<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/NCT03233451</url>
  </required_header>
  <id_info>
    <org_study_id>2016-1-4117</org_study_id>
    <nct_id>NCT03233451</nct_id>
  </id_info>
  <brief_title>Psycho-behavioral Intervention for Depression in Chronic Heart Failure</brief_title>
  <official_title>Effect of Psycho-behavioral Intervention on the Depression, Cardiac Function and Quality of Life in Older Adults With Chronic Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking 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>
      The study aims to explore the effectiveness of psycho-behavioral intervention on depressive&#xD;
      symptoms among older adults with chronic heart failure. Meanwhile, the effect on cardiac&#xD;
      function and quality of life will also be explored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression has been one of the emerging health concerns for older adults, especially for&#xD;
      those with chronic heart failure (CHF). It was about 4-5 times more prevalent among patients&#xD;
      with CHF than healthy population and independently associated with poor outcome of CHF. As&#xD;
      suggested in the clinical management guideline of CHF, it is imperative to create integrative&#xD;
      intervention for older adults with CHF, including timely detection and intervention, and&#xD;
      ultimately improving the clinical outcome of CHF. However, the approach appropriate for&#xD;
      depression intervention among Chinese older adults has yet been developed. This study aims to&#xD;
      explore the effectiveness of psycho-behavioral intervention on depression associated with&#xD;
      chronic heart failure in old age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2019</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>16 Item Quick Inventory of Depressive Symptomatology Self-Report Version</measure>
    <time_frame>between baseline and week 12</time_frame>
    <description>The primary outcome measure is the response rate of depression from baseline to week 12. The response rate was defined as a 50% or greater score reduction on 16 Item Quick Inventory of Depressive Symptomatology-Self-Report. The total score ranges from 0 to 27, with higher scores indicating more severe symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>16 Item Quick Inventory of Depressive Symptomatology Self-Report Version</measure>
    <time_frame>between baseline and week 1, 2, 4, 8, 24 and 36</time_frame>
    <description>The severity of depressive symptoms was measured with the 16 Item Quick Inventory of Depressive Symptomatology Self-Report Version. The score ranges from 0 to 27, with higher scores indicating more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>17-Item Hamilton Rating Scale for Depression</measure>
    <time_frame>between baseline and week 4, 8, 12, 24 and 36</time_frame>
    <description>The severity of depressive symptoms was measured with 17-Item Hamilton Rating Scale for Depression. The 17-item Hamilton Depression Rating Scale produces a total score ranging from 0 (not at all depressed) to 52 (severely depressed).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory II</measure>
    <time_frame>between baseline and week 1, 2, 4, 8, 12, 24 and 36</time_frame>
    <description>The Beck Depression Inventory II assesses the severity of depression and produces a total score ranging from 0 to 63, with higher scores indicating more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Depression Inventory-Self-Report</measure>
    <time_frame>between baseline and week 4, 8, 12, 24 and 36</time_frame>
    <description>The Geriatric Depression Inventory-Self-Report assesses the severity of depression and produces a total score ranging from 0 to 12, with higher scores indicating more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>amino-terminal fragment of pro-B-type natriuretic peptide (NT-ProBNP)</measure>
    <time_frame>between baseline and week 12, and between baseline and week 36</time_frame>
    <description>change of NT-ProBNP level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac function</measure>
    <time_frame>between baseline and week 12, and between baseline and week 36</time_frame>
    <description>change of ejection fraction as measured with ultrasound cardiogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minnesota living with heart failure questionnaire</measure>
    <time_frame>between baseline and week 4, 8, 12, 24 and 36</time_frame>
    <description>The health-related quality of life was measured by Minnesota Living with Heart Failure Questionnaire.The total score ranges from 0 to 105, with higher scores from best to worst health-related quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">236</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Interventional group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive guided psycho-behavioral intervention once a week for 8 weeks. After 8 weeks, the subjects will receive monthly psychological counseling for 7 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will receive usual care and be contacted as same frequent as the intervention group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psycho-behavioral intervention</intervention_name>
