Emotionally Unstable Personality Disorder, Borderline TypeNCT05381649
Empathy Anomalies in Emotionally Unstable (Borderline) Personality Disorder
An observational study of Emotionally Unstable Personality Disorder, Borderline Type, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Emotionally unstable (borderline) personality disorder (BPD) is characterised by changeable and extreme emotions and difficulty maintaining relationships. It is often associated with self-harm. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emotionally Unstable Personality Disorder, Borderline Type
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Nov 2022to 28 Nov 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General adult psychiatry patients aged 18 to 65 whose primary diagnosis is EUPD.
Who may be able to join
- General adult psychiatry patients aged 18 to 65
- Primary diagnosis is EUPD, as per ICD-11 criteria (World Health Organisation - International Classification of Diseases for Mortality and Morbidity Statistics)
- Able to speak and read English
- Able to provide informed consent
Who cannot join
- Comorbid psychosis or learning disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empathy Anomalies in Emotionally Unstable (Borderline) Personality Disorder - Prospective, Longitudinal, Cohort Study
Emotionally unstable (borderline) personality disorder (BPD) is characterised by changeable and extreme emotions and difficulty maintaining relationships. It is often associated with self-harm.
Empathy has two components; cognitive empathy (imagining someone else's thoughts and feelings) and emotional empathy (the reciprocal emotional response). People with BPD score low on cognitive empathy but high on emotional empathy. This suggests that they do not easily understand other peoples' perspectives, but their own emotions are very sensitive. This is important because it could align BPD with other neurodiverse conditions.
Read more
This study will use a computer-based empathy test and short questionnaires to investigate whether empathy changes during the course of BPD, and if the severity of empathy impairments correlate with severity. The tests are the multifaceted empathy test (MET) and the questionnaire of cognitive and affective empathy (QCAE).
The MET requires participants to look at photographs of emotive faces, then choose the most appropriate adjective. It takes 30 minutes to complete. The QCAE asks 31 questions like 'it is hard for me to see why some things upset people'.
Participants will be invited to join the study when they are diagnosed with BPD. Severity will be measured with the Borderline Symptom List 23, a disability questionnaire, and the number of self-harming episodes per month, the number of hospital assessments per month and the number of hospital admissions per month. Short NHS questionnaires of anxiety, depression and mood will also be completed, along with short reading test.
About 30 participants will be assessed 4 times over 2 years.
Read the detailed description
Emotionally unstable personality disorder (EUPD) is a mental disorder characterised by a pervasive pattern of emotion dysregulation, inconsistent identity, and difficulties with interpersonal functioning. It is often associated with deliberate self-harm, has a high burden on affected individuals, family members, and health-care systems, and is associated with low occupational and educational attainment, lack of long-term relationships, increased partner conflict, low life satisfaction, and increased statutory service use.
Recently, an impaired ability to understand other people's motives and perceptions ('mind read' or empathise) has been shown to be characteristic of EUPD.
Empathy has two components; cognitive empathy (the ability to imagine someone else's thoughts and feelings) and emotional empathy (the reciprocal emotional response). People with EUPD score low on measures of cognitive empathy and high on measures of emotional empathy compared to non-clinical controls. This suggests that they do not easily understand other peoples' perspectives, but their own emotions are especially sensitive.
Healthcare services need outcome measures and predictors of treatment response to develop evidence-based guidelines for EUPD. Hence, this study will use a computer-based empathy assessment tool and short questionnaires to investigate whether empathy changes during the course of EUPD, and if the extent of an empathy impairment correlates with syndrome severity.
Many of the established empathy tests only elicit severe empathy anomalies, produce results that do not translate into real life scenarios, do not describe cognitive and emotional empathy separately, or are cumbersome so not routinely applicable. However, the empathy test this study will use (multifaceted empathy test or MET) has been shown to quantify the EUPD empathy anomaly, is ecologically valid, does not require training to administer, can be gone through in 30 minutes in a clinic room, and has NHS IT security clearance. The empathy questionnaire that will be used (questionnaire of cognitive and affective empathy or QCAE) is an amalgam of other validated questionnaires which improves on their limitations but is still concise (31 questions in total).
