A Comparison of Somatic Symptom Among Elderly and Non-elderly in Chinese Community-Dwelling People
Conditions: Somatization Disorder
Sponsor: RenJi Hospital

 
 
Prevalence and characteristics of somatic symptom disorder in the elderly in a community-
based population: a large-scale cross-sectional study in China 
Assessment of Somatic Symptom in Chinese Community-Dwelling People 
 
Protocol Number 
SSSCN202011 
NCT No. 
NCT04815863 
Date 
Sep 20, 2018 
 
 
 

STUDY PROTOCOL SYNOPSIS 
Title  
Prevalence and characteristics of somatic symptom disorder in the 
elderly in a community-based population: a large-scale cross-
sectional study in China 
Sponsor 
Investigator-Initiated Trial (IIT) 
Primary Objectives  1. to clarify the prevalence of somatic symptom disorder (SSD), 
depressive disorders, and anxiety disorders in the elderly in China; 
2. to identify physical and psychological differences between the 
elderly and non-elderly; 
3. to explore risk factors for SSD in the elderly. 
Study Design 
This prospective cross-sectional study (Assessment of Somatic 
Symptom in Chinese Community-Dwelling People, 
ClinicalTrials.gov identifier NCT04815863, registered on 
06/12/2020) is a multicenter registry conducted in Shanghai, China, 
under the supervision of the Shanghai Association of Chinese 
Integrative Medicine. 
A multistage and stratified systematic sampling technique will be 
used to choose representative districts from sixteen districts in 
Shanghai, which are then divided into low, medium, and high 
economic levels according to the per capita gross domestic product 
of each district in 2018. Eleven districts will be selected 
proportionally and randomly and represented by 105 community 
health service institutions. The study was approved by institutional 
review committees at each center. The study is compliant with the 
1975 Declaration of Helsinki guidelines. 
(1) assessment of somatic symptom disorder (SSD) 
The Somatic Symptom questionnaire is self-administered with an 
abbreviated 20-item measure. Briefly, it is composed of four 
dimensions: physical disorders, depressive disorders, anxiety 
disorders and depressive and anxiety disorders. Half of the items ask 
about physical complaints (one item per body system). SSS-CN 
scores ranging from 20 to 29, 30–39, 40–59 and ≥ 60 correspond to 
normal, mild, moderate and severe SSD, respectively. 
(2) assessment of depressive and anxiety disorders 
All participants will be assessed for depressive and anxiety 
disorders according to the PHQ-9 and GAD-7, which evaluate the 
frequencies at which certain symptoms had been experienced over 
the last two weeks, ranging from 0 (‘not at all’) to 3 (‘nearly every 
day’). The cutoff values are listed below. For PHQ-9, scores of 5–9 
indicate mild depressive disorder, 10–14 indicate moderate 
depressive disorder, 15–19 indicate moderately severe depressive 
disorder and≥20 indicate severe depressive disorder. For GAD-7, 
scores range from 0 to 21, with scores of 5–9, 10–14, and ≥ 15 

representing mild, moderate, and severe anxiety symptom levels, 
respectively. 
(3) sociodemographic and clinical characteristics 
Sociodemographic data, including age, gender, level of education 
and marital status, will also be collected. A semi-structured 
questionnaire concerning clinical characteristics will be administered 
to survey participants’ medical and medication histories. 
Number of 
Subjects 
Enrollment: 9110 [anticipate] 
Elderly group: 6874 [anticipate] 
Non-elderly group: 2236 [anticipate] 
Enrollment 
Criteria 
Inclusion criteria were: 
(1) voluntary participation and provision of written consent to 
participate in the study’s evaluation and assessment; 
(2) completion of the SSS-CN questionnaire, Patient Health 
Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 
(GAD- 7) questionnaires. 
Exclusion criteria were : 
(1) patients lacking self-assessed abilities or who refused to 
participate; 
(2) patients who have been previously confirmed to have serious 
mental disorders, mental retardation, or dementia; 
(3) patients with cancer or central nervous system diseases; 
(4) patients with any missing data within questionnaire items or with 
more than one item missing from sociodemographic information; 
(5) patients with any medical conditions that in the opinion of the 
investigators will not be appropriate to participate in the study. 
Safety Assessment 
Adverse events were not required in this study protocol. 
Endpoints 
1. Number of Participants With Somatic Symptoms Disorder 
2. Number of Participants With Somatic Symptoms Disorder 
Accompanied With Anxiety 
3. Number of Participants With Somatic Symptoms Disorder 
Accompanied With Depression 
Statistical 
Analysis 
Descriptive statistics for each group, such as counts and percentages 
(%) for non-continuous variables, will be reported for all 
sociodemographic and clinical characteristics. The prevalences of 
SSD of various severities for different genders and for participants 
diagnosed with depressive and anxiety disorders will be calculated. 
In order to assess whether SSD, depressive and anxiety disorders are 
associated with aged groups and whether depressive and anxiety 
disorders are associated with the severity of SSD, binary logistic 
regressions will be performed, adjusting for gender, educational 
level (middle school and below, high school, college, master and 
above), marital status (never married, married, divorced, widowed), 
hypertension (yes/no), diabetes mellitus (yes/ no), CV disease 

(yes/no), endocrine and metabolic disease except DM (yes/no), other 
diseases (yes/no), surgery (yes/no) and antipsychotic intake (yes/no) 
in all models. 
Univariate analyses and binary logistic regression models will be 
used to assess the effects of sociodemographic factors and clinical 
characteristics on SSD in the non- elderly and elderly. Categorical 
sociodemographic and clinical variables will be analyzed by chi-
square test. Binary logistic regressions will be performed using SSD 
(yes/no) as the dependent variable, adjusting for gender, educational 
level, marital status, and antipsychotic intake. 
Fisher’s exact test was used instead of the chi-square test only when 
one or more expectations for each cell of the 2-by-2 tables was 
below 5. A significance level was set at a p-value < 0.05 (two-tailed). 
Missing data were imputed with a multiple imputation approach. All 
statistical analyses were performed with SPSS 22 (IBM SPSS 
Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp).