DepressionNCT04500379
Reliability and Validity of FIBSER, STAR-P, HEA Scale The Reliability and Validity of Chinese Version of FIBSER, STAR-P, HEA Scale in Depression Assessment
An observational study of Depression, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
According to the survey of the World Health Organization, the number of patients with depression in the world has reached 350 million, has becoming the primary cause of disability and the main disease burden worldwide. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2020to 28 Dec 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Depressive disorder group: The samples were from the outpatients and inpatients of Shanghai Mental Health Center and Shanghai Pudong New Area Mental Health Center from January 2020 to December 2020, and met DSM-5 diagnostic criteria. Sixty patients aged 1865 were enrolled in the group. Healthy control group: The sample comes from the healthy people recruited by the society who meet the entry criteria of the control group and match the gender, age and education level, and 60 cases are planned to be enrolled in the group.
Who may be able to join
- Case group:
- The subjects were psychiatric outpatients and inpatients who were able and willing to provide informed consent.
- Men or women aged between 18 and 65, with junior high school education or above.
- according to DSM-5 criteria, patients diagnosed with depressive disorder.
- The total score of Hamilton Depression Scale (HAM-D) was ≥7 and the total score of Young Mania Scale (YMRS) was ≤5.
- subjects were treated with antidepressants at least two weeks before the study visit, all of them were SSRIs.
- Control group:
- 1）did not meet the diagnostic criteria of any axis I in DSM-5. 2）18-65 years old, with junior high school education or above. 3）Willing to participate in this study, and the subjects signed the informed consent form.
Who cannot join
- 1）severe drug allergy. 2）Suffering from some serious physical diseases adversely affects the validity of neuropsychological test data.
- 3）serious negative suicide concept.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center IRB
Shanghai, 200030
Jun Chen, M.D., Ph.D, 021-34773367, doctorcj2010@gmail.com
About this study
Official title: The Reliability and Validity of Chinese Version of FIBSER, STAR-P, HEA Scale in Depression
According to the survey of the World Health Organization, the number of patients with depression in the world has reached 350 million, has becoming the primary cause of disability and the main disease burden worldwide. In order to better dealing with adverse reactions, improving the doctor-patient relationship and optimizing the treatment cost, FIBSER, STAR-P and HEA Health Economics Follow-up Evaluation Scale are selected as simple and quick evaluation scales to evaluate the influence, doctor-patient relationship and social and economic benefits after drug treatment in clinical treatment. At present, the reliability and validity of FIBSER, STAR-P and HEA scales will be verified the reliability and validity of the above three scales in depressive disorder, aiming at enriching the treatment of depressive patients based on assessment, thus improving the compliance of medication for depressive disorder, improving the doctor-patient relationship and reducing the total burden of social diseases.
Read the detailed description
In this study, the reliability and validity of FIBSER Scale, Doctor-patient Relationship Scale-Patient Edition (STAR-P) and HEA in Chinese population will be verified to increase the diversity and selectivity of domestic assessment tools.
This study includes two steps.
- baseline: demographic data, HAM-D, HAM-A, YMRS, drug side effects scale：FIBSER, TESS； doctor-patient relationship scale ：STAR-P, PDRQ-15；Health economics follow-up evaluation scale ：SDS and HEA were evaluated.
- follow-up (4 weeks): HAM-D, HAM-A, YMRS, FIBSER, STAR-P and HEA scale in order to verify the reliability of retest.
- Conditions
- Depression
- Keywords
- FIBSER, STAR-P, HEA scale
- Medical subject headings
- Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Symptom Scale TESS
Common adverse drug reactions and signs were evaluated. The "severity" column was used to evaluate the severity level of symptoms from 0 to 4. The higher the severity level, the more serious the symptoms
Measured: Up to 1 week
The Frequency, Intensity, and Burden of Side Effects Rating, FIBSER
Evaluate three areas of drug side effects through patient self-report and rank the drug impact: frequency (how many adverse reactions caused by depression drugs in the past week), intensity (how serious adverse reactions caused by depression drugs in the past week), and burden (how much adverse reactions caused by depression drugs affect your daily activities in the past week).
Measured: Up to 4 week
HEA Health Economics Follow-up Evaluation Form，HEA
The main evaluation in the past month includes the following items: how many times have you seen a doctor (doctor), other medical personnel, whether you have been in hospital, and the number of days off due to depression and other diseases
Measured: Up to 4 week
Sheehan Disability Scale ，SDS
Including three items, ask patients about the degree of damage caused by their current diseases/symptoms to their work, social interaction and family functions in turn; Visual simulation score of 0-10
Measured: Up to 1 week
Doctor-patient Relationship Scale-Patient Edition ，STAR-P Doctor-patient Relationship Scale-Patient Edition (STAR-P)
The total score of STAR-P and the scores of three subscales are adopted: active collaboration (PCO: harmonious and shared understanding of goals and mutual open and trusted experiences), active clinician input (PCI: clinicians encourage, consider, support, listen and understand patients) and non-clinician input (NCI: patients can't understand clinicians), which is composed of 12 items
Measured: Up to 4 week
PDRQ-15 Scale
There are 15 items in total, which are divided into three dimensions: patient/family satisfaction (6 items), accessibility of medical staff (7 items) and disease attitude of patients/family members.
Measured: Up to 1 week
Secondary outcomes (3)
HAM-D
To evaluate the severity of depressive symptoms by clinicians. Remission: total score < 7.
