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/NCT06021236</url>
    </required_header>
    <id_info>
      <org_study_id>MKC-23MMHIS220e</org_study_id>
      <secondary_id>23MMHIS220e</secondary_id>
      <nct_id>NCT06021236</nct_id>
    </id_info>
    <brief_title>Efficacy of a Mindfulness-Based Intervention in Patients With Cardiovascular Implantable Electronic Device</brief_title>
    <acronym>MBI-CIED</acronym>
    <official_title>Efficacy of a Mindfulness-Based Intervention on Resilience, Perceived Stress, Anxiety, and Depression, in Patients With Cardiovascular Implantable Electronic Device: A Mixed-Methods Research</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chien Chih-Yin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Taipei University of Nursing and Health Sciences</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>National Taipei University of Nursing and Health Sciences</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>
        An implantable cardiac defibrillator (implantable cardioverter-defibrillator; ICD) can&#xD;
        effectively improve heart rhythm problems and reduce sudden death, and is widely used in the&#xD;
        treatment of high-risk patients with fatal arrhythmias or heart rhythm problems that cannot&#xD;
        be controlled by drugs . In the whole case of arrhythmia, after receiving home-based cardiac&#xD;
        fibrillator treatment, Patients often experience uncertainty, feel the changes in heart, feel&#xD;
        the shock of being shocked by the electric shock, and worry about death, These psychological&#xD;
        distress, which were characterized by anxiety and depression. for universal. About 25% of&#xD;
        patients present with symptoms of anxiety at the time of hospitalization, and 50% suffer from&#xD;
        depression which seriously affects quality of life. Therefore, the main purpose of this study&#xD;
        to alleviate the occurrence of anxiety and depression, promote disease patients to regain&#xD;
        life adaptation, develop accessible care strategies with midfulness-based intervention to&#xD;
        help patients overcome psychological distress, reduce stress, anxiety and prevent depression.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study with randomized clinical trial design (randomized clinical trial) and qualitative&#xD;
        research, which is a qualitative mixed-methods research. Patients were randomly assigned to&#xD;
        the experimental group and the control group in a 1:1 manner. The experimental group received&#xD;
        the mindfulness-based intervention designed and routine care , and the control group received&#xD;
        general routine care. Both groups completed a total of four questionnaires at the pretest&#xD;
        (T0), discharge (T1), the first month of discharge (T2), and the third month of discharge&#xD;
        (T3), including anxiety, depression, resilience, stress perception scale and other basic data&#xD;
        such as demographics and disease characteristics were collected in the pretest.&#xD;
  &#xD;
        This study held an expert meeting to extract the techniques of mindfulness measures suitable&#xD;
        for this disease attribute and the elderly group, including: breathing awareness, body&#xD;
        scanning, mindful yoga, mindful eating, and loving-kindness meditation. From the time when&#xD;
        the patient signed up for the first cardiac device surgery schedule, the experimental group&#xD;
        who met the including criteria followed the routine care of the hospital and was involved in&#xD;
        teaching the above mindfulness skills, while the control group still followed the routine&#xD;
        care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2024</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>This study is a randomized clinical trial design (randomized clinical trial) with qualitative analysis, which is a mixed-methods research. Research objects were randomly assigned to the experimental and control groups in a 1:1 manner. The experimental group received the mindfulness-based intervention designed and routine care, and the control group received usual care. A total of four questionnaires were filled in the pretest (T0), the first month of discharge (T1), the 3rd month of discharge(T2), and the 6th month of discharge (T3), including anxiety, depression, mental toughness, and stress perception. Qualitative interviews were conducted at T2 and T3 to understand the improvement of psychological problems.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Anxiety</measure>
      <time_frame>From enrollment to the end of treatment at 6 months</time_frame>
      <description>This study used the Hospital Anxiety and Depression Scale (HADS) to assess anxiety in patients. This scale provides anxiety (HADS-A) scores.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Resilience</measure>
      <time_frame>From enrollment to the end of treatment at 6 months</time_frame>
