A Study on the Outcome and Its Influencing Factors in Patients With Borderline Personality Disorder
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ClinicalTrials.gov Identifier: NCT06005779 |
Recruitment Status :
Active, not recruiting
First Posted : August 22, 2023
Last Update Posted : August 22, 2023
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Condition or disease |
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Borderline Personality Disorder |
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 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 |
- 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).
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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
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
China, Hubei | |
Wuhan Mental Health Centre | |
Wuhan, Hubei, China, 430014 |
Study Director: | Fan Yang, Master | Wuhan Mental Health Centre |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Personality Disorders Borderline Personality Disorder Mental Disorders |