NCT04815863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,110

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

October 15, 2025

Completed
Last Updated

October 15, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

December 6, 2020

Results QC Date

November 14, 2022

Last Update Submit

September 25, 2025

Conditions

Somatization Disorder

Keywords

somatic symptom disorderSomatic Symptom Scale-Chinaelderly

Outcome Measures

Primary Outcomes (1)

  • 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.

Other Outcomes (2)

  • Number of Participants With Somatic Symptoms Disorder Accompanied With Anxiety

    Within 24 hours of the questionnaire completion.

  • Number of Participants With Somatic Symptoms Disorder Accompanied With Depression

    Within 24 hours of the questionnaire completion.

Study Arms (2)

Elderly

Over 60 years old

Diagnostic Test: Assessment of somatic symptom disorder with SSS-CNDiagnostic Test: Assessment of depressive symptoms disorder with PHQ-9Diagnostic Test: Assessment of anxiety disorder with GAD-7

Non-Elderly

Under 60 years old

Diagnostic Test: Assessment of somatic symptom disorder with SSS-CNDiagnostic Test: Assessment of depressive symptoms disorder with PHQ-9Diagnostic Test: Assessment of anxiety disorder with GAD-7

Interventions

Assessment of somatic symptom disorder with SSS-CNDIAGNOSTIC_TEST

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

ElderlyNon-Elderly
Assessment of depressive symptoms disorder with PHQ-9DIAGNOSTIC_TEST

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

ElderlyNon-Elderly
Assessment of anxiety disorder with GAD-7DIAGNOSTIC_TEST

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

ElderlyNon-Elderly

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

subjects are enrolled between March 2019 and June 2019 in 105 representative community health service institutions in Shanghai, China.

You may qualify if:

  • voluntary participants and gave written consent to participates the study;
  • undertook SSS-CN questionnaire, PHQ-9 and GAD questionnairesï¼›

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Renji Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Somatoform Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

Title
Dr. Meng Jiang
Organization
Renji Hospital, Shanghai Jiaotong University School of Medicine
jiangmeng0919@163.com
+86 13788912766

Study Officials

  • Meng Jiang, MD

    RenJi Hospital, School of Medicine, Shanghai Jiantong University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2020

First Posted

March 25, 2021

Study Start

March 1, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

October 15, 2025

Results First Posted

October 15, 2025

Record last verified: 2025-09

Locations

CN(2)