Measured: Up to 4 week
HAM-A
To evaluate the severity of anxiety symptoms by clinicians. The total score < 6: no anxiety sympotom.
Measured: Up to 4 week
YMRS
Assess symptoms of mania,the total score < 6: no mania sympotom.
Measured: Up to 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start24 Jul 2020
- Primary completion5 Oct 2021
- Study completion28 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Chen, M.D., Ph.D, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500379
- Sponsor's protocol ID
- 2020-52
- Status last verified
- Sep 2021
- First submitted
- 2 Aug 2020
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of Chinese Version of FIBSER, STAR-P, HEA Scale in Depression
- ClinicalTrials.gov ID
- NCT04500379
- Acronym / sponsor ID
- 2020-52
- Conditions
- Depression
- Keywords
- FIBSER, STAR-P, HEA scale
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 28 Dec 2022 (estimated)
- First posted
- 5 Aug 2020 (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.
According to the survey of the World Health Organization, the number of patients with depression in the world has reached 350 million, has becoming the primary cause of disability and the main disease burden worldwide. In order to better dealing with adverse reactions, improving the doctor-patient relationship and optimizing the treatment cost, FIBSER, STAR-P and HEA Health Economics Follow-up Evaluation Scale are selected as simple and quick evaluation scales to evaluate the influence, doctor-patient relationship and social and economic benefits after drug treatment in clinical treatment. At present, the reliability and validity of FIBSER, STAR-P and HEA scales will be verified the reliability and validity of the above three scales in depressive disorder, aiming at enriching the treatment of depressive patients based on assessment, thus improving the compliance of medication for depressive disorder, improving the doctor-patient relationship and reducing the total burden of social diseases.
Detailed description
In this study, the reliability and validity of FIBSER Scale, Doctor-patient Relationship Scale-Patient Edition (STAR-P) and HEA in Chinese population will be verified to increase the diversity and selectivity of domestic assessment tools.
This study includes two steps.
- baseline: demographic data, HAM-D, HAM-A, YMRS, drug side effects scale：FIBSER, TESS； doctor-patient relationship scale ：STAR-P, PDRQ-15；Health economics follow-up evaluation scale ：SDS and HEA were evaluated.
- follow-up (4 weeks): HAM-D, HAM-A, YMRS, FIBSER, STAR-P and HEA scale in order to verify the reliability of retest.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Depressive disorder group: The samples were from the outpatients and inpatients of Shanghai Mental Health Center and Shanghai Pudong New Area Mental Health Center from January 2020 to December 2020, and met DSM-5 diagnostic criteria. Sixty patients aged 1865 were enrolled in the group. Healthy control group: The sample comes from the healthy people recruited by the society who meet the entry criteria of the control group and match the gender, age and education level, and 60 cases are planned to be enrolled in the group.
Key inclusion criteria (8 listed)
- Case group:
- 1）did not meet the diagnostic criteria of any axis I in DSM-5. 2）18-65 years old, with junior high school education or above. 3）Willing to participate in this study, and the subjects signed the informed consent form.
Key exclusion criteria (2 listed)
- 1）severe drug allergy. 2）Suffering from some serious physical diseases adversely affects the validity of neuropsychological test data.
- 3）serious negative suicide concept.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment Emergent Symptom Scale TESS
Time frame: Up to 1 week
Common adverse drug reactions and signs were evaluated. The "severity" column was used to evaluate the severity level of symptoms from 0 to 4. The higher the severity level, the more serious the symptoms
The Frequency, Intensity, and Burden of Side Effects Rating, FIBSER
Time frame: Up to 4 week
Evaluate three areas of drug side effects through patient self-report and rank the drug impact: frequency (how many adverse reactions caused by depression drugs in the past week), intensity (how serious adverse reactions caused by depression drugs in the past week), and burden (how much adverse reactions caused by depression drugs affect your daily activities in the past week).
HEA Health Economics Follow-up Evaluation Form，HEA
Time frame: Up to 4 week
The main evaluation in the past month includes the following items: how many times have you seen a doctor (doctor), other medical personnel, whether you have been in hospital, and the number of days off due to depression and other diseases
Sheehan Disability Scale ，SDS
Time frame: Up to 1 week
Including three items, ask patients about the degree of damage caused by their current diseases/symptoms to their work, social interaction and family functions in turn; Visual simulation score of 0-10
Doctor-patient Relationship Scale-Patient Edition ，STAR-P Doctor-patient Relationship Scale-Patient Edition (STAR-P)
Time frame: Up to 4 week
The total score of STAR-P and the scores of three subscales are adopted: active collaboration (PCO: harmonious and shared understanding of goals and mutual open and trusted experiences), active clinician input (PCI: clinicians encourage, consider, support, listen and understand patients) and non-clinician input (NCI: patients can't understand clinicians), which is composed of 12 items
PDRQ-15 Scale
Time frame: Up to 1 week
There are 15 items in total, which are divided into three dimensions: patient/family satisfaction (6 items), accessibility of medical staff (7 items) and disease attitude of patients/family members.
3 secondary outcomes
HAM-D
Time frame: Up to 4 week
HAM-A
Time frame: Up to 4 week
YMRS
Time frame: Up to 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
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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.
Jun Chen, M.D., Ph.D principal investigator
Shanghai Mental Health Center
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 Depression, run by Shanghai Mental Health Center 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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Chen, M.D., Ph.D (021-34773367, doctorcj2010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Symptom Scale TESS (time frame: Up to 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2022.