Assessment of Somatic Symptom Burden

Somatization Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03321409
• Other study ID #: SSS201709
• Status: Recruiting
• Start date: September 1, 2017
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: RenJi Hospital
• Contact: Meng Jiang, MD
• Phone: 13788912766
• Email: jiangmeng0919[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Medically Unexplained Symptoms
• Somatization Disorder
• Somatoform Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai

Sponsors (4)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The score of the SSS-CN in the general population	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).	Within 24 hours after collecting the scale.
Secondary	Number of participants with somatic burden in suspected CAD patients	To validate the utility of SSS-CN and investigate the prevalence of somatic burden in patients with suspected CAD as assessed by SSS-CN.	Within 24 hours after the coronary angiography.