<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/NCT03823261</url>
  </required_header>
  <id_info>
    <org_study_id>4-2018-0755</org_study_id>
    <nct_id>NCT03823261</nct_id>
  </id_info>
  <brief_title>Effects of a Nurse-delivered Cognitive Behaviour Therapy on Adherence and Depressive Symptoms in HIV Infected Persons of South Korea</brief_title>
  <official_title>Effects of a Nurse-delivered Cognitive Behaviour Therapy on Adherence and Depressive Symptoms in HIV Infected Persons of South Korea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei 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>
      Cognitive behaviour therapy (CBT) has repeatedly been found to effectively treat depression&#xD;
      in adult populations, and CBT for adherence and depression (CBT-AD) is an effective treatment&#xD;
      for improving depressive symptoms and medication adherence in the context of various chronic&#xD;
      health conditions, including HIV-infection. However, the effects of CBT have not been&#xD;
      evaluated in South Korea. Even though HIV infection is currently a controllable disease for&#xD;
      patients on successful antiretroviral therapy, people living with HIV (PLWH) are still&#xD;
      suffering from internal and external stigmatization in many Asian countries, including South&#xD;
      Korea. It is not clear whether CBP-AD would be successful intervention among Asian countries&#xD;
      with cultural background of strong stigmatization on HIV/AIDS. We plan to do survey on&#xD;
      facilitators or barriers to patients and providers to identify significant contextual factors&#xD;
      in South Korea. Demographic data and clinical data including CD4+ T cell counts, viral loads,&#xD;
      and antiretroviral therapy regimens will be collected, as well.&#xD;
&#xD;
      Specialists such as psychiatrist or clinical psychologist would be the best provider for CBT&#xD;
      intervention. However, an effective and feasible therapy model should be integrated into&#xD;
      primary HIV care in South Korea. Medical personnel within most HIV clinics in South Korea&#xD;
      include infectious diseases doctors, clinical nurses, and counselling nurses, but CBT&#xD;
      services from psychiatrist or clinical psychologist are not routinely available in many&#xD;
      hospitals. Hospital-based counselling services with experienced nurses have been provided in&#xD;
      many HIV clinics in South Korea, and the counselling nurses would be feasible providers for&#xD;
      CBT intervention of this study. So, we plan to investigate the effects of a nurse-delivered&#xD;
      cognitive behaviour therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">February 29, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective, open-label cohort study without a control, and no blindness.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of depression</measure>
    <time_frame>1 year</time_frame>
    <description>Individual patient would be measured by Beck depression inventory.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of adherence</measure>
    <time_frame>1 year</time_frame>
    <description>Individual patient would be measured by visual analog scale and pill counting.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>1 year</time_frame>
    <description>Individual patient would be measured by PozQoL. PozQoL is a tool measuring quality of life among people with HIV.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy</intervention_name>
    <description>HIV(+) Koreans with depressive symptoms or poor adherence are our target population. This study is a hospital based implementation research. Most PLWH in South Korea regularly visit ID clinics in tertiary hospitals. The ID clinic of study site can reach the target population. In the clinic, the levels of adherence are routinely measured, and depressive symptoms will be asked with key questions We plan to enroll 50 subjects for CBT-AD intervention. In addition, 2 nurses who providing CBT service, and 6 health care workers will be enrolled for survey for providers and healthcare workers.</description>
    <arm_group_label>CBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. HIV(+) Koreans, using ART&#xD;
&#xD;
          2. Adult (19+ years)&#xD;
&#xD;
          3. Having self-reported depressive symptoms or self-reported adherence&lt;90%&#xD;
&#xD;
          4. Being fluent in Korean&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Suicidal ideation&#xD;
&#xD;
          2. Active psychosis&#xD;
&#xD;
          3. Uncontrolled neurological problem&#xD;
&#xD;
          4. Having been initiated on or had their dose of psychotropic medication altered within&#xD;
             the past 3 months&#xD;
&#xD;
          5. Currently receiving psychotherapy for depression&#xD;
&#xD;
          6. Having previously received CBT&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Division of Infectious Diseases, Department of Internal Medicine, Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Jun Yong Choi, MD</last_name>
      <phone>82-2-2228-1974</phone>
      <email>seran@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 27, 2019</last_update_submitted>
  <last_update_submitted_qc>January 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <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/NCT03823261
org study id: 4-2018-0755
nct id: NCT03823261
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cognitive behaviour therapy (CBT) has repeatedly been found to effectively treat depression
      in adult populations, and CBT for adherence and depression (CBT-AD) is an effective treatment
      for improving depressive symptoms and medication adherence in the context of various chronic
      health conditions, including HIV-infection. However, the effects of CBT have not been
      evaluated in South Korea. Even though HIV infection is currently a controllable disease for
      patients on successful antiretroviral therapy, people living with HIV (PLWH) are still
      suffering from internal and external stigmatization in many Asian countries, including South
      Korea. It is not clear whether CBP-AD would be successful intervention among Asian countries
      with cultural background of strong stigmatization on HIV/AIDS. We plan to do survey on
      facilitators or barriers to patients and providers to identify significant contextual factors
      in South Korea. Demographic data and clinical data including CD4+ T cell counts, viral loads,
      and antiretroviral therapy regimens will be collected, as well.

      Specialists such as psychiatrist or clinical psychologist would be the best provider for CBT
      intervention. However, an effective and feasible therapy model should be integrated into
      primary HIV care in South Korea. Medical personnel within most HIV clinics in South Korea
      include infectious diseases doctors, clinical nurses, and counselling nurses, but CBT
      services from psychiatrist or clinical psychologist are not routinely available in many
      hospitals. Hospital-based counselling services with experienced nurses have been provided in
      many HIV clinics in South Korea, and the counselling nurses would be feasible providers for
      CBT intervention of this study. So, we plan to investigate the effects of a nurse-delivered
      cognitive behaviour therapy.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective, open-label cohort study without a control, and no blindness.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Level of depression
time frame: 1 year
description: Individual patient would be measured by Beck depression inventory.
measure: Level of adherence
time frame: 1 year
description: Individual patient would be measured by visual analog scale and pill counting.
measure: Quality of life
time frame: 1 year
description: Individual patient would be measured by PozQoL. PozQoL is a tool measuring quality of life among people with HIV.
arm group label: CBT
arm group type: Experimental
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy
description: HIV(+) Koreans with depressive symptoms or poor adherence are our target population. This study is a hospital based implementation research. Most PLWH in South Korea regularly visit ID clinics in tertiary hospitals. The ID clinic of study site can reach the target population. In the clinic, the levels of adherence are routinely measured, and depressive symptoms will be asked with key questions We plan to enroll 50 subjects for CBT-AD intervention. In addition, 2 nurses who providing CBT service, and 6 health care workers will be enrolled for survey for providers and healthcare workers.
arm group label: CBT
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No