NCT05381649

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

November 17, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2025

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

May 12, 2022

Last Update Submit

April 23, 2026

Conditions

Keywords

Cognitive empathyEmotional empathyMultifaceted empathy test

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

General adult psychiatry patients aged 18 to 65 whose primary diagnosis is EUPD.

You may qualify if:

  • 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

You may not qualify if:

  • Comorbid psychosis or learning disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Lothian

Livingston, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 19, 2022

Study Start

November 17, 2022

Primary Completion

November 28, 2025

Study Completion

November 28, 2025

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations