Somatization DisorderNCT04815863
Assessment of Somatic Symptom in Chinese Community-Dwelling People
An observational study of Somatization Disorder, run by RenJi Hospital at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Somatization Disorder
- What is being tested?
- Assessment of somatic symptom disorder with SSS-CN, Assessment of depressive symptoms disorder with PHQ-9 and Assessment of anxiety disorder with GAD-7
- How many people
- 9,110 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2019to 30 Jun 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects are enrolled between March 2019 and June 2019 in 105 representative community health service institutions in Shanghai, China.
Who may be able to join
- voluntary participants and gave written consent to participates the study;
- undertook SSS-CN questionnaire, PHQ-9 and GAD questionnaires；
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Renji Hospital
Shanghai
About this study
Official title: A Comparison of Somatic Symptom Among Elderly and Non-elderly in Chinese Community-Dwelling People
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.
Read the 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.
- Conditions
- Somatization Disorder
- Being tested
- Assessment of somatic symptom disorder with SSS-CN, Assessment of depressive symptoms disorder with PHQ-9, Assessment of anxiety disorder with GAD-7
- Keywords
- somatic symptom disorder, Somatic Symptom Scale-China, elderly
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of somatic symptom disorder with SSS-CNDiagnostic test
SSS-CN questionnaire is used to assess the presence and severity of the somatic symptoms
Assessment of depressive symptoms disorder with PHQ-9Diagnostic test
PHQ-9 questionnaire is used to assess the presence and severity of the depressive symptoms
Assessment of anxiety disorder with GAD-7Diagnostic test
GAD-7 questionnaire is used to assess the presence and severity of the anxiety disorder
| Study group | Role | What they receive |
|---|---|---|
| Elderly | Over 60 years old Receives: Diagnostic Test: Assessment of somatic symptom disorder with SSS-CN; Diagnostic Test: Assessment of depressive symptoms disorder with PHQ-9; Diagnostic Test: Assessment of anxiety disorder with GAD-7 | |
| Non-Elderly | Under 60 years old Receives: Diagnostic Test: Assessment of somatic symptom disorder with SSS-CN; Diagnostic Test: Assessment of depressive symptoms disorder with PHQ-9; Diagnostic Test: Assessment of anxiety disorder with GAD-7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours of the questionnaire completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Mar 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Somatization DisorderStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 9,110 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng Jiang, MD, Study chair, RenJi Hospital, School of Medicine, Shanghai Jiantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815863
- Sponsor's protocol ID
- SSSCN202011
- Status last verified
- Sep 2025
- First submitted
- 6 Dec 2020
- Last updated
- 15 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Somatic Symptom Among Elderly and Non-elderly in Chinese Community-Dwelling People
- ClinicalTrials.gov ID
- NCT04815863
- Acronym / sponsor ID
- SSSCN202011
- Conditions
- Somatization Disorder
- Keywords
- somatic symptom disorder, Somatic Symptom Scale-China, elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,110 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Posted 15 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly | – | Diagnostic Test: Assessment of somatic symptom disorder with SSS-CN, Diagnostic Test: Assessment of depressive symptoms disorder with PHQ-9, Diagnostic Test: Assessment of anxiety disorder with GAD-7Over 60 years old |
| Non-Elderly | – | Diagnostic Test: Assessment of somatic symptom disorder with SSS-CN, Diagnostic Test: Assessment of depressive symptoms disorder with PHQ-9, Diagnostic Test: Assessment of anxiety disorder with GAD-7Under 60 years old |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects are enrolled between March 2019 and June 2019 in 105 representative community health service institutions in Shanghai, China.
Key inclusion criteria (2 listed)
- voluntary participants and gave written consent to participates the study;
- undertook SSS-CN questionnaire, PHQ-9 and GAD questionnaires；
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of somatic symptom disorder with SSS-CNSSS-CN questionnaire is used to assess the presence and severity of the somatic symptoms | Diagnostic test | Elderly, Non-Elderly |
| Assessment of depressive symptoms disorder with PHQ-9PHQ-9 questionnaire is used to assess the presence and severity of the depressive symptoms | Diagnostic test | Elderly, Non-Elderly |
| Assessment of anxiety disorder with GAD-7GAD-7 questionnaire is used to assess the presence and severity of the anxiety disorder | Diagnostic test | Elderly, Non-Elderly |
Primary outcome
Number of Participants With Somatic Symptoms Disorder
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng Jiang, MD study chair
RenJi Hospital, School of Medicine, Shanghai Jiantong University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Somatization Disorder, run by RenJi Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Somatic Symptoms Disorder (time frame: Within 24 hours of the questionnaire completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.