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

The Reliability and Validity of Chinese Version of FIBSER, STAR-P, HEA Scale in Depression

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.

Study Overview

• Status: Recruiting
• Conditions: Depression

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Yousong Su, Master; Phone Number: 13788929029; Email: wintersus@126.com

Study Locations

• China
  • Shanghai, China, 200030
    • Recruiting
    • Shanghai Mental Health Center IRB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Principal Investigator: Jun Chen, M.D., Ph.D, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2020
• Primary Completion (Actual): October 5, 2021
• Study Completion (Anticipated): December 28, 2022

Study Registration Dates

• First Submitted: August 2, 2020
• First Submitted That Met QC Criteria: August 2, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: FIBSER; STAR-P; HEA scale
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 2020-52

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No