The MET requires participants to look at several photographs of emotive faces, then choose the most appropriate adjective. The QCAE asks 31 questions like 'it is hard for me to see why some things upset people so much'. To ensure that performance is not skewed by reading ability, participants will be asked to complete the National Adult Reading Test questionnaire (NART). This only takes a few minutes to complete and is used routinely in NHS clinical practice.
Participants will be invited to join the study when they are diagnosed with EUPD in consultant psychiatry outpatient appointments. Syndrome severity will be measured with the Borderline Symptom List 23 (BSL 23) which is self-rated and takes only a few minutes to complete. Clinical indicators of syndrome severity will be the number of self-harming episodes per month, the number of hospital assessments per month and the number of hospital admissions per month. The World Health Organization Disability Assessment Schedule (WHODAS) will be used to describe any pervasive functional impairment.
The self-rated Hamilton Anxiety Rating Scale (HAM-A) and Patient Health Questionnaire 9 (PHQ-9) will describe any concurrent anxious and depressive symptoms, and the Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) will describe mood. These also only takes a few minutes to complete and are used routinely in NHS clinical work.
It is anticipated that about 30 participants will be required because similar studies produced significant results with about that number. Participants will be assessed at baseline, after 6 months, 1 year, and 18 months. This should be long enough because the established psychological therapies for EUPD take about this long.
- Keywords
- Cognitive empathy, Emotional empathy, Multifaceted empathy test
What is being measured
The primary outcome is the main question the study is designed to answer.
Do empathy scores correlate significantly with emotionally unstable personality disorder syndrome severity?
Spearman's correlation-coefficient will be used to analyse any correlation between empathy scores and syndrome severity. ANOVA will be used when multiple comparisons are made.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start17 Nov 2022
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotionally Unstable Personality Disorder, Borderline TypeStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381649
- Sponsor's protocol ID
- 310008
- Status last verified
- Apr 2026
- First submitted
- 12 May 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empathy Anomalies in Emotionally Unstable (Borderline) Personality Disorder - Prospective, Longitudinal, Cohort Study
- ClinicalTrials.gov ID
- NCT05381649
- Acronym / sponsor ID
- 310008
- Keywords
- Cognitive empathy, Emotional empathy, Multifaceted empathy test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 19 May 2022 (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.
Emotionally unstable (borderline) personality disorder (BPD) is characterised by changeable and extreme emotions and difficulty maintaining relationships. It is often associated with self-harm.
Empathy has two components; cognitive empathy (imagining someone else's thoughts and feelings) and emotional empathy (the reciprocal emotional response). People with BPD score low on cognitive empathy but high on emotional empathy. This suggests that they do not easily understand other peoples' perspectives, but their own emotions are very sensitive. This is important because it could align BPD with other neurodiverse conditions.
This study will use a computer-based empathy test and short questionnaires to investigate whether empathy changes during the course of BPD, and if the severity of empathy impairments correlate with severity. The tests are the multifaceted empathy test (MET) and the questionnaire of cognitive and affective empathy (QCAE).
The MET requires participants to look at photographs of emotive faces, then choose the most appropriate adjective. It takes 30 minutes to complete. The QCAE asks 31 questions like 'it is hard for me to see why some things upset people'.
Participants will be invited to join the study when they are diagnosed with BPD. Severity will be measured with the Borderline Symptom List 23, a disability questionnaire, and the number of self-harming episodes per month, the number of hospital assessments per month and the number of hospital admissions per month. Short NHS questionnaires of anxiety, depression and mood will also be completed, along with short reading test.
About 30 participants will be assessed 4 times over 2 years.
