria: March 12, 2014
• First Posted (Estimate): March 13, 2014

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Major Depression; Secondary Prevention; Post Traumatic Stress Disorder (PTSD); Neurocognitive Retraining
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Trauma and Stressor Related Disorders; Depressive Disorder; Depression; Disease; Anxiety Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Depressive Disorder, Major
• Other Study ID Numbers: 14-00879

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No