Anxiety Disorders, Major Depression, Post Traumatic Stress Disorder
Conditions
Keywords
Post Traumatic Stress Disorder (PTSD), Major Depression, Secondary Prevention, Neurocognitive Retraining, Randomized Controlled Trial
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.
Interventions
PROCEDURENeurocognitive 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.
OTHERControl, web-based tasks
No training modules
Sponsors
Stanford University
Shaare Zedek Medical Center
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amelioration of neurocognitive impairments that are associated with post-traumatic stress disorder | Three and nine months after a traumatic event | 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
| Measure | Time frame | Description |
|---|---|---|
| Post-traumatic Stress Disorder (PTSD) symptoms | Three and nine months after a traumatic event | Decrease in PTSD symptoms from trial's onset |
Countries
Israel
Outcome results
None listed