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

Sponsor
Wuhan Mental Health Centre (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06005779
Collaborator
(none)
270
1
34.3
7.9

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated 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 :
    Oct 22, 2021
    Anticipated Primary Completion Date :
    Aug 1, 2024
    Anticipated Study Completion Date :
    Sep 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Wuhan Mental Health Centre Wuhan Hubei China 430014

    Sponsors and Collaborators

    • Wuhan Mental Health Centre

    Investigators

    • Study Director: Fan Yang, Master, Wuhan Mental Health Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wuhan Mental Health Centre
    ClinicalTrials.gov Identifier:
    NCT06005779
    Other Study ID Numbers:
    • KY2018.77
    First Posted:
    Aug 22, 2023
    Last Update Posted:
    Aug 22, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2023