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

Shanghai Mental Health Center

Status: Unknown

Conditions: Depression

Study type: Observational

Funder types: Other

Identifiers

NCT04500379

2020-52

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.