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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly | Over 60 years old |
| |
| Non-Elderly | Under 60 years old |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of somatic symptom disorder with SSS-CN | Diagnostic Test | SSS-CN questionnaire is used to assess the presence and severity of the somatic symptoms |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 24 hours of the questionnaire completion. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 24 hours of the questionnaire completion. |
| Number of Participants With Somatic Symptoms Disorder Accompanied With Depression |
Inclusion Criteria:
Exclusion Criteria:
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subjects are enrolled between March 2019 and June 2019 in 105 representative community health service institutions in Shanghai, China.
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| Name | Affiliation | Role |
|---|---|---|
| Meng Jiang, MD | RenJi Hospital, School of Medicine, Shanghai Jiantong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Shanghai | Shanghai Municipality | 200127 | China | ||
| Renji Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Within 24 hours of the questionnaire completion. |
|
During the 1-day window allocated for questionnaire administration and medical history collection.
Not availale.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Meng Jiang | Renji Hospital, Shanghai Jiaotong University School of Medicine | +86 13788912766 | jiangmeng0919@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2018 | Mar 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Assessment of depressive symptoms disorder with PHQ-9 | Diagnostic Test | PHQ-9 questionnaire is used to assess the presence and severity of the depressive symptoms |
|
| Assessment of anxiety disorder with GAD-7 | Diagnostic Test | GAD-7 questionnaire is used to assess the presence and severity of the anxiety disorder |
|
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. |
| Within 24 hours of the questionnaire completion. |
| Shanghai |
| China |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Information missing | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Information missing | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Cardio/Cerebrovascular disease | Count of Participants | Participants |
|
| Other disease | Count of Participants | Participants |
|
| Surgery | Count of Participants | Participants |
|
| Antipsychotics | Count of Participants | Participants |
|
| Marital status | Information missing | Count of Participants | Participants |
|
| 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 |
|
|
| 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. | Posted | Count of Participants | Participants | Within 24 hours of the questionnaire completion. |
|
|
|
| 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. | Posted | Count of Participants | Participants | Within 24 hours of the questionnaire completion. |
|
|
|
| 0 |
| 6,814 |
| 0 |
| 6,814 |
| 0 |
| 6,814 |
| EG001 | 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 | 0 | 2,206 | 0 | 2,206 | 0 | 2,206 |
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| College |
|
| Master and above |
|
| Divorced |
|
| Widowed |
|