<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/NCT04500379</url>
  </required_header>
  <id_info>
    <org_study_id>2020-52</org_study_id>
    <nct_id>NCT04500379</nct_id>
  </id_info>
  <brief_title>Reliability and Validity of FIBSER, STAR-P, HEA Scale The Reliability and Validity of Chinese Version of FIBSER, STAR-P, HEA Scale in Depression Assessment</brief_title>
  <official_title>The Reliability and Validity of Chinese Version of FIBSER, STAR-P, HEA Scale in Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Mental Health Center</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>
      According to the survey of the World Health Organization, the number of patients with&#xD;
      depression in the world has reached 350 million, has becoming the primary cause of disability&#xD;
      and the main disease burden worldwide. In order to better dealing with adverse reactions,&#xD;
      improving the doctor-patient relationship and optimizing the treatment cost, FIBSER, STAR-P&#xD;
      and HEA Health Economics Follow-up Evaluation Scale are selected as simple and quick&#xD;
      evaluation scales to evaluate the influence, doctor-patient relationship and social and&#xD;
      economic benefits after drug treatment in clinical treatment. At present, the reliability and&#xD;
      validity of FIBSER, STAR-P and HEA scales will be verified the reliability and validity of&#xD;
      the above three scales in depressive disorder, aiming at enriching the treatment of&#xD;
      depressive patients based on assessment, thus improving the compliance of medication for&#xD;
      depressive disorder, improving the doctor-patient relationship and reducing the total burden&#xD;
      of social diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the reliability and validity of FIBSER Scale, Doctor-patient Relationship&#xD;
      Scale-Patient Edition (STAR-P) and HEA in Chinese population will be verified to increase the&#xD;
      diversity and selectivity of domestic assessment tools.&#xD;
&#xD;
      This study includes two steps.&#xD;
&#xD;
        1. baseline: demographic data, HAM-D, HAM-A, YMRS, drug side effects scale：FIBSER, TESS；&#xD;
           doctor-patient relationship scale ：STAR-P, PDRQ-15；Health economics follow-up evaluation&#xD;
           scale ：SDS and HEA were evaluated.&#xD;
&#xD;
        2. follow-up (4 weeks): HAM-D, HAM-A, YMRS, FIBSER, STAR-P and HEA scale in order to verify&#xD;
           the reliability of retest.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 24, 2020</start_date>
  <completion_date type="Anticipated">December 28, 2022</completion_date>
  <primary_completion_date type="Actual">October 5, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment Emergent Symptom Scale TESS</measure>
    <time_frame>Up to 1 week</time_frame>
    <description>Common adverse drug reactions and signs were evaluated. The &quot;severity&quot; column was used to evaluate the severity level of symptoms from 0 to 4. The higher the severity level, the more serious the symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Frequency, Intensity, and Burden of Side Effects Rating, FIBSER</measure>
    <time_frame>Up to 4 week</time_frame>
    <description>Evaluate three areas of drug side effects through patient self-report and rank the drug impact: frequency (how many adverse reactions caused by depression drugs in the past week), intensity (how serious adverse reactions caused by depression drugs in the past week), and burden (how much adverse reactions caused by depression drugs affect your daily activities in the past week).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HEA Health Economics Follow-up Evaluation Form，HEA</measure>
    <time_frame>Up to 4 week</time_frame>
    <description>The main evaluation in the past month includes the following items: how many times have you seen a doctor (doctor), other medical personnel, whether you have been in hospital, and the number of days off due to depression and other diseases</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sheehan Disability Scale ，SDS</measure>
    <time_frame>Up to 1 week</time_frame>
    <description>Including three items, ask patients about the degree of damage caused by their current diseases/symptoms to their work, social interaction and family functions in turn; Visual simulation score of 0-10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Doctor-patient Relationship Scale-Patient Edition ，STAR-P Doctor-patient Relationship Scale-Patient Edition (STAR-P)</measure>
    <time_frame>Up to 4 week</time_frame>
    <description>The total score of STAR-P and the scores of three subscales are adopted: active collaboration (PCO: harmonious and shared understanding of goals and mutual open and trusted experiences), active clinician input (PCI: clinicians encourage, consider, support, listen and understand patients) and non-clinician input (NCI: patients can't understand clinicians), which is composed of 12 items</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PDRQ-15 Scale</measure>
