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/NCT06013085</url>
    </required_header>
    <id_info>
      <org_study_id>A202205210</org_study_id>
      <nct_id>NCT06013085</nct_id>
    </id_info>
    <brief_title>Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition</brief_title>
    <acronym>CBT-I</acronym>
    <official_title>Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tri-Service General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tri-Service General Hospital</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>
        Background: Neuropsychiatric conditions, such as insomnia, anxiety, depression, and pain are&#xD;
        the most common symptoms experienced by nurses after acute infection of COVID-19. Although&#xD;
        medication can assist nurses to improve these symptoms simultaneously in a short period of&#xD;
        time, they are at risk of overuse of benzodiazepine hypnotics. Previous research supports the&#xD;
        usefulness of cognitive behavioral therapy for insomnia (CBT-I) as self-management strategies&#xD;
        in adults with insomnia, anxiety, depression, and pain. However, their effects on post&#xD;
        COVID-19 condition have not been researched, and no previous head-to-head study compared the&#xD;
        effects on these two approaches on insomnia and neuropsychiatric symptoms.&#xD;
  &#xD;
        Aim: To investigate the effects of CBT-I on insomnia, anxiety, depression, and pain in nurses&#xD;
        with post COVID-19 condition.&#xD;
  &#xD;
        Methods: In this two-arm, parallel randomized controlled trial, 100 participants will be 1:1&#xD;
        randomly assigned to one of two groups (CBT-I and control). The intervention phase will last&#xD;
        6 weeks, followed by a three-month follow-up. Primary outcomes are insomnia severity and&#xD;
        sleep quality, whereas anxiety, depression, pain, and health-related quality of life are&#xD;
        secondary outcomes. These variables will be assessed before and after the intervention, and&#xD;
        at 1, 2, and 3 months after the end of the intervention. Additionally, discontinuing&#xD;
        benzodiazepine hypnotics will be measured at 3 months after the end of the intervention.&#xD;
  &#xD;
        Discussion: This study will provide evidence of the effects of CBT-I on improving insomnia,&#xD;
        anxiety, depression, and pain among nurses with post COVID-19 condition. Results could also&#xD;
        enhance means by which to discontinue benzodiazepine hypnotics.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2026</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>insomnia severity</measure>
      <time_frame>20 weeks</time_frame>
      <description>measured by Insomnia Severity Index before and after the intervention, and at 1, 2, and 3 months after the end of the intervention</description>
    </primary_outcome>
    <primary_outcome>
      <measure>sleep quality</measure>
      <time_frame>20 weeks</time_frame>
      <description>measured by Pittsburgh Sleep Quality Index</description>
    </primary_outcome>
    <primary_outcome>
      <measure>sleep efficiency</measure>
      <time_frame>20 weeks</time_frame>
      <description>measured by Fitbit Charge 5</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>anxiety</measure>
      <time_frame>20weeks</time_frame>
      <description>measured by Generalized Anxiety Disorder 7-Item</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>depression</measure>
      <time_frame>20weeks</time_frame>
      <description>measured by Patient Health Questionnaire 9 item</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>health-related quality of life</measure>
      <time_frame>20weeks</time_frame>
      <description>measured by 36-Item Short Form Health Survey</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Cognitive Behavioral Therapy</condition>
    <arm_group>
      <arm_group_label>cognitive behavioral therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>6 weeks cognitive-behavioral therapy for insomnia</description>
    </arm_group>
    <arm_group>
      <arm_group_label>treat as usual</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>provide usual care</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>cognitive behavioral therapy</intervention_name>
      <description>6 weeks cognitive behavioral therapy</description>
      <arm_group_label>cognitive behavioral therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  nurses with post COVID-19 condition&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  history of sleep apnea, narcolepsy, pregnant, seizure, with pacemaker&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yu-Mu Hsien, PhD</last_name>
      <phone>886-2-87923311</phone>
      <phone_ext>10552</phone_ext>
      <email>tsghirb@ndmctsgh.edu.tw</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tri-Service General Hospital</investigator_affiliation>
      <investigator_full_name>Wen-Chii Tzeng</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data available on request due to privacy/ethical restrictions</ipd_description>
    </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/NCT06013085
  org study id: A202205210
  nct id: NCT06013085
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Background: Neuropsychiatric conditions, such as insomnia, anxiety, depression, and pain are
        the most common symptoms experienced by nurses after acute infection of COVID-19. Although
        medication can assist nurses to improve these symptoms simultaneously in a short period of
        time, they are at risk of overuse of benzodiazepine hypnotics. Previous research supports the
        usefulness of cognitive behavioral therapy for insomnia (CBT-I) as self-management strategies
        in adults with insomnia, anxiety, depression, and pain. However, their effects on post
        COVID-19 condition have not been researched, and no previous head-to-head study compared the
        effects on these two approaches on insomnia and neuropsychiatric symptoms.
  
        Aim: To investigate the effects of CBT-I on insomnia, anxiety, depression, and pain in nurses
        with post COVID-19 condition.
  
        Methods: In this two-arm, parallel randomized controlled trial, 100 participants will be 1:1
        randomly assigned to one of two groups (CBT-I and control). The intervention phase will last
        6 weeks, followed by a three-month follow-up. Primary outcomes are insomnia severity and
        sleep quality, whereas anxiety, depression, pain, and health-related quality of life are
        secondary outcomes. These variables will be assessed before and after the intervention, and
        at 1, 2, and 3 months after the end of the intervention. Additionally, discontinuing
        benzodiazepine hypnotics will be measured at 3 months after the end of the intervention.
  
        Discussion: This study will provide evidence of the effects of CBT-I on improving insomnia,
        anxiety, depression, and pain among nurses with post COVID-19 condition. Results could also
        enhance means by which to discontinue benzodiazepine hypnotics.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: insomnia severity
  time frame: 20 weeks
  description: measured by Insomnia Severity Index before and after the intervention, and at 1, 2, and 3 months after the end of the intervention
  measure: sleep quality
  time frame: 20 weeks
  description: measured by Pittsburgh Sleep Quality Index
  measure: sleep efficiency
  time frame: 20 weeks
  description: measured by Fitbit Charge 5
  measure: anxiety
  time frame: 20weeks
  description: measured by Generalized Anxiety Disorder 7-Item
  measure: depression
  time frame: 20weeks
  description: measured by Patient Health Questionnaire 9 item
  measure: health-related quality of life
  time frame: 20weeks
  description: measured by 36-Item Short Form Health Survey
  arm group label: cognitive behavioral therapy
  arm group type: Experimental
  description: 6 weeks cognitive-behavioral therapy for insomnia
  arm group label: treat as usual
  arm group type: No Intervention
  description: provide usual care
  intervention type: Behavioral
  intervention name: cognitive behavioral therapy
  description: 6 weeks cognitive behavioral therapy
  arm group label: cognitive behavioral therapy
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yu-Mu Hsien, PhD
  phone: 886-2-87923311
  phone ext: 10552
  email: tsghirb@ndmctsgh.edu.tw
  responsible party type: Principal Investigator
  investigator affiliation: Tri-Service General Hospital
  investigator full name: Wen-Chii Tzeng
  investigator title: Professor
  mesh term: Sleep Initiation and Maintenance Disorders
  sharing ipd: No
  ipd description: Data available on request due to privacy/ethical restrictions