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/NCT05995938</url>
    </required_header>
    <id_info>
      <org_study_id>2022/3884</org_study_id>
      <nct_id>NCT05995938</nct_id>
    </id_info>
    <brief_title>Mindfullnes-Based Cognitive Therapy Effect</brief_title>
    <acronym>[Mindfullnes]</acronym>
    <official_title>Mindfullnes-Based in Surgery Patients for Cognitive Therapy Effect</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>SEMRA BÜLBÜLOĞLU</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Aydın 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>
        Objective: In this study, the effect of mindfulness-based cognitive therapy on compliance&#xD;
        with immunosuppressive therapy in liver transplant patients was evaluated. Method: It was&#xD;
        conducted the study in a randomized controlled type with n=120 participation of liver&#xD;
        transplant recipients of a transplant hospital. It was applied mindfulness-based cognitive&#xD;
        therapy to liver recipients in the experimental group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It was used simple random sampling method in assigning liver recipients to the experimental&#xD;
        and control groups. Discharged liver transplant patients are informed about the use of&#xD;
        immunosuppressive drugs and the drug is prescribed. Liver transplant patients drugs.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Actual">January 30, 2023</completion_date>
    <primary_completion_date type="Actual">January 1, 2023</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Experimental</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The Effect of Mindfulness-Based Cognitive after Liver Transplantation</measure>
      <time_frame>Both groups experiment and control. It was used Mindfullnes scale and immunosuppressive terapy adherence scale. It was done measure before and after Mindfullnes-Based Cognitive Therapy.</time_frame>
      <description>It will be measure Therapy on Liver Transplant Recipients' Adherence to Immunosuppressive Therapy</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mindfullnes-Based Cognitive Therapy</measure>
      <time_frame>total of six month.from 1 october 2022 to 30 Jan 2023</time_frame>
      <description>le level of Mindfulness-Based Cognitive</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">140</enrollment>
    <condition>Mindfullnes-Based Cognitive Therapy and Adherence to Immunosuppressive Therapy</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>1</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>1</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfullnes-Based Cognitive Therapy</intervention_name>
      <description>Mindfullnes-Based Cognitive Therapy Effect on Adherence to Immunosuppressive Therapy in Liver Transplant Recipients</description>
      <arm_group_label>Experimental</arm_group_label>
      <other_name>[Mindfulness]</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Inclusion Criteria involved (i) being a liver transplant recipient, (ii) currently&#xD;
               having immunosuppressive treatment, (iii) being 18 years or older (iv) having no&#xD;
               language or communication barrier and (v) agreeing to participate in the study.&#xD;
  &#xD;
          Liver transplant recipients&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The exact opposite of the inclusion criteria the exclusion criteria.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>the Liver Transplant Hospital affiliated with Turgut Özal Medical Center of İnönü University of Malatya/Turkey.</name>
        <address>
          <city>Malatya</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Aydın University</investigator_affiliation>
      <investigator_full_name>SEMRA BÜLBÜLOĞLU</investigator_full_name>
      <investigator_title>Clinical Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Liver Recipients</keyword>
    <keyword>Transplantation</keyword>
    <keyword>Mindfulness</keyword>
    <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/NCT05995938
  org study id: 2022/3884
  nct id: NCT05995938
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Objective: In this study, the effect of mindfulness-based cognitive therapy on compliance
        with immunosuppressive therapy in liver transplant patients was evaluated. Method: It was
        conducted the study in a randomized controlled type with n=120 participation of liver
        transplant recipients of a transplant hospital. It was applied mindfulness-based cognitive
        therapy to liver recipients in the experimental group.
  It was used simple random sampling method in assigning liver recipients to the experimental
        and control groups. Discharged liver transplant patients are informed about the use of
        immunosuppressive drugs and the drug is prescribed. Liver transplant patients drugs.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Experimental
  primary purpose: Basic Science
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: The Effect of Mindfulness-Based Cognitive after Liver Transplantation
  time frame: Both groups experiment and control. It was used Mindfullnes scale and immunosuppressive terapy adherence scale. It was done measure before and after Mindfullnes-Based Cognitive Therapy.
  description: It will be measure Therapy on Liver Transplant Recipients' Adherence to Immunosuppressive Therapy
  measure: Mindfullnes-Based Cognitive Therapy
  time frame: total of six month.from 1 october 2022 to 30 Jan 2023
  description: le level of Mindfulness-Based Cognitive
  arm group label: Experimental
  arm group type: Experimental
  description: 1
  arm group label: Control
  arm group type: No Intervention
  description: 1
  intervention type: Behavioral
  intervention name: Mindfullnes-Based Cognitive Therapy
  description: Mindfullnes-Based Cognitive Therapy Effect on Adherence to Immunosuppressive Therapy in Liver Transplant Recipients
  arm group label: Experimental
  other name: [Mindfulness]
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Istanbul Aydın University
  investigator full name: SEMRA BÜLBÜLOĞLU
  investigator title: Clinical Associate Professor
  sharing ipd: No