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Assessment of Somatic Symptom Burden

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Somatization Disorder

Treatments

Diagnostic Test: The general population
Diagnostic Test: Patients with suspected CAD

Study type

Observational

Funder types

Other

Identifiers

NCT03321409
SSS201709

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

2,000 participants in 2 patient groups

The general population
Description:
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.
Treatment:
Diagnostic Test: The general population
The patients with suspected CAD
Description:
Patients with suspected CAD between 18 to 80 years old without any previously confirmed serious medical conditions or mental disorders.
Treatment:
Diagnostic Test: Patients with suspected CAD

Trial contacts and locations

1

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Central trial contact

Meng Jiang, MD; Jialiang Mao, MD

Data sourced from clinicaltrials.gov

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