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Prevention of PTSD III: Neurocognitive Training of Emotional Regulation

Primary Purpose

Post Traumatic Stress Disorder, Major Depression, Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Neurocognitive retraining Web Based Intervention
Control, web-based tasks
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Traumatic Stress Disorder focused on measuring Post Traumatic Stress Disorder (PTSD), Major Depression, Secondary Prevention, Neurocognitive Retraining, Randomized Controlled Trial

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shaare Zedek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Neurocognitive retraining

Control, Web Based Tasks

Arm Description

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.

Engaging daily, for 30 days in web-based video games or reading tasks that do not specifically engage or train neurocognitive functions.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Post-traumatic Stress Disorder (PTSD) symptoms
Decrease in PTSD symptoms from trial's onset

Full Information

First Posted
March 11, 2014
Last Updated
August 29, 2018
Sponsor
NYU Langone Health
Collaborators
Stanford University, Shaare Zedek Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02085512
Brief Title
Prevention of PTSD III: Neurocognitive Training of Emotional Regulation
Official Title
Prevention of PTSD by Neurocognitive Training of Emotional Regulation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 17, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Stanford University, Shaare Zedek Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Major Depression, Anxiety Disorders
Keywords
Post Traumatic Stress Disorder (PTSD), Major Depression, Secondary Prevention, Neurocognitive Retraining, Randomized Controlled Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurocognitive retraining
Arm Type
Experimental
Arm Description
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.
Arm Title
Control, Web Based Tasks
Arm Type
Placebo Comparator
Arm Description
Engaging daily, for 30 days in web-based video games or reading tasks that do not specifically engage or train neurocognitive functions.
Intervention Type
Procedure
Intervention Name(s)
Neurocognitive retraining Web Based Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control, web-based tasks
Intervention Description
No training modules
Primary Outcome Measure Information:
Title
Amelioration of neurocognitive impairments that are associated with post-traumatic stress disorder
Description
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
Time Frame
Three and nine months after a traumatic event
Secondary Outcome Measure Information:
Title
Post-traumatic Stress Disorder (PTSD) symptoms
Description
Decrease in PTSD symptoms from trial's onset
Time Frame
Three and nine months after a traumatic event

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arieh Y Shalev, MD
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
930031
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
31125916
Citation
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.
Results Reference
derived

Learn more about this trial

Prevention of PTSD III: Neurocognitive Training of Emotional Regulation

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