PEGASUS - Improving Treatment for Patients With Emotionally Unstable Personality Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Bispebjerg and Frederiksberg
About this trial
The purpose of the PEGASUS study is to conduct a pilot trial to test the feasibility and acceptability of the PEGASUS intervention, adding a case manager and family-based interventions meetings to the existing psychiatric integrated care-models known as "Treatment Packages" in Denmark. We will conduct a randomized, assessor-blinded parallel-groups superiority clinical trial, testing the PEGASUS intervention for emotionally unstable personality disorder "EUPD", borderline type (borderline personality disorder) compared to "Treatment as Usual" before moving on to testing in a full-scale trial. Participants will be assessed at baseline and 9 month post baseline at study conclusion
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Must be able to give an informed written consent.
Must be newly accepted in the pre-planned BPD treatment packages.
≥18 years of age.
Agreeing to involvement of one or two informal caregivers, families, or close friends ("Relatives").
Disqualifiers
None*
Note that to get accepted into a treatment package for BPD, patients must not fulfill the criteria for a F20 diagnosis or the criteria for alcohol or substance abuse or harmful use.
Must be able to give an informed written consent.
≥18 years of age.
Trial design
Design model
Parallel
Treatments tested in this trial
The experimental intervention PEGASUS
Other interventionSee arm description.
Treatment as usual
Other interventionSee arm description
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Treatment as usual (TAU)Active comparator 1 intervention
Group B: The experimental intervention PEGASUSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Level of functioning
WHODAS 2.0, 36-item interviewer-administered version (WHO's Disability Assessment Schedule). Measured in patients.
Time frame
Study inclusion and at 9 months at study completionSecondary outcomes
1
Symptom relief
Measured by: Symptoms assessed with semi structured interviews using the Zanarini rating scale for borderline personality disorder (ZAN-BPD) and the personality disorder severity ICD-11 (PDS-ICD-11) and self-report by the borderline Symptom List 23 (BSL-23). Measured in patients.
Time frame
Study inclusion and at 9 months at study completion2
Presences of suicidal ideations
Evaluated by the Suicidal Ideation Attributes Scale (SIDAS) and patient records. Measured in patients.
Time frame
Study inclusion and at 9 months at study completion3
Well-being
Measured using WHO-5 (WHO-5 Questionnaires and Symptom Checklist 10 (SCL-10). Measured in patients and participating relatives.
Time frame
Study inclusion and at 9 months at study completion4
Change in quality of relation between patient and relatives
Will be measured by using the Relationship Assessment scale General version (RAS-G). Measured in patients and participating relatives.
Time frame
Study inclusion and at 9 months at study completionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Bispebjerg and Frederiksberg
Lead sponsor
Hvidovre University Hospital
Collaborator
Source ClinicalTrials.gov