Prevention of PTSD III: Neurocognitive Training of Emotional Regulation

NCT02085512 | Completed DMC

• 1 other identifier: 14-00879
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder; Major Depression; Anxiety Disorders

Keywords

Post Traumatic Stress Disorder (PTSD); Major Depression; Secondary Prevention; Neurocognitive Retraining; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-traumatic Stress Disorder (PTSD) symptoms

  Three and nine months after a traumatic event

Study Arms (2)

Neurocognitive retraining

EXPERIMENTAL

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

Control, Web Based Tasks

PLACEBO COMPARATOR

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

Interventions

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.

Neurocognitive retraining

Control, web-based tasks OTHER

No training modules

Control, Web Based Tasks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Stanford University: collaborator
• Shaare Zedek Medical Center: collaborator

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 930031, Israel

Location

Related Publications (1)

• 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.

  PMID: 31125916 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depressive Disorder, Major; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Study Officials

• Arieh Y Shalev, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 13, 2014
• Study Start: March 17, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

IL (1)