Borderline Personality DisorderNCT05831852
Screening of the Possible Risk Factors for Borderline Personality Disorders and Validation of Maclean Instrument
An observational study of Borderline Personality Disorder, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: adults
Who may be able to join
- age group (18-28 years old )
- University students
Who cannot join
- less than 18 years old
- more than 28 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- Borderline Personality Disorder
- Being tested
- no intervention
- Keywords
- BPD, Maclean instrument, validation, risk factors
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| one group | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
validation of Arabic version of Maclean Instrument
detection of reliability and consistency
Measured: 6 months
Detection of Borderline personality disorder Risk factors in Egyptians students
survey
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 May 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara ElAdawy, October University for Modern Sciences and Arts
- Investigators
- sara Eladawy, PhD, Principal investigator, MSA universitymohamed hafez, Study director, biostatistician, biomedical informatics medical research institute Alexandria Universitymohamed emad, Study chair, biostatistician, biomedical informatics, medical research institute, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831852
- Sponsor's protocol ID
- RSPL 2.2
- Status last verified
- Sep 2023
- First submitted
- 16 Apr 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 "
- ClinicalTrials.gov ID
- NCT05831852
- Acronym / sponsor ID
- RSPL 2.2
- Conditions
- Borderline Personality Disorder
- Keywords
- BPD, Maclean instrument, validation, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group | – | Other: no intervention |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- adults
Key inclusion criteria (2 listed)
- age group (18-28 years old )
- University students
Key exclusion criteria (2 listed)
- less than 18 years old
- more than 28 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | one group |
Primary outcome
validation of Arabic version of Maclean Instrument
Time frame: 6 months
detection of reliability and consistency
Detection of Borderline personality disorder Risk factors in Egyptians students
Time frame: 6 months
survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Results publication: PubMed 36257605Dias 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Personality Disorder, run by October University for Modern Sciences and Arts at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validation of Arabic version of Maclean Instrument (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05831852, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.