Assessment of Somatic Symptom Burden

March 6, 2024 updated by: RenJi Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jialiang Mao, MD
  • Phone Number: 68383477 13311606283
  • Email: maoji@aliyun.com

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200127
        • Recruiting
        • RenJi Hospital
        • Contact:
        • Contact:
          • Bingxu Chen, postgraduate
          • Phone Number: 15800539513
          • Email: zhyp0818@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • SSS-CN and PHQ-15 questionnaire
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
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.
Other Names:
  • SSS-CN and PHQ-15 questionnaire before coronary angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The score of the SSS-CN in the general population
Time Frame: Within 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).
Within 24 hours after collecting the scale.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with somatic burden in suspected CAD patients
Time Frame: Within 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.
Within 24 hours after the coronary angiography.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

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

Investigators

  • Study Chair: Meng Jiang, MD, RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 3, 2017

First Submitted That Met QC Criteria

October 22, 2017

First Posted (Actual)

October 25, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSS201709

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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