NCT03321409

Assessment of Somatic Symptom Burden

The Validation of the Somatic Symptom Scale China (SSS-CN) for Assessing Somatic Symptom Burden and Its Utility in Patients With Suspected Coronary Artery Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Somatization Disorder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	The general population	After recruiting participants, collecting the baseline data, the SSS-CN and PHQ-15 will be carried out. Then validating the reliability, validity of the SSS-CN will be compared with the PHQ-15.
DIAGNOSTIC_TEST	Patients with suspected CAD	In patients with suspected CAD, after recruiting participants, collecting the baseline data, the SSS-CN and PHQ-15 will be carried out before undergo coronary angiography. Then the prevalence of somatic symptoms will be investigated.

Timeline

• Start date: 2017-09-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2017-10-25
• Last updated: 2024-03-07

Locations

1 site across 1 country: China