Somatization DisorderNCT03513185
Assessment of SSD in Outpatients Using SSS-CN
An observational study of Somatization Disorder, run by RenJi Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Somatization Disorder
- What is being tested?
- Deanxit, SSRI or SRNI
- How many people
- 1,863 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive subjects are enrolled between September 2017 and June 2020 in the internal medicine department of Renji hospital in Shanghai, China.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
Read the 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.
- Conditions
- Somatization Disorder
- Being tested
- Deanxit, SSRI or SRNI
- Keywords
- somatic symptom disorder, the Somatic Symptom Scale-China, mental disorders management
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deanxit, SSRI or SRNIDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Deanxit, SSRI or SRNI | |
| Patients with non-SSD | No SSD is diagnosed by physician according to DSM-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 24 hours after collecting the scale.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 2,6,10 weeks after patients with correspondent medications.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start1 Sep 2017
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Somatization DisorderStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,863 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng Jiang, MD, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513185
- Sponsor's protocol ID
- SSSCN2018
- Status last verified
- Sep 2025
- First submitted
- 1 Feb 2018
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31558447
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT03513185
- Acronym / sponsor ID
- SSSCN2018
- Conditions
- Somatization Disorder
- Keywords
- somatic symptom disorder, the Somatic Symptom Scale-China, mental disorders management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,863 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with SSD | – | Drug: Deanxit, SSRI or SRNIPatients 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. |
| Patients with non-SSD | – | –No SSD is diagnosed by physician according to DSM-5 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive subjects are enrolled between September 2017 and June 2020 in the internal medicine department of Renji hospital in Shanghai, China.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deanxit, SSRI or SRNIAfter 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. | Drug | Patients with SSD |
Primary outcome
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
3 secondary outcomes
The assessment of treatment efficacy by SSS-CN
Time frame: Two,6,10 weeks after patients with correspondent medications.
The advantage of SSS-CN
Time frame: Baseline and 2,6,10 weeks after patients with correspondent medications.
SSD companioned with anxiety or depression
Time frame: Baseline and 2,6,10 weeks after patients with correspondent medications.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 31558447Jiang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng Jiang, MD study chair
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Somatization Disorder, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnosis accuracy of somatic burden assessment by SSS-CN (time frame: Within 24 hours after collecting the scale.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03513185, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.