Prevention of PTSD III: Neurocognitive Training of Emotional Regulation

NYU Langone Health

Status: Completed

Conditions: Major Depression; Post Traumatic Stress Disorder; Anxiety Disorders

Treatments: Procedure: Neurocognitive retraining Web Based Intervention; Other: Control, web-based tasks

Study type: Interventional

Funder types: Other

Identifiers

NCT02085512

14-00879

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups, including a placebo group

Neurocognitive retraining

Experimental group

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.

Treatment:

Procedure: Neurocognitive retraining Web Based Intervention

Control, Web Based Tasks

Placebo Comparator group

Description:

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

Treatment:

Other: Control, web-based tasks