NCT03513185

Assessment of SSD in Outpatients Using SSS-CN

The EARLY Validation and Utility of Somatic Symptom Scale CHINA for Assessing Somatic Symptom Disorder in MYOcardial Outpatients of General Hospital (EARLY-MYO-SSS-CN)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,863 (actual)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

One of the most common medical conditions seen in general hospital is somatic symptoms disorder (SSD). As the disorder is characterized by the prominent attention to somatic concerns, patients mainly present initially in medical rather than mental health care settings. The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) is currently the "gold standard" for the diagnosis of SSD, but it is clinically hard to follow. Thus, It is more clinically practical to detect a disorder by self-administered questionnaires, that patients can score symptoms according to their own condition and severity in a short time. However, the current self-reporting questionnaires, such as the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder Scale-7 (GAD-7), and the Patient Health Questionnaire-15 (PHQ-15) are neither sufficiently considering companioned anxiety or depression nor validated for monitor the treatment efficacy of SSD patients. The Somatic Symptom Scale-China (SSS-CN) is developed based on DSM-5 to assess SSD, and it is an abbreviated 20-item version of somatic symptoms that can be entirely self-administered by the patient, but its assessment value has not yet been widely tested. 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

Interventions

Type	Name	Description
DRUG	Deanxit, SSRI or SRNI	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.

Timeline

• Start date: 2017-09-01
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2018-05-01
• Last updated: 2025-10-01

Locations

1 site across 1 country: China