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Assessment of SSD in Outpatients Using SSS-CN

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Completed

Conditions

Somatization Disorder

Treatments

Drug: Deanxit, SSRI or SRNI

Study type

Observational

Funder types

Other

Identifiers

NCT03513185
SSSCN2018

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,863 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

1,863 participants in 2 patient groups

Patients with SSD
Description:
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.
Treatment:
Drug: Deanxit, SSRI or SRNI
Patients with non-SSD
Description:
No SSD is diagnosed by physician according to DSM-5

Trial contacts and locations

1

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Central trial contact

Meng Jiang, MD; Jialiang Mao, MD

Data sourced from clinicaltrials.gov

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