      <description>This study uses the Connor-Davidson Resilience Scale (Connor-Davidson Resilience Scale), which was developed by Connor and Davidson (2003) in the United States who regarded resilience as a measurable stress response ability.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived Stress</measure>
      <time_frame>From enrollment to the end of treatment at 6 months</time_frame>
      <description>This study uses the Perceived Stress Scale, which was compiled by Cohen et al. (1983) and translated from the Chinese version of Chu and Gao (2005). , the degree of stress in life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depression</measure>
      <time_frame>From enrollment to the end of treatment at 6 months</time_frame>
      <description>This study used the Hospital Anxiety and Depression Scale (HADS) to assess depression in patients. This scale provides anxiety (HADS-D) scores.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Demographic Information</measure>
      <time_frame>From enrollment to the end of treatment at 6 months</time_frame>
      <description>Collect age, gender, education level, marital status, occupation, smoking, drinking, disease history, other disease history, and exercise habits with self-made basic data sheets.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>body mass index</measure>
      <time_frame>From enrollment to the end of treatment at 6 months</time_frame>
      <description>weight and height will be combined to report BMI in kg/m^2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feelings and experiences by interview of home-based cardiac device patients receiving pre-procedure mindfulness intervention program</measure>
      <time_frame>From enrollment to the end of treatment at 6 months</time_frame>
      <description>Intentional sampling with phenomenological method. Conduct one-on-one interview recordings for the research subjects in the experimental group to collect the feelings and experiences of patients with implanted cardiac devices who received the mindfulness-based preoperative intervention program. It is expected to close the case until the data is saturated.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">68</enrollment>
    <condition>Mindfulness Training</condition>
    <condition>Cardiac Resynchronization Therapy Devices</condition>
    <condition>Resilience, Psychological</condition>
    <condition>Anxiety</condition>
    <condition>Depression</condition>
    <condition>Perceived Stress</condition>
    <arm_group>
      <arm_group_label>mindfulness-based intervention and routine care</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>mindfulness-based intervention including: breathing awareness, body scanning, mindful yoga, mindful eating, and loving-kindness meditation. From the time when the patients signed up to be the first to receive the cardiac device surgery schedule, the experimental group that met the including criteria, in addition to following the routine care of the hospital, was involved in teaching the above mindfulness skills, and Osaka continued to follow the regular care.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>The control group received the CIED procedure routine care</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>From the time when the patients signed up to be the first to receive the cardiac device surgery schedule, the control group that met the including criteria take routine care of the hospital.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>mindfulness-based intervention</intervention_name>
      <description>Diet meditation breath awareness body scan mindfulness yoga Compassionate blessing</description>
      <arm_group_label>mindfulness-based intervention and routine care</arm_group_label>
      <other_name>mindfulness-based intervention with CIED procedure routine care</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>CIED procedure routine care</intervention_name>
      <description>CIED procedure home care guidance</description>
      <arm_group_label>The control group received the CIED procedure routine care</arm_group_label>
      <arm_group_label>mindfulness-based intervention and routine care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients receiving implanted cardiac devices for the first time (including cardiac&#xD;
               defibrillator ICD and Pacemaker).&#xD;
  &#xD;
            2. Adults over 20 years old.&#xD;
  &#xD;
            3. Those who have clear consciousness and can communicate in Chinese and Taiwanese.&#xD;
  &#xD;
            4. Score of 8 or above on the Hospital Anxiety or Depression Scale.&#xD;
  &#xD;
            5. Barthel Index above 70 points.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Diagnosed with dementia by a physician.&#xD;
  &#xD;
            2. Diagnosed with mental disorders, including cognitive disorders, organic psychosis and&#xD;
               affective psychosis.&#xD;
  &#xD;
            3. Patients who have been diagnosed with cancer.&#xD;
  &#xD;
            4. Long-term bed ridden.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chih Yin Chien, PI</last_name>
