- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04815863
Assessment of Somatic Symptom in Chinese Community-Dwelling People
A Comparison of Somatic Symptom Among Elderly and Non-elderly in Chinese Community-Dwelling People
Study Overview
Status
Conditions
Detailed Description
With the steadily increasing of life expectancy, the aging people is expected to 2 billion by 2050, which brings the deeper demand on the quality of life improvement. The psychological problems is an important factor affecting the quality of life. As reported, 73.6% of urban residents were with mental sub-health, indicating that psychological problem has grown into inevitable issues in hindering healthy development. The elderly, compared with the non-elderly, have unique social and biological characteristics, so psychological problem of the older population deserves special focus. Literatures have investigated aged people with depression or anxiety disorder, but somatic symptom in elderly have rarely been addressed. Somatic symptom disorder prevalence in elderly in European ranged from 0-13.5%. However, there is no research comparing the incidence of somatic symptom, anxiety and depression between elderly and non-elderly and revealing the prevalence of somatic symptom under Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.
Investigators use Somatic Symptom Scale-China (SSS-CN) questionnaire to assess the presence and severity of the symptoms. Patient Heath Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Screener (GAD-7) are used to evaluate depression and anxiety disorder respectively. The study aims to clarify the prevalence of somatic symptom, depression and anxiety disorders in China, to compare physical and psychological difference between the elderly and non-elderly and to explore risk factors for somatic symptom in the elderly.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Shanghai, China
- Renji Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200127
- Renji Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- voluntary participants and gave written consent to participates the study;
- undertook SSS-CN questionnaire, PHQ-9 and GAD questionnaires;
Exclusion Criteria:
- patients who have lost their self-assessed abilities or refuse to participate ;
- patient with cancer and central nervous system disease;
- patients who have been previously confirmed serious mental disorders, mental retardation or dementia.
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Elderly
Over 60 years old
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SSS-CN questionnaire is used to assess the presence and severity of the somatic symptoms
PHQ-9 questionnaire is used to assess the presence and severity of the depressive symptoms
GAD-7 questionnaire is used to assess the presence and severity of the anxiety disorder
|
|
Non-Elderly
Under 60 years old
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SSS-CN questionnaire is used to assess the presence and severity of the somatic symptoms
PHQ-9 questionnaire is used to assess the presence and severity of the depressive symptoms
GAD-7 questionnaire is used to assess the presence and severity of the anxiety disorder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants With Somatic Symptoms Disorder
Time Frame: Within 24 hours of the questionnaire completion.
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The scores of Somatic Symptom Scale-China (SSS-CN) questionnaire were recorded.
The score higher than 20 was taken as somatic symptom disorder.
Percentage of somatic symptom disorder in elderly and in non-elderly were analyzed.
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Within 24 hours of the questionnaire completion.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Somatic Symptoms Disorder Accompanied With Anxiety
Time Frame: Within 24 hours of the questionnaire completion.
|
anxiety disorder were assessed by Generalized Anxiety Disorder-7 (GAD-7).
The percentage of anxiety disorder among the participants with somatic symptoms disorder were analyzed.
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Within 24 hours of the questionnaire completion.
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Number of Participants With Somatic Symptoms Disorder Accompanied With Depression
Time Frame: Within 24 hours of the questionnaire completion.
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Depressive disorder were assessed by Patient Health Questionnaire-9 (PHQ-9).
The percentage of depressive disorder among the participants with somatic symptoms disorder were analyzed.
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Within 24 hours of the questionnaire completion.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Meng Jiang, MD, RenJi Hospital, School of Medicine, Shanghai Jiantong University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSSCN202011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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