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临床试验/NCT06005779
NCT06005779进行中(未招募)不适用

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

Wuhan Mental Health Centre1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2021年10月22日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
270
试验地点
1
主要终点
remission rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of BPD based on ICD-10 (F60.3)

排除标准

  • Comorbidity with severe physical disease
  • Comorbidity with neurological diseases such as epilepsy
  • Comorbidity with mental retardation

结局指标

主要结局

remission rate

时间窗: 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).

次要结局

  • 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.)
  • social disability(After the first follow-up, patients will be followed up every 6 months, and the total follow-up time was 2 years.)

研究者

发起方
Wuhan Mental Health Centre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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