Assessment of Somatic Symptom Burden

NCT03321409 | Recruiting

• 1 other identifier: SSS201709
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Somatization Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with somatic burden in suspected CAD patients

  Within 24 hours after the coronary angiography.

Study Arms (2)

The general population

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.

Diagnostic Test: The general population

The patients with suspected CAD

Patients with suspected CAD between 18 to 80 years old without any previously confirmed serious medical conditions or mental disorders.

Diagnostic Test: Patients with suspected CAD

Interventions

The general population DIAGNOSTIC_TEST

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.

Also known as: SSS-CN and PHQ-15 questionnaire

The general population

Patients with suspected CAD DIAGNOSTIC_TEST

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.

Also known as: SSS-CN and PHQ-15 questionnaire before coronary angiography

The patients with suspected CAD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• People who take the physical examination in Renji Hospital.
• Patients with suspected CAD.

You may not qualify if:

• People who have been previously confirmed serious medical conditions.
• People who have been previously confirmed serious mental disorders.

Sponsors & Collaborators

• RenJi Hospital: lead
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Peking University People's Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (1)

Renji Hospital

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Somatoform Disorders; Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Meng Jiang, MD

  RenJi Hospital

  STUDY CHAIR

Central Study Contacts

Meng Jiang, MD

CONTACT

13788912766; jiangmeng0919@163.com

Jialiang Mao, MD

CONTACT

13311606283; maoji@aliyun.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 25, 2017
• Study Start: September 1, 2017
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

CN (1)