Prevention of Post Traumatic Stress Disorder Following Trauma by Attention Control Training
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|ClinicalTrials.gov Identifier: NCT02591485|
Recruitment Status : Recruiting
First Posted : October 29, 2015
Last Update Posted : April 11, 2017
The purpose of this study is to explore the efficacy of Attention Control Training in preventing the development of Post Traumatic Stress Disorder (PTSD), during the period near after a traumatic event and before PTSD is develop.
Individuals who underwent a traumatic event in the past two weeks will be randomly assigned to either Attention Control Training (ACT), designed to normalize threat-related attention biases or a control conditions: a psych-education intervention, designed as an active placebo condition or a follow-up condition, without intervention at all.
Outcome measures will be a diagnosed of PTSD and the level of severity of symptoms derived from the Clinician Administered PTSD Scale (CAPS-5), after 3 and 6 month since the traumatic event had occurred.
The investigators expected to find lower ratios of PTSD symptoms in the ACT condition relative to the control conditions in which no symptomatic relief is expected.
|Condition or disease||Intervention/treatment|
|PTSD||Behavioral: Attention Control Training|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Post Traumatic Stress Disorder Following Trauma by Attention Control Training|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||January 2019|
Experimental: Attention Control Training
Computerized attention modification training, comprised of six sessions that delivered by internet, in purpose of modulate biases in attention for threat stimuli.
Behavioral: Attention Control Training
In the ACT, participants perform six computerized attention training sessions, 10 minutes per training session over six weeks. In each session the dot-probe task is administered. This task is consisted of 160 trials. Each trial began with a centrally-presented fixation cross that then replaced by a pair of words presented. Following that, a target probe appeared in the location previously occupied by one of the words, and participants are requested to discriminate the probe type via button press. Targets appear with equal probability at the location of threat and neutral stimuli, in order to modify the fluctuations in attention allocation.
No Intervention: Follow-up only
In this condition, a follow up interviews will be conducted 3 and 6 months since the traumatic event had occurred.
- A diagnosis of PTSD and a total score of severity symptoms, as driven from the CAPS-5 interview. [ Time Frame: 40 minutes ]The Clinician Administered PTSD Scale (CAPS-5), is a structured interview that will be used to make a diagnosis of PTSD according to the DSM-V criteria. This interview is consists of 30 items regarding the frequency and intensity of PTSD symptoms and a total score of severity is been rated (Weathers, Blake, Schnurr, Kaloupek, Marx, & Keane, 2013).
- Total score of the PTSD Checklist (PCL-5). [ Time Frame: 10 minutes ]The PCL-5, is a 20-item National Center for PTSD Checklist of the Department of Veterans Affairs. Scores can range from 0 to 80, with higher scores reflecting more symptoms of PTSD (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591485
|Contact: Yair Bar-Haim, Prof. email@example.com|
|Contact: Adva Segal firstname.lastname@example.org|
|Study Director:||Yair Bar-Haim, Prof.||Tel Aviv University|