xml: <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/NCT06037005</url>
    </required_header>
    <id_info>
      <org_study_id>BDTNurse</org_study_id>
      <nct_id>NCT06037005</nct_id>
    </id_info>
    <brief_title>The Effect of Cognitive Behavioral Therapy on Post-Traumatic Stress Symptoms in Nursing Students</brief_title>
    <official_title>The Effect of Cognitive Behavioral Therapy on Post-Traumatic Stress Symptoms in Nursing Students in the COVID 19 Process: Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Necmettin Erbakan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Necmettin Erbakan University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Objectives: This research was planned to examine the effect of cognitive behavioral therapy&#xD;
        on the post-traumatic stress symptoms of nursing students during the COVID-19 pandemic.&#xD;
  &#xD;
        Design: Single-blinded study with parallel groups. Setting: Faculty of Nursing. Participants:&#xD;
        60 first-year students studying at the Faculty of Nursing were randomly assigned to the&#xD;
        intervention (n=30) and control (n=30) groups.&#xD;
  &#xD;
        Method: Data were collected using the Information Form prepared by the researcher and the&#xD;
        Post Traumatic Stress Disorder Checklist for DSM-5. The intervention group was collected&#xD;
        online three times, before the cognitive behavioral group therapy, at the end of the therapy&#xD;
        and three months later. Group intervention program based on cognitive behavioral approach of&#xD;
        ten sessions; face-to-face, the intervention group was divided into two separate groups and&#xD;
        each group was completed in approximately one and a half months (May-June 2022), two days a&#xD;
        week. Follow-up measurement was completed in September 2022. While group therapy was applied&#xD;
        to the intervention group, no intervention was made to the control group.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">May 10, 2022</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Actual">September 30, 2022</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>
      <intervention_model_description>Single-blinded study with parallel groups.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>In the study, data collection, statistics and reporting were blinded. The collection of research data and data entry (pre-tests and post-tests and transferring the data to the computer) were carried out by an instructor other than the researcher, who was unaware of the intervention and control groups. Data entries were entered with &quot;A&quot; and &quot;B&quot; codes without specifying the intervention or control group. The analysis of the data and the writing of the research report were coded as &quot;A&quot; and &quot;B&quot; groups. After the statistical analysis was made and the research report was written, the coding for the intervention and control groups was explained to the researcher by the coder.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)</measure>
      <time_frame>First assessment will be made at the baseline (pre-intervention)</time_frame>
      <description>Using the Post-Traumatic Stress Disorder Checklist for the DSM-5, symptoms of post-traumatic stress are assessed. Scores ranging from 0 to 80 points are obtained in the scale. In the interpretation of the results of the scale, it gives information about the level of symptoms by calculating the total symptom score together with the sum of the scores of the symptoms in each item, and it is recommended to use 28 as the cut-off point, although it varies according to the purpose of use (Blevins et al., 2015).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)</measure>
      <time_frame>The second assessment will take place 5 weeks after the first assessment (after the program is completed).</time_frame>
      <description>Using the Post-Traumatic Stress Disorder Checklist for the DSM-5, symptoms of post-traumatic stress are assessed. Scores ranging from 0 to 80 points are obtained in the scale. In the interpretation of the results of the scale, it gives information about the level of symptoms by calculating the total symptom score together with the sum of the scores of the symptoms in each item, and it is recommended to use 28 as the cut-off point, although it varies according to the purpose of use (Blevins et al., 2015).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)</measure>
      <time_frame>Third assessment will take place average 12 weeks after the second assessment.</time_frame>
      <description>Using the Post-Traumatic Stress Disorder Checklist for the DSM-5, symptoms of post-traumatic stress are assessed. Scores ranging from 0 to 80 points are obtained in the scale. In the interpretation of the results of the scale, it gives information about the level of symptoms by calculating the total symptom score together with the sum of the scores of the symptoms in each item, and it is recommended to use 28 as the cut-off point, although it varies according to the purpose of use (Blevins et al., 2015).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Trauma and Stressor Related Disorders</condition>
    <arm_group>
      <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Expert support was received from the Cognitive Behavioral Psychotherapy Practitioner and Trainer of the Turkish Psychiatric Association in the creation of the sessions. The researcher applying the therapy has a CBT practitioner certificate. Group intervention program based on cognitive behavioral approach of ten sessions; It was completed in approximately one and a half months (May-June 2022) in the Faculty of Nursing, by dividing the experimental group into two separate groups, two days a week for each group. Each session was held for approximately one hour. The last measurement was made three months after the last therapy session (September 2022).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>While group therapy was applied to the experimental group, no intervention was made to the control group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cognitive Behavioral Therapy Group</intervention_name>
      <description>Group intervention program based on cognitive behavioral approach of ten sessions; It was completed in approximately one and a half months (May-June 2022) in the Faculty of Nursing, by dividing the experimental group into two separate groups, two days a week for each group. Each session was held for approximately one hour. The last measurement was made three months after the last therapy session (September 2022).</description>
      <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being a first year nursing student&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Being a foreign student&#xD;
  &#xD;
            -  Having a psychiatric diagnosis&#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>
    <location>
      <facility>
        <name>Fatma Yener Özcan</name>
        <address>
          <city>Meram</city>
          <state>Konya</state>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Burcu CEYLAN</name>
        <address>
          <city>Tekirdağ</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Necmettin Erbakan University</investigator_affiliation>
      <investigator_full_name>Fatma Yener Ozcan</investigator_full_name>
      <investigator_title>Research Assistant</investigator_title>
    </responsible_party>
    <keyword>Nurse</keyword>
    <keyword>Therapy</keyword>
    <keyword>Post-Traumatic Stress</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Trauma and Stressor Related Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037005
  org study id: BDTNurse
  nct id: NCT06037005
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Objectives: This research was planned to examine the effect of cognitive behavioral therapy
        on the post-traumatic stress symptoms of nursing students during the COVID-19 pandemic.