Detailed description
Emotionally unstable personality disorder (EUPD) is a mental disorder characterised by a pervasive pattern of emotion dysregulation, inconsistent identity, and difficulties with interpersonal functioning. It is often associated with deliberate self-harm, has a high burden on affected individuals, family members, and health-care systems, and is associated with low occupational and educational attainment, lack of long-term relationships, increased partner conflict, low life satisfaction, and increased statutory service use.
Recently, an impaired ability to understand other people's motives and perceptions ('mind read' or empathise) has been shown to be characteristic of EUPD.
Empathy has two components; cognitive empathy (the ability to imagine someone else's thoughts and feelings) and emotional empathy (the reciprocal emotional response). People with EUPD score low on measures of cognitive empathy and high on measures of emotional empathy compared to non-clinical controls. This suggests that they do not easily understand other peoples' perspectives, but their own emotions are especially sensitive.
Healthcare services need outcome measures and predictors of treatment response to develop evidence-based guidelines for EUPD. Hence, this study will use a computer-based empathy assessment tool and short questionnaires to investigate whether empathy changes during the course of EUPD, and if the extent of an empathy impairment correlates with syndrome severity.
Many of the established empathy tests only elicit severe empathy anomalies, produce results that do not translate into real life scenarios, do not describe cognitive and emotional empathy separately, or are cumbersome so not routinely applicable. However, the empathy test this study will use (multifaceted empathy test or MET) has been shown to quantify the EUPD empathy anomaly, is ecologically valid, does not require training to administer, can be gone through in 30 minutes in a clinic room, and has NHS IT security clearance. The empathy questionnaire that will be used (questionnaire of cognitive and affective empathy or QCAE) is an amalgam of other validated questionnaires which improves on their limitations but is still concise (31 questions in total).
The MET requires participants to look at several photographs of emotive faces, then choose the most appropriate adjective. The QCAE asks 31 questions like 'it is hard for me to see why some things upset people so much'. To ensure that performance is not skewed by reading ability, participants will be asked to complete the National Adult Reading Test questionnaire (NART). This only takes a few minutes to complete and is used routinely in NHS clinical practice.
Participants will be invited to join the study when they are diagnosed with EUPD in consultant psychiatry outpatient appointments. Syndrome severity will be measured with the Borderline Symptom List 23 (BSL 23) which is self-rated and takes only a few minutes to complete. Clinical indicators of syndrome severity will be the number of self-harming episodes per month, the number of hospital assessments per month and the number of hospital admissions per month. The World Health Organization Disability Assessment Schedule (WHODAS) will be used to describe any pervasive functional impairment.
The self-rated Hamilton Anxiety Rating Scale (HAM-A) and Patient Health Questionnaire 9 (PHQ-9) will describe any concurrent anxious and depressive symptoms, and the Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) will describe mood. These also only takes a few minutes to complete and are used routinely in NHS clinical work.
It is anticipated that about 30 participants will be required because similar studies produced significant results with about that number. Participants will be assessed at baseline, after 6 months, 1 year, and 18 months. This should be long enough because the established psychological therapies for EUPD take about this long.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General adult psychiatry patients aged 18 to 65 whose primary diagnosis is EUPD.
Key inclusion criteria (4 listed)
- General adult psychiatry patients aged 18 to 65
- Primary diagnosis is EUPD, as per ICD-11 criteria (World Health Organisation - International Classification of Diseases for Mortality and Morbidity Statistics)
- Able to speak and read English
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Comorbid psychosis or learning disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Do empathy scores correlate significantly with emotionally unstable personality disorder syndrome severity?
Time frame: 3 years
Spearman's correlation-coefficient will be used to analyse any correlation between empathy scores and syndrome severity. ANOVA will be used when multiple comparisons are made.
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 29 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Emotionally Unstable Personality Disorder, Borderline Type, run by University of Edinburgh at 1 site in United Kingdom.
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 4 inclusion and 1 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 29 Apr 2026. 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 United Kingdom. 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?
Do empathy scores correlate significantly with emotionally unstable personality disorder syndrome severity? (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.