<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01723215</url>
  </required_header>
  <id_info>
    <org_study_id>TelAvivU</org_study_id>
    <nct_id>NCT01723215</nct_id>
  </id_info>
  <brief_title>Prevention of Combat-related PTSD Using Attention Bias Modification (ABM): A Randomized Controlled Trial</brief_title>
  <official_title>Prevention of Posttraumatic Symptoms in IDF Soldiers Using Attention Bias Modification (ABM): A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel Aviv University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Corps, Israel Defense Force</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Walter Reed Army Institute of Research (WRAIR)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Tel Aviv University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Military deployment to combat zones involves exposure to trauma at a higher than average rate&#xD;
      and therefore presents a unique opportunity to study predisposing factors to posttraumatic&#xD;
      stress reactions and test strategies designed to prevent and ameliorate posttraumatic&#xD;
      symptoms. Decades of scientific research on the origins of resilience and vulnerability to&#xD;
      combat-related posttraumatic stress symptoms revealed various predisposing and protective&#xD;
      factors. All these factors however, offer limited opportunity for systematic pre-deployment&#xD;
      prevention efforts. Considering the magnitude of psychological adjustment difficulties&#xD;
      encountered by combat personnel in deployment and the limited access to existing&#xD;
      evidence-based therapies for PTSD, the development and testing of a novel evidence-based and&#xD;
      theory-driven prevention protocol for these problems is of considerable significance. The&#xD;
      current study translates cognitive-neuroscience knowledge and attention bias modification&#xD;
      research into a novel computerized training tool that could be easily delivered to soldiers&#xD;
      during different stages of the deployment cycle. If proved efficacious in reducing risk for&#xD;
      posttraumatic symptoms ABMT could be integrated into the Army's resilience training program.&#xD;
      Thus, we propose a longitudinal double-blind randomized controlled study of ABMT in soldiers.&#xD;
      We will assess attention bias and symptoms before deployment, will randomly assign soldiers&#xD;
      to either 8 ABMT sessions, 4 ABMT sessions, 8 Placebo training sessions, or no training.&#xD;
      Following 6 months of deployment to combat zone symptoms will be assessed again.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in PTSD symptoms(PCL)</measure>
    <time_frame>Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat</time_frame>
    <description>1. pre-treatment 2.after first deployment 3.10 days after combat 4. 4 months after combat</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Probable PTSD diagnosis(CAPS)</measure>
    <time_frame>Four months after combat</time_frame>
    <description>Four months after combat</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Depression(PHQ-9)) and Anxiety(STAI)</measure>
    <time_frame>Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat</time_frame>
    <description>1. Pre-treatment(baseline) 2.after first deployment 3.10 days after combat 4. 4 months after combat</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Attention Bias Scores</measure>
    <time_frame>Pre-traetment baseline and in deployment</time_frame>
    <description>Attention bias scores measured in milliseconds using the dot-probe task</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">862</enrollment>
  <condition>PTSD</condition>
  <arm_group>
    <arm_group_label>Active ABMT8</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active ABMT8 8 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active ABMT4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active ABMT4 4 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control: will not receive any intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo: will receive 4 training sessions(10 min. each, over 7-8 weeks) using the same task and stimuli as in the active arms, but not designed to change attention patterns</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active ABMT8</intervention_name>
    <description>Active ABMT8 8 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance</description>
    <arm_group_label>Active ABMT8</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active ABMT4</intervention_name>
    <description>Active ABMT4 4 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance</description>
    <arm_group_label>Active ABMT4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo: will receive 4 training sessions(10 min. each, over 7-8 weeks) using the same task and stimuli as in the active arms, but not designed to change attention patterns</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  combat soldiers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fluent Hebrew&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>28 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yair Bar-Haim, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tel Aviv University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eyal Fruchter</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mental Health Department IDF</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IDF Military camps</name>
      <address>
        <city>Beer sheva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Bar-Haim Y. Research review: Attention bias modification (ABM): a novel treatment for anxiety disorders. J Child Psychol Psychiatry. 2010 Aug;51(8):859-70. doi: 10.1111/j.1469-7610.2010.02251.x. Epub 2010 May 6.</citation>