    <time_frame>Up to 1 week</time_frame>
    <description>There are 15 items in total, which are divided into three dimensions: patient/family satisfaction (6 items), accessibility of medical staff (7 items) and disease attitude of patients/family members.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HAM-D</measure>
    <time_frame>Up to 4 week</time_frame>
    <description>To evaluate the severity of depressive symptoms by clinicians. Remission: total score &lt; 7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAM-A</measure>
    <time_frame>Up to 4 week</time_frame>
    <description>To evaluate the severity of anxiety symptoms by clinicians. The total score &lt; 6: no anxiety sympotom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>YMRS</measure>
    <time_frame>Up to 4 week</time_frame>
    <description>Assess symptoms of mania,the total score &lt; 6: no mania sympotom.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Depression</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Depressive disorder group: The samples were from the outpatients and inpatients of Shanghai&#xD;
        Mental Health Center and Shanghai Pudong New Area Mental Health Center from January 2020 to&#xD;
        December 2020, and met DSM-5 diagnostic criteria. Sixty patients aged 1865 were enrolled in&#xD;
        the group.&#xD;
&#xD;
        Healthy control group: The sample comes from the healthy people recruited by the society&#xD;
        who meet the entry criteria of the control group and match the gender, age and education&#xD;
        level, and 60 cases are planned to be enrolled in the group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Case group:&#xD;
&#xD;
               1. The subjects were psychiatric outpatients and inpatients who were able and&#xD;
                  willing to provide informed consent.&#xD;
&#xD;
               2. Men or women aged between 18 and 65, with junior high school education or above.&#xD;
&#xD;
               3. according to DSM-5 criteria, patients diagnosed with depressive disorder.&#xD;
&#xD;
               4. The total score of Hamilton Depression Scale (HAM-D) was ≥7 and the total score&#xD;
                  of Young Mania Scale (YMRS) was ≤5.&#xD;
&#xD;
               5. subjects were treated with antidepressants at least two weeks before the study&#xD;
                  visit, all of them were SSRIs.&#xD;
&#xD;
        Control group:&#xD;
&#xD;
        1）did not meet the diagnostic criteria of any axis I in DSM-5. 2）18-65 years old, with&#xD;
        junior high school education or above. 3）Willing to participate in this study, and the&#xD;
        subjects signed the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - 1）severe drug allergy. 2）Suffering from some serious physical diseases adversely affects&#xD;
        the validity of neuropsychological test data.&#xD;
&#xD;
        3）serious negative suicide concept.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun Chen, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Mental Health Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jun Chen, M.D., Ph.D</last_name>
    <phone>021-34773367</phone>
    <email>doctorcj2010@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yousong Su, Master</last_name>
    <phone>13788929029</phone>
    <email>wintersus@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai Mental Health Center IRB</name>
      <address>
        <city>Shanghai</city>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Chen, M.D., Ph.D</last_name>
      <phone>021-34773367</phone>
      <email>doctorcj2010@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>September 22, 2022</last_update_submitted>
  <last_update_submitted_qc>September 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>FIBSER</keyword>
  <keyword>STAR-P</keyword>
  <keyword>HEA scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT04500379
org study id: 2020-52
nct id: NCT04500379
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
According to the survey of the World Health Organization, the number of patients with
      depression in the world has reached 350 million, has becoming the primary cause of disability
      and the main disease burden worldwide. In order to better dealing with adverse reactions,
      improving the doctor-patient relationship and optimizing the treatment cost, FIBSER, STAR-P
      and HEA Health Economics Follow-up Evaluation Scale are selected as simple and quick
      evaluation scales to evaluate the influence, doctor-patient relationship and social and
      economic benefits after drug treatment in clinical treatment. At present, the reliability and
      validity of FIBSER, STAR-P and HEA scales will be verified the reliability and validity of
      the above three scales in depressive disorder, aiming at enriching the treatment of
      depressive patients based on assessment, thus improving the compliance of medication for
      depressive disorder, improving the doctor-patient relationship and reducing the total burden
      of social diseases.
