PEGASUS - Improving Treatment for Patients With Emotionally Unstable Personality Disorder
NCT Number: NCT06563466
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Borderline Personality Disorder|Relatives
Interventions: OTHER: The experimental intervention PEGASUS|OTHER: Treatment as usual
Sponsor: Mental Health Services in the Capital Region, Denmark
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-08-31
Locations: Copenhagen Research Center for Mental Health - CORE, Copenhagen, 2900, Denmark

Summary:
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

Primary Outcome Measures: Level of functioning, WHODAS 2.0, 36-item interviewer-administered version (WHO's Disability Assessment Schedule). Measured in patients., Study inclusion and at 9 months at study completion
Secondary Outcome Measures: 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., Study inclusion and at 9 months at study completion|Presences of suicidal ideations, Evaluated by the Suicidal Ideation Attributes Scale (SIDAS) and patient records. Measured in patients., Study inclusion and at 9 months at study completion|Well-being, Measured using WHO-5 (WHO-5 Questionnaires and Symptom Checklist 10 (SCL-10). Measured in patients and participating relatives., Study inclusion and at 9 months at study completion|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., Study inclusion and at 9 months at study completion|Ability to apply therapeutic tools learnt in therapy to everyday life situations., The Dialectical Behavior Therapy Ways of Coping Checklist, Danish version (DBT-WCCL). Measured in patients and participating relatives., At study inclusion and 9 months later at study conclusion|Perceived burden by relatives, Evaluated by the relatives answering the Burden Assessment Scale (BAS). Measured only in relatives., Study inclusion and at 9 months at study completion|Satisfaction and acceptability of treatment, Measured with Client Satisfaction Questionnaire (CSQ)18, Process of Recovery Questionnaire (QPR)19 and Negative Effects questionnaire. As well as measuring treatment attendance and completion of the program. Measured in patients and participating relatives., At study conclusion|Patient Recorded Outcome Measures (PROM), Data from the local "Treatment Effect" database (Dansk: "Behandlingseffekt"). Including: Brief INSPIRE-O, Sheehan's Disability Scale (SDS), Level of Personality Functioning Scale Brief From 2.0 (LPFS BF 2.0)., Study inclusion and at 9 months at study completion. Measured in patients