Clinical trial NCT04815863: Assessment of Somatic Symptom in Chinese Community-Dwelling People
Official title: A Comparison of Somatic Symptom Among Elderly and Non-elderly in Chinese Community-Dwelling People
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Somatization Disorder
Keywords: somatic symptom disorder
Somatic Symptom Scale-China
elderly
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 9185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: subjects are enrolled between March 2019 and June 2019 in 105 representative community health service institutions in Shanghai, China.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of somatic symptoms disorder in elderly and non-elderly
timeFrame: Within 24 hours of the questionnaire completion.
Secondary outcomes:
Other outcomes:
measure: The percentage of somatic symptoms disorder accompanied with anxiety
timeFrame: Within 24 hours of the questionnaire completion.
measure: The percentage of somatic symptoms disorder accompanied with depression
timeFrame: Within 24 hours of the questionnaire completion.
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
affiliation: RenJi Hospital, School of Medicine, Shanghai Jiantong University
name: Meng Jiang, MD
role: STUDY_CHAIR
References: