<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/NCT04469608</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH109-REC3-041</org_study_id>
    <nct_id>NCT04469608</nct_id>
  </id_info>
  <brief_title>Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients</brief_title>
  <official_title>Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University Hospital</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 teaching platform of the TCM daycare clinics for depression patients will provide a good&#xD;
      clinical training environment for the trainees. They can learn how to take care of depression&#xD;
      patients by the lectures and the clinical practice experiences in the daycare clinics. They&#xD;
      can also learn a holistic approach, a patient-centered healthcare service. This teaching&#xD;
      model will strengthen the clinical training of TCM and enhance the international&#xD;
      competitiveness of TCM doctors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Major depressive disorder (MDD) is a serious psychiatric illness with a high lifetime&#xD;
      prevalence rate and causes major clinical, social and economic burden to patients and their&#xD;
      family. Despite that more than 40 antidepressants with various mechanisms are available on&#xD;
      the market, half of patients fail to achieve remission with optimized medication treatment&#xD;
      because of unsatisfactory efficacy, frequent intolerability and poor compliance of&#xD;
      pharmacotherapies. However, Traditional Chinese medicine (TCM) is a safe and effective&#xD;
      therapy which has many previous evidences to improve the treatment of depression. The aim of&#xD;
      this project is to build up a TCM clinical daycare model for depression patients, and to&#xD;
      establish a teaching platform for TCM trainees.&#xD;
&#xD;
      The TCM daycare model will be provided by a team organized by doctors, nurses, pharmacists,&#xD;
      psychologist, nutritionist and case managers. This model will provide a comprehensive TCM&#xD;
      care system to improve the clinical symptoms and quality of life of depression patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">May 11, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hamilton Depression Rating Scale, HAM-D</measure>
    <time_frame>Start of treatment (day 0) and end of treatment (week 8)</time_frame>
    <description>Each question of HAM-D is rated 3-5 points, eight questions are 0-2 points, nine questions are 0-4 points, and the total score is 0-52 points. Evaluate the emotional and physical and mental states observed in the case during the most recent week and interview.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory(BDI)</measure>
    <time_frame>Start of treatment (day 0) and end of treatment (week 8)</time_frame>
    <description>Beck Depression Inventory assesses the degree of depression of 13-80 year olds, as a diagnosis and treatment reference</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pittsburgh Sleep Quality Inventory</measure>
    <time_frame>Start of treatment (day 0) and end of treatment (week 8)</time_frame>
    <description>It is suitable for the evaluation of sleep quality in patients with sleep disorders and mental disorders, and is also suitable for the evaluation of sleep quality in ordinary people.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WHOQOL-Taiwan</measure>
    <time_frame>Start of treatment (day 0) and end of treatment (week 8)</time_frame>
    <description>Four-dimension: Physiology + Independence; Psychology + Spirituality/Religion/Personal Belief;</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Traditional Chinese Medicine</condition>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>TCM clinical daycare model for depression patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tai Chi and Acupuncture and Yoga and Mindfulness</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Depression patients</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Tai Chi and acupuncture and yoga and mindfulness are not added</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>Traditional Chinese medicine clinical daycare</description>
    <arm_group_label>TCM clinical daycare model for depression patients</arm_group_label>
    <other_name>yoga</other_name>
    <other_name>mindfulness</other_name>
    <other_name>Tai Chi</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of depression according to DSM-IV (Diagnosis code: 296.21-296.30, 300.4)&#xD;
&#xD;
          2. Age 18-65 years, male or female&#xD;
&#xD;
          3. Evaluation of the 21-item Hamilton Rating Scale for Depression (HAMD) 8 points or more&#xD;
&#xD;
          4. Fully understand the entire research plan and sign the informed consent form (aged&#xD;
             18-20 years old must be jointly signed by a legal agent)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have a diagnosis of mental illness other than depression in the last or past 6 months,&#xD;
             including unipolar major depression, including dyslexia, organic mental disorder,&#xD;
             impulse control disorder, substance use disorder, bipolar mental disorder or substance&#xD;
             abuse.&#xD;
&#xD;
          2. Medical history of patients diagnosed with borderline, antisocial personality disorder&#xD;
&#xD;
          3. Take anti-psychotic disorders and anti-epileptic drugs in the past six months.&#xD;
&#xD;
          4. Have or may become pregnant&#xD;
&#xD;
          5. A person with serious suicidal ideation or suicide attempt who must be hospitalized&#xD;
             for close monitoring&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu-Chen Lee</last_name>
    <role>Study Director</role>
    <affiliation>Department of Acupuncture, China Medical University Hospital Taichung, Taiwan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Acupuncture, China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</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>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</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/NCT04469608
org study id: CMUH109-REC3-041
nct id: NCT04469608
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The teaching platform of the TCM daycare clinics for depression patients will provide a good
      clinical training environment for the trainees. They can learn how to take care of depression
      patients by the lectures and the clinical practice experiences in the daycare clinics. They
      can also learn a holistic approach, a patient-centered healthcare service. This teaching
      model will strengthen the clinical training of TCM and enhance the international
      competitiveness of TCM doctors.
Major depressive disorder (MDD) is a serious psychiatric illness with a high lifetime
      prevalence rate and causes major clinical, social and economic burden to patients and their
      family. Despite that more than 40 antidepressants with various mechanisms are available on
      the market, half of patients fail to achieve remission with optimized medication treatment
      because of unsatisfactory efficacy, frequent intolerability and poor compliance of
      pharmacotherapies. However, Traditional Chinese medicine (TCM) is a safe and effective
      therapy which has many previous evidences to improve the treatment of depression. The aim of
      this project is to build up a TCM clinical daycare model for depression patients, and to
      establish a teaching platform for TCM trainees.

      The TCM daycare model will be provided by a team organized by doctors, nurses, pharmacists,
      psychologist, nutritionist and case managers. This model will provide a comprehensive TCM
      care system to improve the clinical symptoms and quality of life of depression patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hamilton Depression Rating Scale, HAM-D
time frame: Start of treatment (day 0) and end of treatment (week 8)
description: Each question of HAM-D is rated 3-5 points, eight questions are 0-2 points, nine questions are 0-4 points, and the total score is 0-52 points. Evaluate the emotional and physical and mental states observed in the case during the most recent week and interview.
measure: Beck Depression Inventory(BDI)
time frame: Start of treatment (day 0) and end of treatment (week 8)
description: Beck Depression Inventory assesses the degree of depression of 13-80 year olds, as a diagnosis and treatment reference
measure: Pittsburgh Sleep Quality Inventory
time frame: Start of treatment (day 0) and end of treatment (week 8)
description: It is suitable for the evaluation of sleep quality in patients with sleep disorders and mental disorders, and is also suitable for the evaluation of sleep quality in ordinary people.
measure: WHOQOL-Taiwan
time frame: Start of treatment (day 0) and end of treatment (week 8)
description: Four-dimension: Physiology + Independence; Psychology + Spirituality/Religion/Personal Belief;
arm group label: TCM clinical daycare model for depression patients
arm group type: Experimental
description: Tai Chi and Acupuncture and Yoga and Mindfulness
arm group label: Depression patients
arm group type: No Intervention
description: Tai Chi and acupuncture and yoga and mindfulness are not added
intervention type: Behavioral
intervention name: acupuncture
description: Traditional Chinese medicine clinical daycare
arm group label: TCM clinical daycare model for depression patients
other name: yoga
other name: mindfulness
other name: Tai Chi
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yu-Chen Lee
role: Study Director
affiliation: Department of Acupuncture, China Medical University Hospital Taichung, Taiwan
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
sharing ipd: No