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Assessment of Somatic Symptom in Chinese Community-Dwelling People

A Comparison of Somatic Symptom Among Elderly and Non-elderly in Chinese Community-Dwelling People

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04815863
Enrollment
9110
Registered
2021-03-25
Start date
2019-03-01
Completion date
2019-06-30
Last updated
2025-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Somatization Disorder

Keywords

somatic symptom disorder, Somatic Symptom Scale-China, elderly

Brief summary

With the rapid aging and worsening psychological problems worldwide, the special focus on somatic symptom and other psychological diseases of the older population is needed. However, there is no research comparing the incidence of somatic symptom between elderly and non-elderly, and clinical relevance with somatic symptom is uncertain. 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.

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.

Interventions

DIAGNOSTIC_TESTAssessment of somatic symptom disorder with SSS-CN

SSS-CN questionnaire is used to assess the presence and severity of the somatic symptoms

DIAGNOSTIC_TESTAssessment of depressive symptoms disorder with PHQ-9

PHQ-9 questionnaire is used to assess the presence and severity of the depressive symptoms

DIAGNOSTIC_TESTAssessment of anxiety disorder with GAD-7

GAD-7 questionnaire is used to assess the presence and severity of the anxiety disorder

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1. voluntary participants and gave written consent to participates the study; 2. undertook SSS-CN questionnaire, PHQ-9 and GAD questionnaires;

Exclusion criteria

1. patients who have lost their self-assessed abilities or refuse to participate ; 2. patient with cancer and central nervous system disease; 3. patients who have been previously confirmed serious mental disorders, mental retardation or dementia.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Somatic Symptoms DisorderWithin 24 hours of the questionnaire completion.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.

Other

MeasureTime frameDescription
Number of Participants With Somatic Symptoms Disorder Accompanied With AnxietyWithin 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.
Number of Participants With Somatic Symptoms Disorder Accompanied With DepressionWithin 24 hours of the questionnaire completion.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.

Countries

China

Participant flow

Participants by arm

ArmCount
Elderly
Over 60 years old Assessment of somatic symptom disorder with SSS-CN: SSS-CN questionnaire is used to assess the presence and severity of the somatic symptoms Assessment of depressive symptoms disorder with PHQ-9: PHQ-9 questionnaire is used to assess the presence and severity of the depressive symptoms Assessment of anxiety disorder with GAD-7: GAD-7 questionnaire is used to assess the presence and severity of the anxiety disorder
6,814
Non-Elderly
Under 60 years old Assessment of somatic symptom disorder with SSS-CN: SSS-CN questionnaire is used to assess the presence and severity of the somatic symptoms Assessment of depressive symptoms disorder with PHQ-9: PHQ-9 questionnaire is used to assess the presence and severity of the depressive symptoms Assessment of anxiety disorder with GAD-7: GAD-7 questionnaire is used to assess the presence and severity of the anxiety disorder
2,206
Total9,020

Baseline characteristics

CharacteristicNon-ElderlyTotalElderly
Age, Customized
18-59
2206 Participants2206 Participants0 Participants
Age, Customized
≥60
0 Participants6814 Participants6814 Participants
Antipsychotics
No
2198 Participants8858 Participants6660 Participants
Antipsychotics
Yes
8 Participants162 Participants154 Participants
Cardio/Cerebrovascular disease
No
2052 Participants6956 Participants4904 Participants
Cardio/Cerebrovascular disease
Yes
154 Participants2064 Participants1910 Participants
Diabetes mellitus
No
2016 Participants7099 Participants5083 Participants
Diabetes mellitus
Yes
190 Participants1921 Participants1731 Participants
Education
College
859 Participants2121 Participants1262 Participants
Education
High school
617 Participants2627 Participants2010 Participants
Education
Master and above
56 Participants101 Participants45 Participants
Education
Middle School and below
670 Participants4151 Participants3481 Participants
Hypertension
No
1797 Participants4990 Participants3193 Participants
Hypertension
Yes
409 Participants4030 Participants3621 Participants
Marital status
Divorced
23 Participants113 Participants90 Participants
Marital status
Married
1842 Participants7710 Participants5868 Participants
Marital status
Never married
172 Participants479 Participants307 Participants
Marital status
Widowed
165 Participants698 Participants533 Participants
Other disease
No
2177 Participants8868 Participants6691 Participants
Other disease
Yes
29 Participants152 Participants123 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
China
2206 participants9020 participants6814 participants
Sex: Female, Male
Female
693 Participants3260 Participants2567 Participants
Sex: Female, Male
Male
1509 Participants5740 Participants4231 Participants
Surgery
No
2202 Participants8941 Participants6739 Participants
Surgery
Yes
4 Participants79 Participants75 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 6,8140 / 2,206
other
Total, other adverse events
0 / 6,8140 / 2,206
serious
Total, serious adverse events
0 / 6,8140 / 2,206

Outcome results

Primary

Number of Participants With Somatic Symptoms Disorder

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.

Time frame: Within 24 hours of the questionnaire completion.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ElderlyNumber of Participants With Somatic Symptoms DisorderYes4307 Participants
ElderlyNumber of Participants With Somatic Symptoms DisorderNo2507 Participants
Non-ElderlyNumber of Participants With Somatic Symptoms DisorderYes1000 Participants
Non-ElderlyNumber of Participants With Somatic Symptoms DisorderNo1206 Participants
Other Pre-specified

Number of Participants With Somatic Symptoms Disorder Accompanied With Anxiety

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.

Time frame: Within 24 hours of the questionnaire completion.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
ElderlyNumber of Participants With Somatic Symptoms Disorder Accompanied With AnxietyWith anxiety disorder709 Participants
ElderlyNumber of Participants With Somatic Symptoms Disorder Accompanied With AnxietyWithout anxiety disorder3598 Participants
Non-ElderlyNumber of Participants With Somatic Symptoms Disorder Accompanied With AnxietyWith anxiety disorder233 Participants
Non-ElderlyNumber of Participants With Somatic Symptoms Disorder Accompanied With AnxietyWithout anxiety disorder767 Participants
Other Pre-specified

Number of Participants With Somatic Symptoms Disorder Accompanied With Depression

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.

Time frame: Within 24 hours of the questionnaire completion.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ElderlyNumber of Participants With Somatic Symptoms Disorder Accompanied With DepressionWith depressive disorder1104 Participants
ElderlyNumber of Participants With Somatic Symptoms Disorder Accompanied With DepressionWithout depressive disorder3203 Participants
Non-ElderlyNumber of Participants With Somatic Symptoms Disorder Accompanied With DepressionWith depressive disorder306 Participants
Non-ElderlyNumber of Participants With Somatic Symptoms Disorder Accompanied With DepressionWithout depressive disorder694 Participants

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026