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

Borderline Personality Disorder Clinical Trial

Official title:

An Ambispective Cohort Study on the Prognosis and Its Influencing Factors of Borderline Personality Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06005779
• Other study ID #: KY2018.77
• Status: Active, not recruiting
• Start date: October 22, 2021
• Est. completion date: September 2024

Study information

• Verified date: August 2023
• Source: Wuhan Mental Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 270
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Locations

Country	Name	City	State
China	Wuhan Mental Health Centre	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Mental Health Centre

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	remission rate	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).	After the first follow-up, patients will be followed up every 6 months, and the total follow-up time was 2 years.
Secondary	social disability	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.	After the first follow-up, patients will be followed up every 6 months, and the total follow-up time was 2 years.
Secondary	quality of life	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.	After the first follow-up, patients will be followed up every 6 months, and the total follow-up time was 2 years.