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.