Assessment of Somatic Symptom Burden

Recruiting

• Conditions: Somatization Disorder
• Interventions: Diagnostic Test: The general population; Diagnostic Test: Patients with suspected CAD

• Registration Number: NCT03321409
• Lead Sponsor: RenJi Hospital

Brief Summary

The Patient Health Questionnaire-15 (PHQ-15) is a frequently used questionnaire to assess somatic symptom burden. The Somatic Symptom Scale China (SSS-CN) was recently developed as a comprehensive self-report instrument in assessing somatic symptom burden, but its assessment value has not yet been widely tested in a nationwide. The study aims to investigate the reliability of the SSS-CN, to validate discriminate validity and factorial validity, and to investigate its utility in patients with suspected coronary artery disease (CAD) based on multi-centers inpatients.

Detailed Description

Somatic symptoms are prevalent in kinds of medical conditions and mental disorders. Since they are associated with decreased quality of life, increased psychological distress, and increased use of health care services, the assessment of somatic symptom burden is essential in evidence based patient care and research. The Patient Health Questionnaire-15 (PHQ-15) is a frequently used questionnaire to assess somatic symptom burden, but in which there are not any mental symptoms listed. Recently, we developed the Somatic Symptom Scale China (SSS-CN) which includes common mental symptoms and more comprehensive somatic symptoms to assess somatic symptom burden, but its assessment value has not yet been widely tested.

The aim of our study is to investigate the reliability and validity of the SSS-CN compared with the PHQ-15. We also try to use the SSS-CN to investigate the prevalence of somatic symptoms in patients with suspected coronary artery disease (CAD) based on multi-centers inpatients.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-22
• Study First Posted: 2017-10-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. People who take the physical examination in Renji Hospital.
2. Patients with suspected CAD.

Exclusion Criteria

1. People who have been previously confirmed serious medical conditions.
2. People who have been previously confirmed serious mental disorders.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The general population	The general population	People who take the physical examination in Renji Hospital between 18 to 80 years old without any previously confirmed serious medical conditions or mental disorders.
The patients with suspected CAD	Patients with suspected CAD	Patients with suspected CAD between 18 to 80 years old without any previously confirmed serious medical conditions or mental disorders.

Primary Outcome Measures

Name	Time	Method
The score of the SSS-CN in the general population	Within 24 hours after collecting the scale.	To investigate the cutoff, reliability and validity of the SSS-CN according to the score.; The Somatic Symptom Scale China (SSS-CN) is developed to assess somatic symptom burden, which includes 20 items. Each item represents an organ discomfort and is rated as 1 ("not at all"), 2 （"mild"）, 3（"moderate"）， or 4 ("severe"). In determining the SSS-CN score, the total score is summarized from the 20 items, rendering ranges from 20 to 80 (higher scores represent the more severe somatic symptom burden).

Secondary Outcome Measures

Name	Time	Method
Number of participants with somatic burden in suspected CAD patients	Within 24 hours after the coronary angiography.	To validate the utility of SSS-CN and investigate the prevalence of somatic burden in patients with suspected CAD as assessed by SSS-CN.

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, China