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NCT Number: NCT03513185

Assessment of SSD in Outpatients Using SSS-CN

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.

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Key information

Conditions

Somatization Disorder Mental Disorders Somatoform Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Deanxit, SSRI or SRNI

Drug

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.

Primary outcomes

  1. The diagnosis accuracy of somatic burden assessment by SSS-CN

    Time frame: 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 outcomes

  1. The assessment of treatment efficacy by SSS-CN

    Time frame: 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.

  2. The advantage of SSS-CN

    Time frame: Baseline and 2,6,10 weeks after patients with correspondent medications.

    To explore whether SSS-CN is non-inferior compared with PHQ-15.

  3. SSD companioned with anxiety or depression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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)

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 1, 2018
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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