Clinical trial NCT03321409: Assessment of Somatic Symptom Burden
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Somatization Disorder
Keywords: Somatic symptom
SSS-CN
PHQ-15
Suspected CAD
Coronary angiography
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Peking University People's Hospital
name: The First Affiliated Hospital of Zhengzhou University
First posted: 2017-10-25
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive subjects are enrolled into 2 cohorts between September 2017 and June 2019. The cohorts are divided as the general population and the patients with suspected CAD.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The score of the SSS-CN in the general population
timeFrame: Within 24 hours after collecting the scale.
Secondary outcomes:
measure: Number of participants with somatic burden in suspected CAD patients
timeFrame: Within 24 hours after the coronary angiography.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
affiliation: RenJi Hospital
name: Meng Jiang, MD
role: STUDY_CHAIR
References: