<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/NCT01694316</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-24890</org_study_id>
    <nct_id>NCT01694316</nct_id>
  </id_info>
  <brief_title>Use of a Novel Neuroplasticity-based Neurobehavioral Intervention for PTSD</brief_title>
  <official_title>Use of a Novel Neuroplasticity-based Neurobehavioral Intervention for PTSD - A Nationwide, Online Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study will explore the effectiveness of a computer based neurobehavioral&#xD;
      intervention in alleviating symptoms and improving emotion regulation in individuals with&#xD;
      PTSD. It will increase understanding of psychopathology at a neural-circuit level and aid&#xD;
      development of new non-pharmacological treatment for PTSD. The study is managed by the Etkin&#xD;
      Lab at Stanford University in California, but participants from the entire US are welcome to&#xD;
      participate as the study is delivered online.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>WebNeuro Computerized Cognitive and Affective Assessment Battery</measure>
    <time_frame>Baseline and 3-month</time_frame>
    <description>Age and gender-normed Z scores for the following measures:&#xD;
Sustained attention accuracy, Sustained attention lapses, Sustained attention false alarms, Working memory capacity, Visual scanning speed, Inhibition executive control, Processing speed, Maze completion executive control accuracy, Maze completion executive control speed, Immediate verbal memory, Delayed verbal memory, Inhibitory motor control accuracy, Inhibitory motor control lapses, Facial affect identification accuracy (happy, fearful, angry, sad, and disgusted), Facial affect identification speed (happy, angry, fearful, sad, or disgusted), Facial affect identity recognition accuracy (happy, angry, sad, fearful, or disgusted), Facial affect identity recognition speed (happy, sad, angry, fearful, or disgusted), Emotional conflict reaction time slowdown, Regulation of emotional conflict reaction time slowdown</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinician-assessed PTSD symptoms</measure>
    <time_frame>Baseline and 3-month</time_frame>
    <description>Total and symptom sub scale scores from the Clinician-Administered PTSD Scale for DSM-IV (CAPS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Engaging in Computerized tasks</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will log into a personalized website and engage in computerized tasks online.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neurobehavioral computerized tasks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will log into a personalized website and engage in computerized tasks online.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computerized Neurobehavioral Intervention</intervention_name>
    <description>Targeted, computerized interventions completed from the participants' own home on a computer.</description>
    <arm_group_label>Engaging in Computerized tasks</arm_group_label>
    <arm_group_label>Neurobehavioral computerized tasks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  current PTSD&#xD;
&#xD;
          -  internet access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lifetime psychotic disorder,&#xD;
&#xD;
          -  past-year substance dependence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanford University, Department of Psychiatry and Behavioral Sciences</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://sites.google.com/site/veteranonlinestudy/</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>August 14, 2018</last_update_submitted>
  <last_update_submitted_qc>August 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Amit Etkin</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Computerized neurobehavioral intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- 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/NCT01694316
org study id: IRB-24890
nct id: NCT01694316
lead sponsor: 
has dmc: No
The present study will explore the effectiveness of a computer based neurobehavioral
      intervention in alleviating symptoms and improving emotion regulation in individuals with
      PTSD. It will increase understanding of psychopathology at a neural-circuit level and aid
      development of new non-pharmacological treatment for PTSD. The study is managed by the Etkin
      Lab at Stanford University in California, but participants from the entire US are welcome to
      participate as the study is delivered online.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: WebNeuro Computerized Cognitive and Affective Assessment Battery
time frame: Baseline and 3-month
description: Age and gender-normed Z scores for the following measures:
Sustained attention accuracy, Sustained attention lapses, Sustained attention false alarms, Working memory capacity, Visual scanning speed, Inhibition executive control, Processing speed, Maze completion executive control accuracy, Maze completion executive control speed, Immediate verbal memory, Delayed verbal memory, Inhibitory motor control accuracy, Inhibitory motor control lapses, Facial affect identification accuracy (happy, fearful, angry, sad, and disgusted), Facial affect identification speed (happy, angry, fearful, sad, or disgusted), Facial affect identity recognition accuracy (happy, angry, sad, fearful, or disgusted), Facial affect identity recognition speed (happy, sad, angry, fearful, or disgusted), Emotional conflict reaction time slowdown, Regulation of emotional conflict reaction time slowdown
measure: Clinician-assessed PTSD symptoms
time frame: Baseline and 3-month
description: Total and symptom sub scale scores from the Clinician-Administered PTSD Scale for DSM-IV (CAPS)
arm group label: Engaging in Computerized tasks
arm group type: Active Comparator
description: Participants will log into a personalized website and engage in computerized tasks online.
arm group label: Neurobehavioral computerized tasks
arm group type: Experimental
description: Participants will log into a personalized website and engage in computerized tasks online.
intervention type: Behavioral
intervention name: Computerized Neurobehavioral Intervention
description: Targeted, computerized interventions completed from the participants' own home on a computer.
arm group label: Engaging in Computerized tasks
arm group label: Neurobehavioral computerized tasks
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
url: https://sites.google.com/site/veteranonlinestudy/
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Amit Etkin
investigator title: Principle Investigator
mesh term: Depression