    <description>The psycho-behavioral intervention included 12-week weekly guided psychological intervention (8 modules of behavioral intervention) and 24-week monthly maintenance psychological support.</description>
    <arm_group_label>Interventional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. between 60 -85 years old.&#xD;
&#xD;
          2. male or female.&#xD;
&#xD;
          3. Diagnosis with depression as measured with PHQ-9 score of 5 and greater;&#xD;
&#xD;
          4. The subject is diagnosed with chronic heart failure according to their history,&#xD;
             symptoms, signs, and adjuvant examinations (eg,echocardiography), in line with the&#xD;
             diagnostic criteria for chronic heart failure presented in the China Heart Failure&#xD;
             Diagnosis and Treatment Guidelines, with NYHA (New York Heart Association) grade&#xD;
             II-III.&#xD;
&#xD;
          5. Reading and writing competency for completing the rating scales.&#xD;
&#xD;
          6. Sufficient physical condition, hearing and vision to ensure the completion of&#xD;
             psychological behavior intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently taking antidepressant drugs, and drug dose is unstable.&#xD;
&#xD;
          2. With is a serious risk of suicide, suicide attempts and suicidal behavior (HAMD17&#xD;
             score of 30 or above, or suicide subscale score of 3 and above，or suicide subscale&#xD;
             score of MINI of 6 or above).&#xD;
&#xD;
          3. Intact cognitive function with CSI-D score of less than 7.&#xD;
&#xD;
          4. Having other major mental disorders, including Alzheimer's disease, schizophrenia,&#xD;
             schizoaffective psychiatric disorders, delusional disorders, undefined psychotic&#xD;
             disorders, substance and alcohol abuse&#xD;
&#xD;
          5. Planned heart surgery within 9 months.&#xD;
&#xD;
          6. Unable to comply with psychological intervention due to serious physical conditions -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huali Wang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Institute of Mental Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Huali Wang, PhD</last_name>
    <phone>+86 010-82801983</phone>
    <email>huali_wang@bjmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ying Zhang</last_name>
    <email>zhangying0603@bjmu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianhua He, MD</last_name>
    </contact>
    <investigator>
      <last_name>Jianhua He, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jin Yi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yulan Liang</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Na Zhang, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beijing Chaoyang Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yongdong Hu</last_name>
    </contact>
    <investigator>
      <last_name>Yongdong Hu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beijing Chaoyang Third Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wanxin Ma</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Fengtai Tieying Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peiyun Sun</last_name>
    </contact>
    <investigator>
      <last_name>Peiyun Sun</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ning Li</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beijing Tiancun Community Health Center</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qingling Yang</last_name>
    </contact>
    <investigator>
      <last_name>Qingling Yang</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jing Sun</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chong Zhang</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yun Zhu</last_name>
    </contact>
    <investigator>
      <last_name>Yun Zhu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>April 5, 2019</last_update_submitted>
  <last_update_submitted_qc>April 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Huali Wang</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After the results of primary outcome are published, the individual participant data will only be shared anonymously based on request by email to study PI. The team using data should work with the study PI's team on data analysis and publications. The host project should be acknowledged in any submitted working paper, conference presentations and publications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>After the results of primary outcome are published. The data will be available for 2 years.</ipd_time_frame>
    <ipd_access_criteria>Those who are interested in the study should submit a synopsis of research plan for administrative approval by the study committee. Once the data sharing plan is approved by the study committee, the researcher should submit a IRB approval from host institution. When the IRB approval is received, the study committee will ask the data manager to transfer the data for further analysis.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT03233451/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03233451
org study id: 2016-1-4117
nct id: NCT03233451
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study aims to explore the effectiveness of psycho-behavioral intervention on depressive
      symptoms among older adults with chronic heart failure. Meanwhile, the effect on cardiac
      function and quality of life will also be explored.
