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

Active, not recruiting

• Conditions: Borderline Personality Disorder

• Registration Number: NCT06005779
• Lead Sponsor: Wuhan Mental Health Centre

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.

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 Timeline

• Study Start: 2021-10-22
• Status Verified: 2023-08
• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-15
• Last Update Submitted: 2023-08-15
• Study First Posted: 2023-08-22
• Last Update Posted: 2023-08-22
• Primary Completion: 2024-08
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
remission rate	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

Name	Time	Method
quality of life	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.
social disability	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.

Trial Locations

Locations (1)

Wuhan Mental Health Centre; 🇨🇳 Wuhan, Hubei, China