Assessment of SSD in Outpatients by Using SSS-CN

• Conditions: Somatization Disorder
• Interventions: Drug: Deanxit, SSRI or SRNI

• Registration Number: NCT03513185
• Lead Sponsor: RenJi Hospital

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.

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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-04-28
• Study First Posted: 2018-05-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08
• Primary Completion: 2021-05-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with SSD	Deanxit, SSRI or SRNI	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.

Primary Outcome Measures

Name	Time	Method
The diagnosis accuracy of somatic burden assessment by SSS-CN	Within 24 hours after collecting the scale.	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China