  
        Design: Single-blinded study with parallel groups. Setting: Faculty of Nursing. Participants:
        60 first-year students studying at the Faculty of Nursing were randomly assigned to the
        intervention (n=30) and control (n=30) groups.
  
        Method: Data were collected using the Information Form prepared by the researcher and the
        Post Traumatic Stress Disorder Checklist for DSM-5. The intervention group was collected
        online three times, before the cognitive behavioral group therapy, at the end of the therapy
        and three months later. Group intervention program based on cognitive behavioral approach of
        ten sessions; face-to-face, the intervention group was divided into two separate groups and
        each group was completed in approximately one and a half months (May-June 2022), two days a
        week. Follow-up measurement was completed in September 2022. While group therapy was applied
        to the intervention group, no intervention was made to the control group.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Single-blinded study with parallel groups.
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  masking description: In the study, data collection, statistics and reporting were blinded. The collection of research data and data entry (pre-tests and post-tests and transferring the data to the computer) were carried out by an instructor other than the researcher, who was unaware of the intervention and control groups. Data entries were entered with "A" and "B" codes without specifying the intervention or control group. The analysis of the data and the writing of the research report were coded as "A" and "B" groups. After the statistical analysis was made and the research report was written, the coding for the intervention and control groups was explained to the researcher by the coder.
  measure: Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
  time frame: First assessment will be made at the baseline (pre-intervention)
  description: Using the Post-Traumatic Stress Disorder Checklist for the DSM-5, symptoms of post-traumatic stress are assessed. Scores ranging from 0 to 80 points are obtained in the scale. In the interpretation of the results of the scale, it gives information about the level of symptoms by calculating the total symptom score together with the sum of the scores of the symptoms in each item, and it is recommended to use 28 as the cut-off point, although it varies according to the purpose of use (Blevins et al., 2015).
  measure: Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
  time frame: The second assessment will take place 5 weeks after the first assessment (after the program is completed).
  description: Using the Post-Traumatic Stress Disorder Checklist for the DSM-5, symptoms of post-traumatic stress are assessed. Scores ranging from 0 to 80 points are obtained in the scale. In the interpretation of the results of the scale, it gives information about the level of symptoms by calculating the total symptom score together with the sum of the scores of the symptoms in each item, and it is recommended to use 28 as the cut-off point, although it varies according to the purpose of use (Blevins et al., 2015).
  measure: Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
  time frame: Third assessment will take place average 12 weeks after the second assessment.
  description: Using the Post-Traumatic Stress Disorder Checklist for the DSM-5, symptoms of post-traumatic stress are assessed. Scores ranging from 0 to 80 points are obtained in the scale. In the interpretation of the results of the scale, it gives information about the level of symptoms by calculating the total symptom score together with the sum of the scores of the symptoms in each item, and it is recommended to use 28 as the cut-off point, although it varies according to the purpose of use (Blevins et al., 2015).
  arm group label: Cognitive Behavioral Therapy
  arm group type: Experimental
  description: Expert support was received from the Cognitive Behavioral Psychotherapy Practitioner and Trainer of the Turkish Psychiatric Association in the creation of the sessions. The researcher applying the therapy has a CBT practitioner certificate. Group intervention program based on cognitive behavioral approach of ten sessions; It was completed in approximately one and a half months (May-June 2022) in the Faculty of Nursing, by dividing the experimental group into two separate groups, two days a week for each group. Each session was held for approximately one hour. The last measurement was made three months after the last therapy session (September 2022).
  arm group label: Control
  arm group type: No Intervention
  description: While group therapy was applied to the experimental group, no intervention was made to the control group.
  intervention type: Other
  intervention name: Cognitive Behavioral Therapy Group
  description: Group intervention program based on cognitive behavioral approach of ten sessions; It was completed in approximately one and a half months (May-June 2022) in the Faculty of Nursing, by dividing the experimental group into two separate groups, two days a week for each group. Each session was held for approximately one hour. The last measurement was made three months after the last therapy session (September 2022).
  arm group label: Cognitive Behavioral Therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Necmettin Erbakan University
  investigator full name: Fatma Yener Ozcan
  investigator title: Research Assistant
  mesh term: Trauma and Stressor Related Disorders
  sharing ipd: No