- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06005779
A Study on the Outcome and Its Influencing Factors in Patients With Borderline Personality Disorder
An Ambispective Cohort Study on the Prognosis and Its Influencing Factors of Borderline Personality Disorder
Study Overview
Status
Conditions
Detailed Description
This study is an ambispective cohort study. The information collected in the retrospective part mainly included demographic data, comorbid psychiatric diagnosis, psychotherapeutive and pharmacotherapeutive data, times of hospitalization and patients' contact information. The above data were derived from electronic medical records. After informed consent, prospective follow-up was initiated primarily by telephone interviews and web-based questionnaires, or by in-person assessments at hospital return visits. Enrolled patients will be followed up at 6-month intervals after the first follow-up to assess psychiatric diagnosis, social function, and quality of life. The researchers are senior psychiatrists, all of whom received training on the use of questionnaires and inter-investigator consistency before the follow-up.
Cox Proportional Hazard Model is used to analyze the influencing factors of remission of BPD, and Generalized Estimating Equation Model is used to analyze the influencing factors of the patients' social function and quality of life.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Hubei
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Wuhan, Hubei, China, 430014
- Wuhan Mental Health Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of BPD based on ICD-10 (F60.3)
Exclusion Criteria:
- Comorbidity with severe physical disease
- Comorbidity with neurological diseases such as epilepsy
- Comorbidity with mental retardation
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
remission rate
Time Frame: After the first follow-up, patients will be followed up every 6 months, and the total follow-up time was 2 years.
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The remission rate is calculated as the number of patients who no longer met the diagnostic criteria for BPD for at least 6 months divided by the total number of enrolled patients.
The diagnostic tool is ICD-10 (F60.3).
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After the first follow-up, patients will be followed up every 6 months, and the total follow-up time was 2 years.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
social disability
Time Frame: After the first follow-up, patients will be followed up every 6 months, and the total follow-up time was 2 years.
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Social disability refers to the patient's occupation, family, social life, personal life and other aspects of functional deficits, using Social Disability Screening Schedule (SDSS) to assess.
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After the first follow-up, patients will be followed up every 6 months, and the total follow-up time was 2 years.
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quality of life
Time Frame: After the first follow-up, patients will be followed up every 6 months, and the total follow-up time was 2 years.
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Someone's quality of life is the extent to which their life is comfortable or satisfying.
The study used WHOQOL-BREF to assess patients' quality of life in the physical, psychological, social relationship, and environmental domains.
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After the first follow-up, patients will be followed up every 6 months, and the total follow-up time was 2 years.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Fan Yang, Master, Wuhan Mental Health Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY2018.77
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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