Assessment of SSD in Outpatients by Using SSS-CN

Somatization Disorder Clinical Trial

— EARLY-MYO-SSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03513185
• Other study ID #: SSSCN2018
• Status: Recruiting
• Start date: September 1, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2020
• Source: RenJi Hospital
• Contact: Meng Jiang, MD
• Phone: 13788912766
• Email: jiangmeng0919[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. age 18-80 years old;

2. patients who have no previous diagnosed somatic disease;

3. patients without systemic disease that can account the physical discomfort;

4. patients who agree to take the checklists and undertake assessment from a physician.

Exclusion Criteria:

1. patients who have lost their self-assessed abilities or refuse to participate in;

2. patients who have been previously confirmed serious mental disorders, mental retardation or dementia;

3. patients who are taking anti-anxiety agents or anti-depression agents;

4. patients who are unable to complete at least 1 time follow-up.

Related Conditions & MeSH terms

• Medically Unexplained Symptoms
• Somatization Disorder
• Somatoform Disorders

Intervention

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.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The assessment of treatment efficacy by SSS-CN	Investigators hypothesize that the SSS-CN is effective in monitoring treatment efficacy of SSD in primary care patients.	Two,6,10 weeks after patients with correspondent medications.
Secondary	The advantage of SSS-CN	To explore whether SSS-CN is non-inferior compared with PHQ-15.	Baseline and 2,6,10 weeks after patients with correspondent medications.
Secondary	SSD companioned with anxiety or depression	To evaluate how often does SSD companioned with anxiety or depression, or at which circumstance does SSD companioned with anxiety or depression.	Baseline and 2,6,10 weeks after patients with correspondent medications.