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

• Conditions: Depression

• Registration Number: NCT04500379
• Lead Sponsor: Shanghai Mental Health Center

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.

Study Timeline

• Study Start: 2020-07-24
• Study First Submitted: 2020-08-02
• Study First Submitted QC: 2020-08-02
• Study First Posted: 2020-08-05
• Status Verified: 2021-09
• Primary Completion: 2021-10-05
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-23
• Study Completion: 2022-12-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment Emergent Symptom Scale TESS	Up to 1 week	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
The Frequency, Intensity, and Burden of Side Effects Rating, FIBSER	Up to 4 week	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).
HEA Health Economics Follow-up Evaluation Form，HEA	Up to 4 week	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
Sheehan Disability Scale ，SDS	Up to 1 week	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
Doctor-patient Relationship Scale-Patient Edition ，STAR-P Doctor-patient Relationship Scale-Patient Edition (STAR-P)	Up to 4 week	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
PDRQ-15 Scale	Up to 1 week	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.

Secondary Outcome Measures

Name	Time	Method
HAM-D	Up to 4 week	To evaluate the severity of depressive symptoms by clinicians. Remission: total score \< 7.
HAM-A	Up to 4 week	To evaluate the severity of anxiety symptoms by clinicians. The total score \< 6: no anxiety sympotom.
YMRS	Up to 4 week	Assess symptoms of mania,the total score \< 6: no mania sympotom.

Trial Locations

Locations (1)

Shanghai Mental Health Center IRB; 🇨🇳 Shanghai, China