      <role>Study Chair</role>
      <affiliation>MKC/MMH</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chih Yin Chien, PhD Candidates</last_name>
      <phone>+886-2-28584180</phone>
      <phone_ext>2234</phone_ext>
      <email>s157@mail.mkc.edu.tw</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>TsaeJyy Wang, PhD</last_name>
      <phone>+886-2+28227101</phone>
      <phone_ext>3118</phone_ext>
      <email>tsaejyy@ntunhs.edu.tw</email>
    </overall_contact_backup>
    <results_reference>
      <citation>Freedenberg VA, Thomas SA, Friedmann E. A pilot study of a mindfulness based stress reduction program in adolescents with implantable cardioverter defibrillators or pacemakers. Pediatr Cardiol. 2015 Apr;36(4):786-95. doi: 10.1007/s00246-014-1081-5. Epub 2014 Dec 12.</citation>
      <PMID>25519914</PMID>
    </results_reference>
    <results_reference>
      <citation>Hazlett-Stevens H, Singer J, Chong A. Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy with Older Adults: A Qualitative Review of Randomized Controlled Outcome Research. Clin Gerontol. 2019 Jul-Sep;42(4):347-358. doi: 10.1080/07317115.2018.1518282. Epub 2018 Sep 11.</citation>
      <PMID>30204557</PMID>
    </results_reference>
    <results_reference>
      <citation>Hopgood DA, Czosek RJ, Bakas T, Garritano N, Gillespie GL. The Capture Gap: Implantable Cardioverter-Defibrillator Quality of Life. Clin Nurs Res. 2020 Feb;29(2):97-107. doi: 10.1177/1054773818803741. Epub 2018 Oct 7.</citation>
      <PMID>30295057</PMID>
    </results_reference>
    <results_reference>
      <citation>Li SYH, Bressington D. The effects of mindfulness-based stress reduction on depression, anxiety, and stress in older adults: A systematic review and meta-analysis. Int J Ment Health Nurs. 2019 Jun;28(3):635-656. doi: 10.1111/inm.12568. Epub 2019 Jan 17.</citation>
      <PMID>30656813</PMID>
    </results_reference>
    <results_reference>
      <citation>Marino F, Failla C, Carrozza C, Ciminata M, Chila P, Minutoli R, Genovese S, Puglisi A, Arnao AA, Tartarisco G, Corpina F, Gangemi S, Ruta L, Cerasa A, Vagni D, Pioggia G. Mindfulness-Based Interventions for Physical and Psychological Wellbeing in Cardiovascular Diseases: A Systematic Review and Meta-Analysis. Brain Sci. 2021 May 29;11(6):727. doi: 10.3390/brainsci11060727.</citation>
      <PMID>34072605</PMID>
    </results_reference>
    <results_reference>
      <citation>Rafsanjani MHAP, Masoudi S, Radmanesh M, Bostani Z. Comparison of depression and anxiety among pacemaker and implantable cardioverter-defibrillator recipients: A cross-sectional study. Pacing Clin Electrophysiol. 2021 Feb;44(2):235-239. doi: 10.1111/pace.14152. Epub 2021 Jan 12.</citation>
      <PMID>33372277</PMID>
    </results_reference>
    <results_reference>
      <citation>Schulz SM, Ritter O, Zniva R, Nordbeck P, Wacker C, Jack M, Groschup G, Deneke T, Puppe F, Ertl G, Angermann C, Stork S, Pauli P. Efficacy of a web-based intervention for improving psychosocial well-being in patients with implantable cardioverter-defibrillators: the randomized controlled ICD-FORUM trial. Eur Heart J. 2020 Mar 14;41(11):1203-1211. doi: 10.1093/eurheartj/ehz134.</citation>
      <PMID>30957867</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>National Taipei University of Nursing and Health Sciences</investigator_affiliation>
      <investigator_full_name>Chien Chih-Yin</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </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>
      <ipd_description>The research data belongs to the researcher and is expected to be destroyed after 2 years</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/NCT06021236
  org study id: MKC-23MMHIS220e
  secondary id: 23MMHIS220e
  nct id: NCT06021236
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  An implantable cardiac defibrillator (implantable cardioverter-defibrillator; ICD) can
        effectively improve heart rhythm problems and reduce sudden death, and is widely used in the
        treatment of high-risk patients with fatal arrhythmias or heart rhythm problems that cannot
        be controlled by drugs . In the whole case of arrhythmia, after receiving home-based cardiac
        fibrillator treatment, Patients often experience uncertainty, feel the changes in heart, feel
        the shock of being shocked by the electric shock, and worry about death, These psychological
        distress, which were characterized by anxiety and depression. for universal. About 25% of
        patients present with symptoms of anxiety at the time of hospitalization, and 50% suffer from
        depression which seriously affects quality of life. Therefore, the main purpose of this study
        to alleviate the occurrence of anxiety and depression, promote disease patients to regain
        life adaptation, develop accessible care strategies with midfulness-based intervention to
        help patients overcome psychological distress, reduce stress, anxiety and prevent depression.
