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Prevention of Post Traumatic Stress Disorder Following Trauma by Attention Control Training

This study is currently recruiting participants.
Verified April 2017 by Yair Bar-Haim, Tel Aviv University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02591485
First Posted: October 29, 2015
Last Update Posted: April 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yair Bar-Haim, Tel Aviv University
  Purpose

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 Intervention
PTSD Behavioral: Attention Control Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Post Traumatic Stress Disorder Following Trauma by Attention Control Training

Resource links provided by NLM:


Further study details as provided by Yair Bar-Haim, Tel Aviv University:

Primary Outcome Measures:
  • 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).


Other Outcome Measures:
  • 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).


Estimated Enrollment: 100
Study Start Date: February 2016
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The occurrence of a traumatic event (criteria A of PTSD from the DSM-5) in the period of less than a month from the beginning of the study.
  2. An ASD diagnosis (score 14 and above in the ASDI).

Exclusion Criteria:

  1. A previous traumatic event in the period of three month or less before the current event.
  2. Chronic PTSD.
  3. A diagnosis of psychotic or bipolar disorders.
  4. A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
  5. Suicidal ideation.
  6. Drugs or alcohol abuse.
  7. Another psychotherapeutic treatment.
  8. A pharmacological treatment that is not stabilized in the past 6 months (A stable pharmacological treatment will not be a reason for exclusion from the study).
  9. Poor judgment capacity (i.e., special populations).
  10. Pregnant women.

Within Study exclusion criteria:

  1. Change in medication status or beginning a psychotherapeutic treatment during the study.
  2. Disagreement to participate in the study.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Yair Bar-Haim, Prof. yair1@post.tau.ac.il
Contact: Adva Segal advasegal@post.tau.ac.il

Locations
Israel
Tel-Aviv University Recruiting
Tel-Aviv, Israel
Contact: Yair Bar-Haim, Prof.       yair1@post.tau.ac.il   
Contact: Adva Segal       advasegal@post.tau.ac.il   
Sponsors and Collaborators
Yair Bar-Haim
Investigators
Study Director: Yair Bar-Haim, Prof. Tel Aviv University
  More Information

Publications:
Weathers, F., Blake, D., Schnurr, P., Kaloupek, D., Marx, B., & Keane, T., The clinician-administered PTSD scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at www. ptsd. va. gov, 2013.
Weathers, F., B. Litz, T. Keane, P. Palmieri, B. Marx, & P. Schnurr, The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www. ptsd. va. gov, 2013.
American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-5). 2013: American Psychiatric Pub.
Harvey AG, Bryant RA. The relationship between acute stress disorder and posttraumatic stress disorder: a prospective evaluation of motor vehicle accident survivors. J Consult Clin Psychol. 1998 Jun;66(3):507-12.
Iacoviello BM, Wu G, Abend R, Murrough JW, Feder A, Fruchter E, Levinstein Y, Wald I, Bailey CR, Pine DS, Neumeister A, Bar-Haim Y, Charney DS. Attention bias variability and symptoms of posttraumatic stress disorder. J Trauma Stress. 2014 Apr;27(2):232-239. doi: 10.1002/jts.21899. Epub 2014 Mar 6.
Badura-Brack AS, Naim R, Ryan TJ, Levy O, Abend R, Khanna MM, McDermott TJ, Pine DS, Bar-Haim Y. Effect of Attention Training on Attention Bias Variability and PTSD Symptoms: Randomized Controlled Trials in Israeli and U.S. Combat Veterans. Am J Psychiatry. 2015 Dec;172(12):1233-41. doi: 10.1176/appi.ajp.2015.14121578. Epub 2015 Jul 24.
Naim R, Abend R, Wald I, Eldar S, Levi O, Fruchter E, Ginat K, Halpern P, Sipos ML, Adler AB, Bliese PD, Quartana PJ, Pine DS, Bar-Haim Y. Threat-Related Attention Bias Variability and Posttraumatic Stress. Am J Psychiatry. 2015 Dec;172(12):1242-50. doi: 10.1176/appi.ajp.2015.14121579. Epub 2015 Jul 24.
Bryant, R. A., Harvey, A., G., Dang, S., T., & Sackville, T., Assessing acute stress disorder: Psychometric properties of a structured clinical interview. Psychological Assessment, 1998. 10(3): p. 215.

Responsible Party: Yair Bar-Haim, Professor Yair Bar-Haim, Tel Aviv University
ClinicalTrials.gov Identifier: NCT02591485     History of Changes
Other Study ID Numbers: TASMC - 15 - PH - 0409 - CTIL
First Submitted: October 28, 2015
First Posted: October 29, 2015
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yair Bar-Haim, Tel Aviv University:
PTSD prevention
Acute stress disorder
Attention training
Cognitive bias modification

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders


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