Clinical trial NCT03513185: Assessment of SSD in Outpatients by Using SSS-CN
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Somatization Disorder
Keywords: somatic symptom disorder
the Somatic Symptom Scale-China
mental disorders management
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The diagnosis accuracy of somatic burden assessment by SSS-CN
timeFrame: Within 24 hours after collecting the scale.
Secondary outcomes:
measure: The assessment of treatment efficacy by SSS-CN
timeFrame: Two,6,10 weeks after patients with correspondent medications.
measure: The advantage of SSS-CN
timeFrame: Baseline and 2,6,10 weeks after patients with correspondent medications.
measure: SSD companioned with anxiety or depression
timeFrame: Baseline and 2,6,10 weeks after patients with correspondent medications.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Meng Jiang, MD
role: STUDY_CHAIR
References:
citation: 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.