Clinical trial NCT02085512: Prevention of PTSD III: Neurocognitive Training of Emotional Regulation
Official title: Prevention of PTSD by Neurocognitive Training of Emotional Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Major Depression
Anxiety Disorders
Keywords: Post Traumatic Stress Disorder (PTSD)
Major Depression
Secondary Prevention
Neurocognitive Retraining
Randomized Controlled Trial
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Shaare Zedek Medical Center
First posted: 2014-03-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Amelioration of neurocognitive impairments that are associated with post-traumatic stress disorder
timeFrame: Three and nine months after a traumatic event
Secondary outcomes:
measure: Post-traumatic Stress Disorder (PTSD) symptoms
timeFrame: Three and nine months after a traumatic event
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: NYU Langone Medical Center
name: Arieh Y Shalev, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.