- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05831852
Screening of the Possible Risk Factors for Borderline Personality Disorders and Validation of Maclean Instrument
September 3, 2023 updated by: Sara ElAdawy, October University for Modern Sciences and Arts
Screening of the Possible Risk Factors for Borderline Personality Disorders Using Validated Arabic Version of Maclean Screening Tool: A Study in the Egyptian University Students "
Borderline personality disorder is a mental illness that severely impacts a person's ability to regulate their emotions.
This loss of emotional control can increase impulsivity, affect how a person feels about themselves, and negatively impact their relationships with others.
In fact, the societal impact of BPDs might be found in emotional suffering, disability and economic burden.
In addition in BPD, the suicide rate might be as high as 8-10%.
the presence of BPD also interferes with response to treatment of physical and psychiatric comorbidities, such as migraine, HIV, anxiety disorders and substance use disorders.
Furthermore, BPD in particular, are associated with high rates of unemployment, absences from work and inefficiency at work, with only 25% of patients suffering from BPD working full time and 40% receiving disability payments.
Accordingly, early detection and management would be of great societal and economic impact.
Our Study aim is to validate the Arabic version of Maclean Instrument for screening and detection of BPD and and investigate the possible risk factors associated with that disease
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Borderline personality disorder (BPD) is a mental health problem that affects the way you feel about yourself and others, the way you think , difficulty in managing behavior and emotions, self-image issues and a pattern of relationships that are unstable.
BPD patients frequently describe their life as unpredictable and stressful.
As stated in the Diagnostic and Statistical Manual of Mental Disorders (5th ed.), borderline personality disorder (BPD) is a serious mental illness characterized by a pervasive pattern of instability in interpersonal relationships, self-image and effect, as well as marked impulsivity.
This condition arises in early adulthood or adolescence, leading to severe functional impairment and subjective discomfort.
Unfortunately, diagnosis and treatment of BPD is often delayed, leading to a less favorable outcome.
This is especially true in patients with early onset BPD, in whom the detection and subsequent therapeutic intervention on the disorder is usually further put off.
Indeed, in the last two decades, there has been a great sensibilization towards personality disorder (PD)diagnosis in adolescence, reflected in the significant increase in empirical studies regarding this matter, and in the legitimization of adolescent PD diagnosis in psychiatric nomenclature (DSM-5 and ICD-11), as well as in national treatment guidelines in the UK and Australia.
Nonetheless, a recent review by Sharp has stressed how scientific evidence and national practice guidelines are yet to penetrate routine clinical care.
Indeed, in common clinical practice diagnosis and consequently, treatment of BPD is usually delayed due to underestimation of symptoms and, often, hesitation to diagnose this disorder in younger individuals.
BPD is progressively considered a life expectancy formative disorder that exists on a layered continuum of severity.
The recent studies for the adults who have BDP disease couldn't find a pharmacological treatment for them.
The symptoms treatment with pharmacotherapy is not accurate for the treatment of BDP in adults, the pharmacotherapy should not be used for adolescent BPD.
The only study exist is about the using of omega-3 fatty acids and the increase risk of psychosis.
Overall, there is no pharmacological treatment for the BDP disease for adults, also the risks of iatrogenic and poly-pharmacy toxicity is high in these young people.
The other comorbidities of the disease are treated from the clinical for adolescents, using the pharmacological therapy when needed.
Our study aim is to validate the Arabic version of Maclean Instrument for screening and detection of BPD and and investigate the possible risk factors associated that disease thus decreasing the societal and economic burden of that disease
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Giza, Egypt
- October University for Modern Sciences and Arts
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
adults
Description
Inclusion Criteria:
- age group (18-28 years old )
- University students
Exclusion Criteria:
- less than 18 years old
- more than 28 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
one group
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
validation of Arabic version of Maclean Instrument
Time Frame: 6 months
|
detection of reliability and consistency
|
6 months
|
Detection of Borderline personality disorder Risk factors in Egyptians students
Time Frame: 6 months
|
survey
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: sara Eladawy, PhD, MSA University
- Study Director: mohamed hafez, biostatistician, biomedical informatics medical research institute Alexandria University
- Study Chair: mohamed emad, biostatistician, biomedical informatics, medical research institute, Alexandria University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Actual)
September 1, 2023
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
April 16, 2023
First Submitted That Met QC Criteria
April 16, 2023
First Posted (Actual)
April 26, 2023
Study Record Updates
Last Update Posted (Actual)
September 7, 2023
Last Update Submitted That Met QC Criteria
September 3, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RSPL 2.2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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