Trial Outcomes & Findings for Assessment of Somatic Symptom in Chinese Community-Dwelling People (NCT NCT04815863)
NCT ID: NCT04815863
Last Updated: 2025-10-15
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
9110 participants
Primary outcome timeframe
Within 24 hours of the questionnaire completion.
Results posted on
2025-10-15
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
6874
|
2236
|
|
Overall Study
COMPLETED
|
6814
|
2206
|
|
Overall Study
NOT COMPLETED
|
60
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Information missing
Baseline characteristics by cohort
| Measure |
Elderly
n=6814 Participants
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
|
Non-Elderly
n=2206 Participants
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
|
Total
n=9020 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-59
|
0 Participants
n=6814 Participants
|
2206 Participants
n=2206 Participants
|
2206 Participants
n=9020 Participants
|
|
Age, Customized
≥60
|
6814 Participants
n=6814 Participants
|
0 Participants
n=2206 Participants
|
6814 Participants
n=9020 Participants
|
|
Sex: Female, Male
Female
|
2567 Participants
n=6798 Participants • Information missing
|
693 Participants
n=2202 Participants • Information missing
|
3260 Participants
n=9000 Participants • Information missing
|
|
Sex: Female, Male
Male
|
4231 Participants
n=6798 Participants • Information missing
|
1509 Participants
n=2202 Participants • Information missing
|
5740 Participants
n=9000 Participants • Information missing
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
6814 participants
n=6814 Participants
|
2206 participants
n=2206 Participants
|
9020 participants
n=9020 Participants
|
|
Education
Middle School and below
|
3481 Participants
n=6798 Participants • Information missing
|
670 Participants
n=2202 Participants • Information missing
|
4151 Participants
n=9000 Participants • Information missing
|
|
Education
High school
|
2010 Participants
n=6798 Participants • Information missing
|
617 Participants
n=2202 Participants • Information missing
|
2627 Participants
n=9000 Participants • Information missing
|
|
Education
College
|
1262 Participants
n=6798 Participants • Information missing
|
859 Participants
n=2202 Participants • Information missing
|
2121 Participants
n=9000 Participants • Information missing
|
|
Education
Master and above
|
45 Participants
n=6798 Participants • Information missing
|
56 Participants
n=2202 Participants • Information missing
|
101 Participants
n=9000 Participants • Information missing
|
|
Hypertension
Yes
|
3621 Participants
n=6814 Participants
|
409 Participants
n=2206 Participants
|
4030 Participants
n=9020 Participants
|
|
Hypertension
No
|
3193 Participants
n=6814 Participants
|
1797 Participants
n=2206 Participants
|
4990 Participants
n=9020 Participants
|
|
Diabetes mellitus
Yes
|
1731 Participants
n=6814 Participants
|
190 Participants
n=2206 Participants
|
1921 Participants
n=9020 Participants
|
|
Diabetes mellitus
No
|
5083 Participants
n=6814 Participants
|
2016 Participants
n=2206 Participants
|
7099 Participants
n=9020 Participants
|
|
Cardio/Cerebrovascular disease
Yes
|
1910 Participants
n=6814 Participants
|
154 Participants
n=2206 Participants
|
2064 Participants
n=9020 Participants
|
|
Cardio/Cerebrovascular disease
No
|
4904 Participants
n=6814 Participants
|
2052 Participants
n=2206 Participants
|
6956 Participants
n=9020 Participants
|
|
Other disease
Yes
|
123 Participants
n=6814 Participants
|
29 Participants
n=2206 Participants
|
152 Participants
n=9020 Participants
|
|
Other disease
No
|
6691 Participants
n=6814 Participants
|
2177 Participants
n=2206 Participants
|
8868 Participants
n=9020 Participants
|
|
Surgery
Yes
|
75 Participants
n=6814 Participants
|
4 Participants
n=2206 Participants
|
79 Participants
n=9020 Participants
|
|
Surgery
No
|
6739 Participants
n=6814 Participants
|
2202 Participants
n=2206 Participants
|
8941 Participants
n=9020 Participants
|
|
Antipsychotics
Yes
|
154 Participants
n=6814 Participants
|
8 Participants
n=2206 Participants
|
162 Participants
n=9020 Participants
|
|
Antipsychotics
No
|
6660 Participants
n=6814 Participants
|
2198 Participants
n=2206 Participants
|
8858 Participants
n=9020 Participants
|
|
Marital status
Never married
|
307 Participants
n=6798 Participants • Information missing
|
172 Participants
n=2202 Participants • Information missing
|
479 Participants
n=9000 Participants • Information missing
|
|
Marital status
Married
|
5868 Participants
n=6798 Participants • Information missing
|
1842 Participants
n=2202 Participants • Information missing
|
7710 Participants
n=9000 Participants • Information missing
|
|
Marital status
Divorced
|
90 Participants
n=6798 Participants • Information missing
|
23 Participants
n=2202 Participants • Information missing
|
113 Participants
n=9000 Participants • Information missing
|
|
Marital status
Widowed
|
533 Participants
n=6798 Participants • Information missing
|
165 Participants
n=2202 Participants • Information missing
|
698 Participants
n=9000 Participants • Information missing
|
PRIMARY outcome
Timeframe: Within 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.
Outcome measures
| Measure |
Elderly
n=6814 Participants
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
|
Non-Elderly
n=2206 Participants
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
|
|---|---|---|
|
Number of Participants With Somatic Symptoms Disorder
Yes
|
4307 Participants
|
1000 Participants
|
|
Number of Participants With Somatic Symptoms Disorder
No
|
2507 Participants
|
1206 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Elderly
n=4307 Participants
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
|
Non-Elderly
n=1000 Participants
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
|
|---|---|---|
|
Number of Participants With Somatic Symptoms Disorder Accompanied With Anxiety
With anxiety disorder
|
709 Participants
|
233 Participants
|
|
Number of Participants With Somatic Symptoms Disorder Accompanied With Anxiety
Without anxiety disorder
|
3598 Participants
|
767 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 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.
Outcome measures
| Measure |
Elderly
n=4307 Participants
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
|
Non-Elderly
n=1000 Participants
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
|
|---|---|---|
|
Number of Participants With Somatic Symptoms Disorder Accompanied With Depression
With depressive disorder
|
1104 Participants
|
306 Participants
|
|
Number of Participants With Somatic Symptoms Disorder Accompanied With Depression
Without depressive disorder
|
3203 Participants
|
694 Participants
|
Adverse Events
Elderly
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Elderly
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Meng Jiang
Renji Hospital, Shanghai Jiaotong University School of Medicine
Phone: +86 13788912766
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place