Assessment of Somatic Symptom Burden

NCT ID: NCT03321409

Last Updated: 2024-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2025-06-01

Brief Summary

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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

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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.

Conditions

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Somatization Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

The general population

Intervention Type 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.

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.

Patients with suspected CAD

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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SSS-CN and PHQ-15 questionnaire SSS-CN and PHQ-15 questionnaire before coronary angiography

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meng Jiang, MD

Role: STUDY_CHAIR

RenJi Hospital

Locations

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Renji Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Meng Jiang, MD

Role: CONTACT

13788912766 ext. 58752445

Jialiang Mao, MD

Role: CONTACT

13311606283 ext. 68383477

Facility Contacts

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Xuan Su, postgraduate

Role: primary

18817560226 ext. 68385925

Bingxu Chen, postgraduate

Role: backup

15800539513

Other Identifiers

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SSS201709

Identifier Type: -

Identifier Source: org_study_id

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