<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/NCT03280472</url>
  </required_header>
  <id_info>
    <org_study_id>01368r</org_study_id>
    <nct_id>NCT03280472</nct_id>
  </id_info>
  <brief_title>Transition to College/Miami University</brief_title>
  <official_title>Transition to College/Miami University</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Miami University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Miami University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current project will test whether a computerized training program, Cognitive Bias&#xD;
      Modification (CBM), can be used as a prevention inoculation tool to reduce vulnerability to&#xD;
      anxiety among incoming college students. Those not in the CBM condition will complete a&#xD;
      symptom tracking condition (ST). We will also test whether ST influences vulnerability to&#xD;
      anxiety among incoming college students.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Student Adjustment to College Questionnaire</measure>
    <time_frame>Participants report on their past few days. The SACQ is administered at T1-T5. T2 occurs within ~1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.</time_frame>
    <description>Self-report on the degree to which the participant feels they are transitioning to college successfully.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Interpretations</measure>
    <time_frame>Participants report interpretations to a variety of situations. The IQ is administered at T1 and T4. T2 occurs within 1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.</time_frame>
    <description>A questionnaire assessing their interpretation of ambiguous, potentially anxiety-provoking situation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Liebowitz Social Anxiety Scale-Self-Report</measure>
    <time_frame>Participants report on symptoms during the past week. The LSAS-SR is administered at T1-T5. T2 occurs within ~1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.</time_frame>
    <description>Self-report of social anxiety symptoms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Interpretation Bias Modification</condition>
  <condition>Symptom Tracking</condition>
  <arm_group>
    <arm_group_label>Cognitive Bias Modification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete three session of cognitive bias modification.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Symptom Tracking</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will track their symptoms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Bias Modification</intervention_name>
    <description>CBM training. For those in the CBM condition, participants will complete a task. In this task, they will read ambiguous, two- to four-sentence social-related scenarios on the computer. The final word in the scenario will have a missing letter. Participants will type the missing letter. Participants will also be asked to answer a &quot;Yes/No&quot; comprehension question about the scenario. The missing letter will &quot;resolve&quot; the ambiguity of the scenario in a positive way, intended to train participants to have more positively-biased interpretations of ambiguous social information</description>
    <arm_group_label>Cognitive Bias Modification</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Symptom tracking</intervention_name>
    <description>Participants will track their symptoms</description>
    <arm_group_label>Symptom Tracking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First and Second year students&#xD;
&#xD;
          -  Entered college in fall of 2017&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
          -  LSAS-SR score greater than or equal to 14 and less than or equal to 74.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elise Clerkin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Miami University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elise M Clerkin, PhD</last_name>
    <phone>513-529-2483</phone>
    <email>clerkiem@miamioh.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Anxiety Cognition and Emotion Laboratory</name>
      <address>
        <city>Oxford</city>
        <state>Ohio</state>
        <zip>45056</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elise M Clerkin, PhD</last_name>
      <phone>513-529-2483</phone>
      <email>cleriem@miamioh.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>December 16, 2017</last_update_submitted>
  <last_update_submitted_qc>December 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Miami University</investigator_affiliation>
    <investigator_full_name>Elise Clerkin</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Interpretation Bias</keyword>
  <keyword>Interpretation Modification Program</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03280472
org study id: 01368r
nct id: NCT03280472
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current project will test whether a computerized training program, Cognitive Bias
      Modification (CBM), can be used as a prevention inoculation tool to reduce vulnerability to
      anxiety among incoming college students. Those not in the CBM condition will complete a
      symptom tracking condition (ST). We will also test whether ST influences vulnerability to
      anxiety among incoming college students.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Student Adjustment to College Questionnaire
time frame: Participants report on their past few days. The SACQ is administered at T1-T5. T2 occurs within ~1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.
description: Self-report on the degree to which the participant feels they are transitioning to college successfully.
measure: Change in Interpretations
time frame: Participants report interpretations to a variety of situations. The IQ is administered at T1 and T4. T2 occurs within 1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.
description: A questionnaire assessing their interpretation of ambiguous, potentially anxiety-provoking situation
measure: Change in Liebowitz Social Anxiety Scale-Self-Report
time frame: Participants report on symptoms during the past week. The LSAS-SR is administered at T1-T5. T2 occurs within ~1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.
description: Self-report of social anxiety symptoms
arm group label: Cognitive Bias Modification
arm group type: Experimental
description: Participants will complete three session of cognitive bias modification.
arm group label: Symptom Tracking
arm group type: Other
description: Participants will track their symptoms.
intervention type: Behavioral
intervention name: Cognitive Bias Modification
description: CBM training. For those in the CBM condition, participants will complete a task. In this task, they will read ambiguous, two- to four-sentence social-related scenarios on the computer. The final word in the scenario will have a missing letter. Participants will type the missing letter. Participants will also be asked to answer a "Yes/No" comprehension question about the scenario. The missing letter will "resolve" the ambiguity of the scenario in a positive way, intended to train participants to have more positively-biased interpretations of ambiguous social information
arm group label: Cognitive Bias Modification
intervention type: Behavioral
intervention name: Symptom tracking
description: Participants will track their symptoms
arm group label: Symptom Tracking
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elise Clerkin, PhD
role: Principal Investigator
affiliation: Miami University
last name: Elise M Clerkin, PhD
phone: 513-529-2483
email: clerkiem@miamioh.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Miami University
investigator full name: Elise Clerkin
investigator title: Assistant Professor
sharing ipd: No