<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/NCT01694303</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-24519</org_study_id>
    <nct_id>NCT01694303</nct_id>
  </id_info>
  <brief_title>Computerized Interventions for College Students' Cognitive Functioning and Mental Well-being</brief_title>
  <official_title>Computerized Interventions for College Students' Cognitive Functioning and Mental Well-being</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 improving cognition and emotion regulation in a college freshmen population.&#xD;
      It will increase understanding of emotion-regulation and cognition at a neural-circuit level&#xD;
      and aid development of new interventions for emotion regulatory problems.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Emotion-regulation - behavioral and fMRI</measure>
    <time_frame>3-month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognition - executive function behavioral reaction time</measure>
    <time_frame>3-month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Engaging 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 computerized tasks</arm_group_label>
    <arm_group_label>Neurobehavioral computerized tasks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#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>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anett Gyurak, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University, Department of Psychiatry and Behavioral Sciences</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</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>July 15, 2015</last_update_submitted>
  <last_update_submitted_qc>July 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2015</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>
  <!-- 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/NCT01694303
org study id: IRB-24519
nct id: NCT01694303
lead sponsor: 
has dmc: No
The present study will explore the effectiveness of a computer based neurobehavioral
      intervention in improving cognition and emotion regulation in a college freshmen population.
      It will increase understanding of emotion-regulation and cognition at a neural-circuit level
      and aid development of new interventions for emotion regulatory problems.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Emotion-regulation - behavioral and fMRI
time frame: 3-month
measure: Cognition - executive function behavioral reaction time
time frame: 3-month
arm group label: Engaging 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 computerized tasks
arm group label: Neurobehavioral computerized tasks
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anett Gyurak, PhD
role: Study Director
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Amit Etkin
investigator title: Principle Investigator