  This study with randomized clinical trial design (randomized clinical trial) and qualitative
        research, which is a qualitative mixed-methods research. Patients were randomly assigned to
        the experimental group and the control group in a 1:1 manner. The experimental group received
        the mindfulness-based intervention designed and routine care , and the control group received
        general routine care. Both groups completed a total of four questionnaires at the pretest
        (T0), discharge (T1), the first month of discharge (T2), and the third month of discharge
        (T3), including anxiety, depression, resilience, stress perception scale and other basic data
        such as demographics and disease characteristics were collected in the pretest.
  
        This study held an expert meeting to extract the techniques of mindfulness measures suitable
        for this disease attribute and the elderly group, including: breathing awareness, body
        scanning, mindful yoga, mindful eating, and loving-kindness meditation. From the time when
        the patient signed up for the first cardiac device surgery schedule, the experimental group
        who met the including criteria followed the routine care of the hospital and was involved in
        teaching the above mindfulness skills, while the control group still followed the routine
        care.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study is a randomized clinical trial design (randomized clinical trial) with qualitative analysis, which is a mixed-methods research. Research objects were randomly assigned to the experimental and control groups in a 1:1 manner. The experimental group received the mindfulness-based intervention designed and routine care, and the control group received usual care. A total of four questionnaires were filled in the pretest (T0), the first month of discharge (T1), the 3rd month of discharge(T2), and the 6th month of discharge (T3), including anxiety, depression, mental toughness, and stress perception. Qualitative interviews were conducted at T2 and T3 to understand the improvement of psychological problems.
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: Anxiety
  time frame: From enrollment to the end of treatment at 6 months
  description: This study used the Hospital Anxiety and Depression Scale (HADS) to assess anxiety in patients. This scale provides anxiety (HADS-A) scores.
  measure: Resilience
  time frame: From enrollment to the end of treatment at 6 months
  description: This study uses the Connor-Davidson Resilience Scale (Connor-Davidson Resilience Scale), which was developed by Connor and Davidson (2003) in the United States who regarded resilience as a measurable stress response ability.
  measure: Perceived Stress
  time frame: From enrollment to the end of treatment at 6 months
  description: This study uses the Perceived Stress Scale, which was compiled by Cohen et al. (1983) and translated from the Chinese version of Chu and Gao (2005). , the degree of stress in life.
  measure: Depression
  time frame: From enrollment to the end of treatment at 6 months
  description: This study used the Hospital Anxiety and Depression Scale (HADS) to assess depression in patients. This scale provides anxiety (HADS-D) scores.
  measure: Demographic Information
  time frame: From enrollment to the end of treatment at 6 months
  description: Collect age, gender, education level, marital status, occupation, smoking, drinking, disease history, other disease history, and exercise habits with self-made basic data sheets.
  measure: body mass index
  time frame: From enrollment to the end of treatment at 6 months
  description: weight and height will be combined to report BMI in kg/m^2
  measure: Feelings and experiences by interview of home-based cardiac device patients receiving pre-procedure mindfulness intervention program
  time frame: From enrollment to the end of treatment at 6 months
  description: Intentional sampling with phenomenological method. Conduct one-on-one interview recordings for the research subjects in the experimental group to collect the feelings and experiences of patients with implanted cardiac devices who received the mindfulness-based preoperative intervention program. It is expected to close the case until the data is saturated.
  arm group label: mindfulness-based intervention and routine care
  arm group type: Experimental
  description: mindfulness-based intervention including: breathing awareness, body scanning, mindful yoga, mindful eating, and loving-kindness meditation. From the time when the patients signed up to be the first to receive the cardiac device surgery schedule, the experimental group that met the including criteria, in addition to following the routine care of the hospital, was involved in teaching the above mindfulness skills, and Osaka continued to follow the regular care.
