Clinical trial NCT04500379: 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
Official title: The Reliability and Validity of Chinese Version of FIBSER, STAR-P, HEA Scale in Depression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depression
Keywords: FIBSER
STAR-P
HEA scale
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Depressive disorder group: The samples were from the outpatients and inpatients of Shanghai Mental Health Center and Shanghai Pudong New Area Mental Health Center from January 2020 to December 2020, and met DSM-5 diagnostic criteria. Sixty patients aged 1865 were enrolled in the group.

Healthy control group: The sample comes from the healthy people recruited by the society who meet the entry criteria of the control group and match the gender, age and education level, and 60 cases are planned to be enrolled in the group.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Case group:

  1. The subjects were psychiatric outpatients and inpatients who were able and willing to provide informed consent.
  2. Men or women aged between 18 and 65, with junior high school education or above.
  3. according to DSM-5 criteria, patients diagnosed with depressive disorder.
  4. The total score of Hamilton Depression Scale (HAM-D) was ≥7 and the total score of Young Mania Scale (YMRS) was ≤5.
  5. subjects were treated with antidepressants at least two weeks before the study visit, all of them were SSRIs.

Control group:

1）did not meet the diagnostic criteria of any axis I in DSM-5. 2）18-65 years old, with junior high school education or above. 3）Willing to participate in this study, and the subjects signed the informed consent form.

Exclusion Criteria:

- 1）severe drug allergy. 2）Suffering from some serious physical diseases adversely affects the validity of neuropsychological test data.

3）serious negative suicide concept.

Primary outcomes:
measure: Treatment Emergent Symptom Scale TESS
timeFrame: Up to 1 week
measure: The Frequency, Intensity, and Burden of Side Effects Rating, FIBSER
timeFrame: Up to 4 week
measure: HEA Health Economics Follow-up Evaluation Form，HEA
timeFrame: Up to 4 week
measure: Sheehan Disability Scale ，SDS
timeFrame: Up to 1 week
measure: Doctor-patient Relationship Scale-Patient Edition ，STAR-P Doctor-patient Relationship Scale-Patient Edition (STAR-P)
timeFrame: Up to 4 week
measure: PDRQ-15 Scale
timeFrame: Up to 1 week
Secondary outcomes:
measure: HAM-D
timeFrame: Up to 4 week
measure: HAM-A
timeFrame: Up to 4 week
measure: YMRS
timeFrame: Up to 4 week
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center IRB
Study officials:
affiliation: Shanghai Mental Health Center
name: Jun Chen, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: