Assessment of Somatic Symptom in Chinese Community-Dwelling People

Somatization Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04815863
• Other study ID #: SSSCN202011
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2021
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9185
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Medically Unexplained Symptoms
• Somatization Disorder
• Somatoform Disorders

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai
China	Renji Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The percentage of 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.
Other	The percentage of 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.	Within 24 hours of the questionnaire completion.
Primary	Prevalence of somatic symptoms disorder in elderly and non-elderly	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.