<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/NCT04500340</url>
  </required_header>
  <id_info>
    <org_study_id>UGrantsCommission</org_study_id>
    <nct_id>NCT04500340</nct_id>
  </id_info>
  <brief_title>Effectiveness of Cognitive Behavioral Therapy of Reduction of Test Anxiety</brief_title>
  <acronym>GroupCBT</acronym>
  <official_title>Test Anxiety: Pervasiveness, Link With Academic Achievement and Impact of Cognitive-behavioral Intervention in Its Reduction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Grants Commission</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Grants Commission</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>
      This study will evaluate the role of Group Cognitive Behavioral Therapy in test anxiety. The&#xD;
      study participants will be psychology undergraduates with social work and psychology majors.&#xD;
      The students will be selected among those who score three or more in Westside Test Anxiety&#xD;
      Scale will participate in the study. Westside Test Anxiety will be used two weeks after&#xD;
      completion of the group Cognitive Behavioral Therapy protocol (Flaxman, Bond &amp; Keogh. 2004).&#xD;
      The result will be analyzed using the t-test and Cohen's d.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 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>Westside Test Anxiety Scale (WTAS)</measure>
    <time_frame>Change from Baseline Test Anxiety Scores after completion of Group Cognitive Behavioral Therapy ( after one and half month)</time_frame>
    <description>The WTAS consists of 10 items, each using a Likert response scale where 1= &quot;Never true&quot; and 5= &quot;always true. Total score is divided by 10 to obtain final scores. The total score ranges from one to five. Score of 1-2.9 is considered normal test anxiety and score of 3-5 is labelled as high test anxiety.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Test Anxiety</condition>
  <arm_group>
    <arm_group_label>Group Cognitive Behavioral Therapy (Group CBT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention Group will receive ten-session group CBT for test anxiety. Two sessions will be carried out each week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The Control group will be waiting for the control group who will receive intervention if they demand after final assessment for outcome measure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group CBT for test anxiety</intervention_name>
    <description>The cognitive-behavioral therapy protocol developed by Flaxman, Bond &amp; Keogh (2004) will be used as the intervention protocol. This protocol consists of 10 Sessions which are provided twice a week (each group will have 10 students).</description>
    <arm_group_label>Group Cognitive Behavioral Therapy (Group CBT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Those Studying Social work and Psychology as Major subjects, Those who have scored 3&#xD;
             and above in Westside Test Anxiety scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those scoring below 3 in Westside Test Anxiety Scale&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Khem R. Bhatta, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tribhuvan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nepal Mega College and K and K International College</name>
      <address>
        <city>Kathmandu</city>
        <state>Bagmati</state>
        <country>Nepal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nepal</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Grants Commission</investigator_affiliation>
    <investigator_full_name>Khem Raj Bhatta</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</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/NCT04500340
org study id: UGrantsCommission
nct id: NCT04500340
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the role of Group Cognitive Behavioral Therapy in test anxiety. The
      study participants will be psychology undergraduates with social work and psychology majors.
      The students will be selected among those who score three or more in Westside Test Anxiety
      Scale will participate in the study. Westside Test Anxiety will be used two weeks after
      completion of the group Cognitive Behavioral Therapy protocol (Flaxman, Bond & Keogh. 2004).
      The result will be analyzed using the t-test and Cohen's d.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Westside Test Anxiety Scale (WTAS)
time frame: Change from Baseline Test Anxiety Scores after completion of Group Cognitive Behavioral Therapy ( after one and half month)
description: The WTAS consists of 10 items, each using a Likert response scale where 1= "Never true" and 5= "always true. Total score is divided by 10 to obtain final scores. The total score ranges from one to five. Score of 1-2.9 is considered normal test anxiety and score of 3-5 is labelled as high test anxiety.
arm group label: Group Cognitive Behavioral Therapy (Group CBT)
arm group type: Experimental
description: Intervention Group will receive ten-session group CBT for test anxiety. Two sessions will be carried out each week.
arm group label: Control Group
arm group type: No Intervention
description: The Control group will be waiting for the control group who will receive intervention if they demand after final assessment for outcome measure.
intervention type: Behavioral
intervention name: Group CBT for test anxiety
description: The cognitive-behavioral therapy protocol developed by Flaxman, Bond & Keogh (2004) will be used as the intervention protocol. This protocol consists of 10 Sessions which are provided twice a week (each group will have 10 students).
arm group label: Group Cognitive Behavioral Therapy (Group CBT)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Khem R. Bhatta, Master
role: Principal Investigator
affiliation: Tribhuvan University
facility: 
country: Nepal
responsible party type: Principal Investigator
investigator affiliation: University Grants Commission
investigator full name: Khem Raj Bhatta
investigator title: Principal Investigator
mesh term: Anxiety Disorders