  arm group label: The control group received the CIED procedure routine care
  arm group type: Other
  description: From the time when the patients signed up to be the first to receive the cardiac device surgery schedule, the control group that met the including criteria take routine care of the hospital.
  intervention type: Behavioral
  intervention name: mindfulness-based intervention
  description: Diet meditation breath awareness body scan mindfulness yoga Compassionate blessing
  arm group label: mindfulness-based intervention and routine care
  other name: mindfulness-based intervention with CIED procedure routine care
  intervention type: Other
  intervention name: CIED procedure routine care
  description: CIED procedure home care guidance
  arm group label: The control group received the CIED procedure routine care
  arm group label: mindfulness-based intervention and routine care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Chih Yin Chien, PI
  role: Study Chair
  affiliation: MKC/MMH
  last name: Chih Yin Chien, PhD Candidates
  phone: +886-2-28584180
  phone ext: 2234
  email: s157@mail.mkc.edu.tw
  last name: TsaeJyy Wang, PhD
  phone: +886-2+28227101
  phone ext: 3118
  email: tsaejyy@ntunhs.edu.tw
  citation: Freedenberg VA, Thomas SA, Friedmann E. A pilot study of a mindfulness based stress reduction program in adolescents with implantable cardioverter defibrillators or pacemakers. Pediatr Cardiol. 2015 Apr;36(4):786-95. doi: 10.1007/s00246-014-1081-5. Epub 2014 Dec 12.
  PMID: 25519914
  citation: Hazlett-Stevens H, Singer J, Chong A. Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy with Older Adults: A Qualitative Review of Randomized Controlled Outcome Research. Clin Gerontol. 2019 Jul-Sep;42(4):347-358. doi: 10.1080/07317115.2018.1518282. Epub 2018 Sep 11.
  PMID: 30204557
  citation: Hopgood DA, Czosek RJ, Bakas T, Garritano N, Gillespie GL. The Capture Gap: Implantable Cardioverter-Defibrillator Quality of Life. Clin Nurs Res. 2020 Feb;29(2):97-107. doi: 10.1177/1054773818803741. Epub 2018 Oct 7.
  PMID: 30295057
  citation: Li SYH, Bressington D. The effects of mindfulness-based stress reduction on depression, anxiety, and stress in older adults: A systematic review and meta-analysis. Int J Ment Health Nurs. 2019 Jun;28(3):635-656. doi: 10.1111/inm.12568. Epub 2019 Jan 17.
  PMID: 30656813
  citation: Marino F, Failla C, Carrozza C, Ciminata M, Chila P, Minutoli R, Genovese S, Puglisi A, Arnao AA, Tartarisco G, Corpina F, Gangemi S, Ruta L, Cerasa A, Vagni D, Pioggia G. Mindfulness-Based Interventions for Physical and Psychological Wellbeing in Cardiovascular Diseases: A Systematic Review and Meta-Analysis. Brain Sci. 2021 May 29;11(6):727. doi: 10.3390/brainsci11060727.
  PMID: 34072605
  citation: Rafsanjani MHAP, Masoudi S, Radmanesh M, Bostani Z. Comparison of depression and anxiety among pacemaker and implantable cardioverter-defibrillator recipients: A cross-sectional study. Pacing Clin Electrophysiol. 2021 Feb;44(2):235-239. doi: 10.1111/pace.14152. Epub 2021 Jan 12.
  PMID: 33372277
  citation: Schulz SM, Ritter O, Zniva R, Nordbeck P, Wacker C, Jack M, Groschup G, Deneke T, Puppe F, Ertl G, Angermann C, Stork S, Pauli P. Efficacy of a web-based intervention for improving psychosocial well-being in patients with implantable cardioverter-defibrillators: the randomized controlled ICD-FORUM trial. Eur Heart J. 2020 Mar 14;41(11):1203-1211. doi: 10.1093/eurheartj/ehz134.
  PMID: 30957867
  responsible party type: Sponsor-Investigator
  investigator affiliation: National Taipei University of Nursing and Health Sciences
  investigator full name: Chien Chih-Yin
  investigator title: Director
  mesh term: Depression
  sharing ipd: No
  ipd description: The research data belongs to the researcher and is expected to be destroyed after 2 years