    <PMID>20456540</PMID>
  </reference>
  <reference>
    <citation>Bar-Haim Y, Holoshitz Y, Eldar S, Frenkel TI, Muller D, Charney DS, Pine DS, Fox NA, Wald I. Life-threatening danger and suppression of attention bias to threat. Am J Psychiatry. 2010 Jun;167(6):694-8. doi: 10.1176/appi.ajp.2009.09070956. Epub 2010 Apr 15.</citation>
    <PMID>20395400</PMID>
  </reference>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>March 17, 2015</last_update_submitted>
  <last_update_submitted_qc>March 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tel Aviv University</investigator_affiliation>
    <investigator_full_name>Yair Bar-Haim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Attention bias modification</keyword>
  <keyword>resilience</keyword>
  <keyword>combat</keyword>
  <keyword>PTSD</keyword>
  <keyword>Depression</keyword>
  <keyword>Anxiety</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01723215
org study id: TelAvivU
nct id: NCT01723215
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Military deployment to combat zones involves exposure to trauma at a higher than average rate
      and therefore presents a unique opportunity to study predisposing factors to posttraumatic
      stress reactions and test strategies designed to prevent and ameliorate posttraumatic
      symptoms. Decades of scientific research on the origins of resilience and vulnerability to
      combat-related posttraumatic stress symptoms revealed various predisposing and protective
      factors. All these factors however, offer limited opportunity for systematic pre-deployment
      prevention efforts. Considering the magnitude of psychological adjustment difficulties
      encountered by combat personnel in deployment and the limited access to existing
      evidence-based therapies for PTSD, the development and testing of a novel evidence-based and
      theory-driven prevention protocol for these problems is of considerable significance. The
      current study translates cognitive-neuroscience knowledge and attention bias modification
      research into a novel computerized training tool that could be easily delivered to soldiers
      during different stages of the deployment cycle. If proved efficacious in reducing risk for
      posttraumatic symptoms ABMT could be integrated into the Army's resilience training program.
      Thus, we propose a longitudinal double-blind randomized controlled study of ABMT in soldiers.
      We will assess attention bias and symptoms before deployment, will randomly assign soldiers
      to either 8 ABMT sessions, 4 ABMT sessions, 8 Placebo training sessions, or no training.
      Following 6 months of deployment to combat zone symptoms will be assessed again.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Changes in PTSD symptoms(PCL)
time frame: Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat
description: 1. pre-treatment 2.after first deployment 3.10 days after combat 4. 4 months after combat
measure: Probable PTSD diagnosis(CAPS)
time frame: Four months after combat
description: Four months after combat
measure: Changes in Depression(PHQ-9)) and Anxiety(STAI)
time frame: Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat
description: 1. Pre-treatment(baseline) 2.after first deployment 3.10 days after combat 4. 4 months after combat
measure: Attention Bias Scores
time frame: Pre-traetment baseline and in deployment
description: Attention bias scores measured in milliseconds using the dot-probe task
arm group label: Active ABMT8
arm group type: Active Comparator
description: Active ABMT8 8 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance
arm group label: Active ABMT4
arm group type: Active Comparator
description: Active ABMT4 4 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance
arm group label: Control
arm group type: No Intervention
description: Control: will not receive any intervention
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo: will receive 4 training sessions(10 min. each, over 7-8 weeks) using the same task and stimuli as in the active arms, but not designed to change attention patterns
intervention type: Behavioral
intervention name: Active ABMT8
description: Active ABMT8 8 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance
arm group label: Active ABMT8
intervention type: Behavioral
intervention name: Active ABMT4
description: Active ABMT4 4 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance
arm group label: Active ABMT4
intervention type: Behavioral
intervention name: Placebo
description: Placebo: will receive 4 training sessions(10 min. each, over 7-8 weeks) using the same task and stimuli as in the active arms, but not designed to change attention patterns
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 28 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yair Bar-Haim, PhD
role: Principal Investigator
affiliation: Tel Aviv University
last name: Eyal Fruchter
role: Principal Investigator
affiliation: Mental Health Department IDF
facility: 
country: Israel
citation: Bar-Haim Y. Research review: Attention bias modification (ABM): a novel treatment for anxiety disorders. J Child Psychol Psychiatry. 2010 Aug;51(8):859-70. doi: 10.1111/j.1469-7610.2010.02251.x. Epub 2010 May 6.
PMID: 20456540
citation: Bar-Haim Y, Holoshitz Y, Eldar S, Frenkel TI, Muller D, Charney DS, Pine DS, Fox NA, Wald I. Life-threatening danger and suppression of attention bias to threat. Am J Psychiatry. 2010 Jun;167(6):694-8. doi: 10.1176/appi.ajp.2009.09070956. Epub 2010 Apr 15.
PMID: 20395400
responsible party type: Principal Investigator
investigator affiliation: Tel Aviv University
investigator full name: Yair Bar-Haim
investigator title: Professor