In this study, the reliability and validity of FIBSER Scale, Doctor-patient Relationship
      Scale-Patient Edition (STAR-P) and HEA in Chinese population will be verified to increase the
      diversity and selectivity of domestic assessment tools.

      This study includes two steps.

        1. baseline: demographic data, HAM-D, HAM-A, YMRS, drug side effects scale：FIBSER, TESS；
           doctor-patient relationship scale ：STAR-P, PDRQ-15；Health economics follow-up evaluation
           scale ：SDS and HEA were evaluated.

        2. follow-up (4 weeks): HAM-D, HAM-A, YMRS, FIBSER, STAR-P and HEA scale in order to verify
           the reliability of retest.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Treatment Emergent Symptom Scale TESS
time frame: Up to 1 week
description: Common adverse drug reactions and signs were evaluated. The "severity" column was used to evaluate the severity level of symptoms from 0 to 4. The higher the severity level, the more serious the symptoms
measure: The Frequency, Intensity, and Burden of Side Effects Rating, FIBSER
time frame: Up to 4 week
description: Evaluate three areas of drug side effects through patient self-report and rank the drug impact: frequency (how many adverse reactions caused by depression drugs in the past week), intensity (how serious adverse reactions caused by depression drugs in the past week), and burden (how much adverse reactions caused by depression drugs affect your daily activities in the past week).
measure: HEA Health Economics Follow-up Evaluation Form，HEA
time frame: Up to 4 week
description: The main evaluation in the past month includes the following items: how many times have you seen a doctor (doctor), other medical personnel, whether you have been in hospital, and the number of days off due to depression and other diseases
measure: Sheehan Disability Scale ，SDS
time frame: Up to 1 week
description: Including three items, ask patients about the degree of damage caused by their current diseases/symptoms to their work, social interaction and family functions in turn; Visual simulation score of 0-10
measure: Doctor-patient Relationship Scale-Patient Edition ，STAR-P Doctor-patient Relationship Scale-Patient Edition (STAR-P)
time frame: Up to 4 week
description: The total score of STAR-P and the scores of three subscales are adopted: active collaboration (PCO: harmonious and shared understanding of goals and mutual open and trusted experiences), active clinician input (PCI: clinicians encourage, consider, support, listen and understand patients) and non-clinician input (NCI: patients can't understand clinicians), which is composed of 12 items
measure: PDRQ-15 Scale
time frame: Up to 1 week
description: There are 15 items in total, which are divided into three dimensions: patient/family satisfaction (6 items), accessibility of medical staff (7 items) and disease attitude of patients/family members.
measure: HAM-D
time frame: Up to 4 week
description: To evaluate the severity of depressive symptoms by clinicians. Remission: total score < 7.
measure: HAM-A
time frame: Up to 4 week
description: To evaluate the severity of anxiety symptoms by clinicians. The total score < 6: no anxiety sympotom.
measure: YMRS
time frame: Up to 4 week
description: Assess symptoms of mania,the total score < 6: no mania sympotom.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jun Chen, M.D., Ph.D
role: Principal Investigator
affiliation: Shanghai Mental Health Center
last name: Jun Chen, M.D., Ph.D
phone: 021-34773367
email: doctorcj2010@gmail.com
last name: Yousong Su, Master
phone: 13788929029
email: wintersus@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder