Prevention of PTSD III: Neurocognitive Training of Emotional Regulation
NCT02085512 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2018-08-31
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
Interventions
- 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
Sponsors & Collaborators
- collaborator OTHER
-
Shaare Zedek Medical Center
collaborator OTHER - lead OTHER
Principal Investigators
-
Arieh Y Shalev, MD · NYU Langone Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-17
- Primary Completion
- 2017-12-31
- Completion
- 2017-12-31
Countries
- Israel
Study Locations
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