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A Study on the Outcome and Its Influencing Factors in Patients With Borderline Personality Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06005779
Recruitment Status : Active, not recruiting
First Posted : August 22, 2023
Last Update Posted : August 22, 2023
Sponsor:
Information provided by (Responsible Party):
Wuhan Mental Health Centre

Study Description
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Brief Summary:
Borderline personality disorder (BPD) is a difficult chronic mental illness. This diagnosis is common in Western countries. Our researchers want to study the outcome and its influencing factors of BPD for the first time in China. Patients with BPD who had been hospitalized in Wuhan Mental Health Center were selected as the subjects. The researchers retrospectively collected the most recent hospitalization data of these patients, and then prospectively follow up them for 2 years to see how their condition will change. By analyzing all data, researchers hope to know deeply about the development law of this illness, and to provide evidence for releasing these patients' suffering.

Condition or disease
Borderline Personality Disorder

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 Design
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Study Type : Observational
Estimated Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: An Ambispective Cohort Study on the Prognosis and Its Influencing Factors of Borderline Personality Disorder
Actual Study Start Date : October 22, 2021
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
    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).


Secondary Outcome Measures :
  1. 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. ]
    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.

  2. 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. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inpatients at the Wuhan Mental Health Center
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06005779


Locations
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China, Hubei
Wuhan Mental Health Centre
Wuhan, Hubei, China, 430014
Sponsors and Collaborators
Wuhan Mental Health Centre
Investigators
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Study Director: Fan Yang, Master Wuhan Mental Health Centre
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Wuhan Mental Health Centre
ClinicalTrials.gov Identifier: NCT06005779    
Other Study ID Numbers: KY2018.77
First Posted: August 22, 2023    Key Record Dates
Last Update Posted: August 22, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders