An interventional study of The experimental intervention PEGASUS and Treatment as usual in Borderline Personality Disorder and Relatives, sponsored by University Hospital Bispebjerg and Frederiksberg. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by University Hospital Bispebjerg and Frederiksberg · Not applicable, Interventional, and Treatment
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
Background and rationale:
Unmet needs for patients diagnosed with emotionally unstable personality disorder (borderline personality disorder).
People with emotionally unstable personality disorder, borderline type, also known as borderline personality disorder (BPD) have substantial degrees of impairment (in educational, work, family, and social functioning) even after treatment, and they contribute very substantially to the burden of psychiatric disorders on a population level. When treatment in primary care is insufficient, these patients should be referred to psychiatric integrated care-models known as "treatment packages" in the secondary psychiatric healthcare sector. The treatment packages were introduced in Denmark in 2013. More than half of patients finishing a treatment package may still have symptoms, and it is also a clinical experience and hypothesis, that many patients will continue to receive more than one treatment package either for the same disorder or for different disorders. Furthermore, the level of functioning, particularly in BPD, often remains impaired despite symptomatic relief.
Family members are often both the first and the last line of defense, as they are the people whom the patient will contact 24/7, whenever there is an obstacle or a crisis related to the mental disorder. The lives of the family members are severely affected, as they may live in constant worry for their mentally ill relative, and they may need to be ready to throw everything else aside, when there is a crisis. Moreover, they will also often play the role as self-taught lawyers or case managers to help the patient to get the necessary treatment and to avoid severe social adversities.
Enhanced treatment, case management and involvement of families Over the last 25 years we have learned a great deal about the benefits of providing additional support for people with early psychosis. Our OPUS trial resulted in more than 40 publications, and has been highly cited (2700 citations, February 2023 (Web of Science)). We have learned from the OPUS trial, that prompt and skilled treatment for those with recent onset psychosis can improve health outcomes. The most important elements in the experimental OPUS-treatment were involvement of families and affiliation with a case manager. The results of the OPUS trial have been replicated in many countries, and there is now solid evidence for "Early Intervention Services", summarized in a meta-analysis and a recent Cochrane Review. A next obvious research question is, whether the same clinical approaches and treatment elements could be helpful for other mental health conditions. In a recent Australian study it was shown, that caregivers of young people with borderline personality features experience adversities similar to, or greater than, that reported by caregivers of young people with other severe illnesses. Currently, except from a single trial carried out with young people with BPD, and few trials investigating the effect of psychoeducation or group therapy with relatives, we lack an evidence base to know, if comparable comprehensive treatment packages can help the patients with BPD and their families.
Participants
We will recruit outpatients, who have been referred to the Psychotherapeutic Outpatient Department (POD), Mental Health Centre Glostrup, Mental Health Services of the Capital Region of Denmark. The patients must have been accepted in the treatment package for BPD. The patients will be able to bring 1-2 relatives to participate in the study.
Inclusion and written consent
Patients will be approached at their first meeting, after getting accepted into the treatment package program at POD. If interested, the patients will be scheduled for an inclusion meeting with a research assistant from the project, who is a trained physician. The inclusion meeting will take place uninterrupted in an office at the POD. Here participating patients will receive detailed written and oral information about participation, and give informed written consent.
In addition to this, the patient's relatives' experience of the PEGASUS intervention and TAU will be evaluated. The relatives' contact information will be obtained through the participating patients. They will be contacted by phone to schedule an inclusion meeting. The inclusion meeting will take place by phone call, where the relatives will receive detailed information about study participation and sign a digital version of the written consent.
The participants can withdraw their consent at any time during or after the study.
Assessment
We will be collecting data at inclusion to the study and at study conclusion after 9-month treatment. An additional follow up is under consideration, but not scheduled. Assessment will be conducted by semi structured interviews, questionnaires, collecting data from patient records and register based data from the Danish registers.
Calculation of sample size and analysis
In the main trial, we will have 90% power to detect a relevant difference of 7.2 (SD 19.2) on the WHODAS, which will require 2*150=300 participants with BPD. Based on this number of participants, it will be necessary to carry out a pilot trial with 15-20 participants in each arm. We will analyze all outcomes for safety and satisfaction. As per pilot trial guidelines, we will assess nominal differences regarding safety and acceptability. Safety will be defined through potential side effects, and whether the intervention group appears to get worse over time.
278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 221 interventional studies indexed under Borderline Personality Disorder.
Browse Borderline Personality Disorder studies →University Hospital Bispebjerg and Frederiksberg is the lead sponsor of 69 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participating Patients
Inclusion Criteria:
Exclusion Criteria:
None*
Participating Relatives:
Inclusion Criteria:
Exclusion criteria: None
Patients with BPD are offered group-based treatment and individual therapy according to the standardized healthcare delivery models, known as the "psychiatric treatment package" for borderline personality disorder. The treatment package complies with the description agreed upon in common documents endorsed by all Danish Regions. The content of the treatment package includes psychotherapeutic treatment, according to the evidence based diagnose-specific manuals, and consultations with a psychiatrist. In this study this specifically includes, a treatment program consisting of dialectic behavioral treatment (DBT), delivered according to the manuals by Linehan, 1993 and Linehan, 2015.
Other: Treatment as usual
Patients in PEGASUS will, in addition to TAU, be offered to be affiliated with a case manager and to have their families involved in family-based interventions. Duration of the intervention will be nine months. The case manager will be a trained professional, who will be able to be a guiding figure and when needed, be able to help the patient contacting different authorities. The case manager can support the patient in solving everyday life problems, and will be an occupational therapist, a nurse, or a social worker. The case manager will offer the patients nine extra individual sessions during their treatment course. The format of the family-based interventions will be two psychoeducational workshops with 6 to 8 families invited and six multifamily group meetings, in which the patient and one or two relatives can participate. Theories behind Psychoeducational Multifamily Groups, Compassion Cultivation Training and Family Connections (FC, Hoffman et al., 2007) will be drawn upon.
Other: The experimental intervention PEGASUS
See arm description.
Also known as: Case Manager, Family-based interventions
See arm description
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 completion
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 completion
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 completion
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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Study inclusion and at 9 months at study completion. Measured in patients
Plan to share: Yes — Available upon request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: After publication
Access criteria: Upon request
Started Sep 2024 (actual). Primary completion is estimated for Oct 2027, 37 months after the start.
Of 105 non-industry interventional studies with no phase under Borderline Personality Disorder, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 54. This study's planned 37 months is close to that.
Counting every sponsor, half of 107 studies reached it within 35 months; a quarter within 24 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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