Depression has been one of the emerging health concerns for older adults, especially for
      those with chronic heart failure (CHF). It was about 4-5 times more prevalent among patients
      with CHF than healthy population and independently associated with poor outcome of CHF. As
      suggested in the clinical management guideline of CHF, it is imperative to create integrative
      intervention for older adults with CHF, including timely detection and intervention, and
      ultimately improving the clinical outcome of CHF. However, the approach appropriate for
      depression intervention among Chinese older adults has yet been developed. This study aims to
      explore the effectiveness of psycho-behavioral intervention on depression associated with
      chronic heart failure in old age.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: 16 Item Quick Inventory of Depressive Symptomatology Self-Report Version
time frame: between baseline and week 12
description: The primary outcome measure is the response rate of depression from baseline to week 12. The response rate was defined as a 50% or greater score reduction on 16 Item Quick Inventory of Depressive Symptomatology-Self-Report. The total score ranges from 0 to 27, with higher scores indicating more severe symptoms.
measure: 16 Item Quick Inventory of Depressive Symptomatology Self-Report Version
time frame: between baseline and week 1, 2, 4, 8, 24 and 36
description: The severity of depressive symptoms was measured with the 16 Item Quick Inventory of Depressive Symptomatology Self-Report Version. The score ranges from 0 to 27, with higher scores indicating more severe symptoms.
measure: 17-Item Hamilton Rating Scale for Depression
time frame: between baseline and week 4, 8, 12, 24 and 36
description: The severity of depressive symptoms was measured with 17-Item Hamilton Rating Scale for Depression. The 17-item Hamilton Depression Rating Scale produces a total score ranging from 0 (not at all depressed) to 52 (severely depressed).
measure: Beck Depression Inventory II
time frame: between baseline and week 1, 2, 4, 8, 12, 24 and 36
description: The Beck Depression Inventory II assesses the severity of depression and produces a total score ranging from 0 to 63, with higher scores indicating more severe symptoms.
measure: Geriatric Depression Inventory-Self-Report
time frame: between baseline and week 4, 8, 12, 24 and 36
description: The Geriatric Depression Inventory-Self-Report assesses the severity of depression and produces a total score ranging from 0 to 12, with higher scores indicating more severe symptoms.
measure: amino-terminal fragment of pro-B-type natriuretic peptide (NT-ProBNP)
time frame: between baseline and week 12, and between baseline and week 36
description: change of NT-ProBNP level
measure: cardiac function
time frame: between baseline and week 12, and between baseline and week 36
description: change of ejection fraction as measured with ultrasound cardiogram
measure: Minnesota living with heart failure questionnaire
time frame: between baseline and week 4, 8, 12, 24 and 36
description: The health-related quality of life was measured by Minnesota Living with Heart Failure Questionnaire.The total score ranges from 0 to 105, with higher scores from best to worst health-related quality of life.
arm group label: Interventional group
arm group type: Experimental
description: Subjects receive guided psycho-behavioral intervention once a week for 8 weeks. After 8 weeks, the subjects will receive monthly psychological counseling for 7 months.
arm group label: control group
arm group type: No Intervention
description: Subjects will receive usual care and be contacted as same frequent as the intervention group.
intervention type: Behavioral
intervention name: Psycho-behavioral intervention
description: The psycho-behavioral intervention included 12-week weekly guided psychological intervention (8 modules of behavioral intervention) and 24-week monthly maintenance psychological support.
arm group label: Interventional group
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: No
last name: Huali Wang, PhD
role: Principal Investigator
affiliation: Peking University Institute of Mental Health
last name: Huali Wang, PhD
phone: +86 010-82801983
email: huali_wang@bjmu.edu.cn
last name: Ying Zhang
email: zhangying0603@bjmu.edu.cn
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Huali Wang
investigator title: Principal Investigator
mesh term: Heart Failure
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: Yes
ipd description: After the results of primary outcome are published, the individual participant data will only be shared anonymously based on request by email to study PI. The team using data should work with the study PI's team on data analysis and publications. The host project should be acknowledged in any submitted working paper, conference presentations and publications.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: After the results of primary outcome are published. The data will be available for 2 years.
ipd access criteria: Those who are interested in the study should submit a synopsis of research plan for administrative approval by the study committee. Once the data sharing plan is approved by the study committee, the researcher should submit a IRB approval from host institution. When the IRB approval is received, the study committee will ask the data manager to transfer the data for further analysis.
provided document: 