Assessment of SSD in Outpatients by Using SSS-CN (EARLY-MYO-SSS)

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

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.

Study Overview

• Status: Unknown
• Conditions: Somatization Disorder
• Intervention / Treatment: Drug: Deanxit, SSRI or SRNI

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 Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: Jialiang Mao, MD; Phone Number: 68383477 13311606283; Email: maoji@aliyun.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • RenJi Hospital
      • Contact: Xuan Su, postgraduate; Phone Number: 68385925 18817560226; Email: 18817560226@163.com
      • Contact: Bingxu Chen, postgraduate; Phone Number: 15800539513; Email: zhyp0818@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 non-SSD; No SSD is diagnosed by physician according to DSM-5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Chair: Meng Jiang, MD, RenJi Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): May 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: April 28, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: somatic symptom disorder; the Somatic Symptom Scale-China; mental disorders management
• Additional Relevant MeSH Terms: Mental Disorders; Somatoform Disorders; Medically Unexplained Symptoms
• Other Study ID Numbers: SSSCN2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No