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CompletedNCT05831852Updated Sep 7, 2023

Screening of the Possible Risk Factors for Borderline Personality Disorders and Validation of Maclean Instrument

An observational study in Borderline Personality Disorder, sponsored by October University for Modern Sciences and Arts. Completed at 1 site in Egypt. Open to participants aged 18 Years to 28 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by October University for Modern Sciences and Arts · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 28 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Borderline Personality Disorder

Keywords

  • BPD
  • Maclean instrument
  • validation
  • risk factors
03

In context

Personality Disorders

336 studies on the registry are indexed under Personality Disorders; 48 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 88 observational studies indexed under Personality Disorders.

Browse Personality Disorders studies →

Lead sponsor

October University for Modern Sciences and Arts is the lead sponsor of 50 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 28 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

adults

Inclusion criteria

  • age group (18-28 years old )
  • University students

Exclusion criteria

Exclusion Criteria:

  • less than 18 years old
  • more than 28 years old
05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • one group

    Other: no intervention

Interventions

  • Otherno intervention

    no intervention

06

What researchers measure

Primary outcomes

  1. validation of Arabic version of Maclean Instrument

    detection of reliability and consistency

    Time frame: 6 months

  2. Detection of Borderline personality disorder Risk factors in Egyptians students

    survey

    Time frame: 6 months

07

Study locations

1 site
  • October University for modern sciences and arts
    Giza, Egypt
08

References and documents

Publications

  • Dias DS, Natividade JC. Brazilian adaptation of the McLean Screening Instrument for Borderline Personality Disorder. Trends Psychiatry Psychother. 2024;46:e20220486. doi: 10.47626/2237-6089-2022-0486. Epub 2022 Oct 18. PubMed 36257605 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05831852
Lead sponsor
October University for Modern Sciences and Arts
Responsible party
Sara ElAdawy (lecturer of clinical pharmacy, October University for Modern Sciences and Arts) — Principal investigator
First posted
Apr 26, 2023
Start date
May 1, 2023
Primary completion
Sep 1, 2023
Completion
Sep 1, 2023
Last update
Sep 7, 2023

Study contacts

sara Eladawy, PhD
principal investigator · MSA university
mohamed hafez
study director · biostatistician, biomedical informatics medical research institute Alexandria University
mohamed emad
study chair · biostatistician, biomedical informatics, medical research institute, Alexandria University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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