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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,863
- 试验地点
- 1
- 主要终点
- The diagnosis accuracy of somatic burden assessment by SSS-CN
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80 years old;
- •patients who have no previous diagnosed somatic disease;
- •patients without systemic disease that can account the physical discomfort;
- •patients who agree to take the checklists and undertake assessment from a physician.
排除标准
- •patients who have lost their self-assessed abilities or refuse to participate in;
- •patients who have been previously confirmed serious mental disorders, mental retardation or dementia;
- •patients who are taking anti-anxiety agents or anti-depression agents;
- •patients who are unable to complete at least 1 time follow-up.
研究组 & 干预措施
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.
干预措施: Deanxit, SSRI or SRNI (Drug)
结局指标
主要结局
The diagnosis accuracy of somatic burden assessment by SSS-CN
时间窗: 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
次要结局
- SSD companioned with anxiety or depression(Baseline and 2,6,10 weeks after patients with correspondent medications.)
- The assessment of treatment efficacy by SSS-CN(Two,6,10 weeks after patients with correspondent medications.)
- The advantage of SSS-CN(Baseline and 2,6,10 weeks after patients with correspondent medications.)