Prevention of PTSD III: Neurocognitive Training of Emotional Regulation

Study Overview
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Brief Summary
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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.

Official Title
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Prevention of PTSD by Neurocognitive Training of Emotional Regulation

Conditions
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Post Traumatic Stress Disorder, Major Depression, Anxiety Disorders

Intervention / Treatment
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* Procedure: Neurocognitive retraining Web Based Intervention
* Other: Control, web-based tasks


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurocognitive retraining<br>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<br>* 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.<br>|
| Placebo Comparator: Control, Web Based Tasks<br>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<br>* No training modules<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Traumatic Stress Disorder (PTSD), Major Depression, Secondary Prevention, Neurocognitive Retraining, Randomized Controlled Trial