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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
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03321409
Enrollment
2000
Registered
2017-10-25
Start date
2017-09-01
Completion date
2025-06-01
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Somatization Disorder

Keywords

Somatic symptom, SSS-CN, PHQ-15, Suspected CAD, Coronary angiography

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.

Interventions

DIAGNOSTIC_TESTThe 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_TESTPatients 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.

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Peking University People's Hospital
CollaboratorOTHER
The First Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The score of the SSS-CN in the general populationWithin 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

MeasureTime frameDescription
Number of participants with somatic burden in suspected CAD patientsWithin 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.

Countries

China

Contacts

Primary ContactMeng Jiang, MD
jiangmeng0919@163.com13788912766
Backup ContactJialiang Mao, MD
maoji@aliyun.com13311606283

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026