Assessment of SSD in Outpatients Using SSS-CN

NCT03513185 | Completed DMC

• 1 other identifier: SSSCN2018
• Study Type: observational
• Target: 1,863
• Locations: 1 country
• Sites: 1

Brief Summary

About 70-80% of patients with somatic symptom disorder (SSD) visit the general medical hospital instead of psychiatric or other mental health settings. The current self-reporting questionnaires are neither sufficiently considering companioned anxiety or depression nor validated for monitor the treatment efficacy of such group. The Somatic Symptom Scale-China (SSS-CN) is developed due to the urging clinical demanding in general hospital. The study aims to investigate whether the SSS-CN could serve as a timely and practical instrument to detect SSD and assess the severity of the disorder.

Conditions

Somatization Disorder

Keywords

somatic symptom disorder; the Somatic Symptom Scale-China; mental disorders management

Outcome Measures

Primary Outcomes (1)

• The diagnosis accuracy of somatic burden assessment by SSS-CN

  The primary objectives of this study are to test the diagnosis accuracy of somatic burden assessment by SSS-CN. Investigators expect that somatic symptom disorder assessed by SSS-CN is as accurate as diagnoses made by the DSM-5 criterion standard

  Within 24 hours after collecting the scale.

Secondary Outcomes (3)

• The assessment of treatment efficacy by SSS-CN

  Two,6,10 weeks after patients with correspondent medications.

• The advantage of SSS-CN

  Baseline and 2,6,10 weeks after patients with correspondent medications.

• SSD companioned with anxiety or depression

  Baseline and 2,6,10 weeks after patients with correspondent medications.

Study Arms (2)

Patients with SSD

Patients are diagnosed with SSD by physician according to DSM-5,and will be treated with Deanxit, SSRI or SRNI on the basis of severity assessment by physician.

Drug: Deanxit, SSRI or SRNI

Patients with non-SSD

No SSD is diagnosed by physician according to DSM-5

Interventions

Deanxit, SSRI or SRNI DRUG

After recruiting participants and collecting the baseline data, the SSS-CN, PHQ-15, PHQ-9 and GAD-7 questionnaires will be carried out. An independent diagnosis will be made by primary care physician using the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criterion standard. Deanxit, selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI) will be selectively prescribed according to the severity category assessed by physician. Two, 6,10 weeks after patients with correspondent medications, a face-to-face interview, telephone interview or mobile-apps survey will be underwent to follow-up using the SSS-CN, PHQ-15, PHQ-9 and GAD-7 checklists.

Patients with SSD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive subjects are enrolled between September 2017 and June 2020 in the internal medicine department of Renji hospital in Shanghai, China.

You may qualify if:

• age 18-80 years old;
• patients who have no previous diagnosed somatic disease;
• patients without systemic disease that can account the physical discomfort;
• patients who agree to take the checklists and undertake assessment from a physician.

You may not qualify if:

• patients who have lost their self-assessed abilities or refuse to participate in;
• patients who have been previously confirmed serious mental disorders, mental retardation or dementia;
• patients who are taking anti-anxiety agents or anti-depression agents;
• patients who are unable to complete at least 1 time follow-up.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

• Jiang M, Zhang W, Su X, Gao C, Chen B, Feng Z, Mao J, Pu J. Identifying and measuring the severity of somatic symptom disorder using the Self-reported Somatic Symptom Scale-China (SSS-CN): a research protocol for a diagnostic study. BMJ Open. 2019 Sep 26;9(9):e024290. doi: 10.1136/bmjopen-2018-024290.

  PMID: 31558447 DERIVED

MeSH Terms

Conditions

Somatoform Disorders

Interventions

flupentixol, melitracen drug combination; Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Study Officials

• Meng Jiang, MD

  RenJi Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: May 1, 2018
• Study Start: September 1, 2017
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)