Borderline Personality DisorderNCT06563466
PEGASUS - Improving Treatment for Patients With Emotionally Unstable Personality Disorder
A study testing The experimental intervention PEGASUS and Treatment as usual in people with Borderline Personality Disorder and Relatives, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder, Relatives
- What is being tested?
- The experimental intervention PEGASUS and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2024to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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").
- Capable of reading and understanding Danish.
- Must be able to give an informed written consent.
- ≥18 years of age.
- Capable of reading and understanding Danish.
Who cannot join
- 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.
- Participating Relatives:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen Research Center for Mental Health - CORE
Copenhagen, 2900
Ditte H. Rotvig, MD, +45 31154887, ditte.hoeyer.rotvig@regionh.dk
merete.nordentoft@regionh.dk
About this study
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
Read the detailed description
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.
- Conditions
- Borderline Personality Disorder, Relatives
- Being tested
- The experimental intervention PEGASUS, Treatment as usual
- Keywords
- Borderline Personality Disorder, Relatives, Group psychotherapy, Case management, Psychoeducation, Family, Caregiver
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The experimental intervention PEGASUSOther
Also called Case Manager, Family-based interventions
See arm description.
Treatment as usualOther
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual (TAU) | Active comparator | 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. Receives: Other: Treatment as usual |
| The experimental intervention PEGASUS | Experimental | 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. Receives: Other: The experimental intervention PEGASUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of functioning
WHODAS 2.0, 36-item interviewer-administered version (WHO's Disability Assessment Schedule). Measured in patients.
Measured: Study inclusion and at 9 months at study completion
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Study inclusion and at 9 months at study completion. Measured in patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Sep 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We have planned a single blinded randomized controlled trial (RCT) pilot study. The group of participating patients and their participating relatives will be randomized into treatment as usual (TAU) or to receive the additional PEGASUS intervention, and we will be comparing the two groups. The randomization will be made 1:1 and created in the randomization module in REDCap with a block-size unknown to the assessors. Since we are conducting a pilot study, sample size is small, and we won't be able to create a stratified randomization.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Carsten Hjorthøj, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Carsten Hjorthøj, Ph.d., Principal investigator, Copenhagen Research Center for Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563466
- Sponsor's protocol ID
- PEGASUS EUPD
- Other IDs
- 3166-00026B
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request.
Publications
Leichsenring F, Heim N, Leweke F, Spitzer C, Steinert C, Kernberg OF. Borderline Personality Disorder: A Review. JAMA. 2023 Feb 28;329(8):670-679. doi: 10.1001/jama.2023.0589.
PubMed 36853245Hastrup LH, Kongerslev MT, Simonsen E. Low Vocational Outcome Among People Diagnosed With Borderline Personality Disorder During First Admission to Mental Health Services in Denmark: A Nationwide 9-Year Register-Based Study. J Pers Disord. 2019 Jun;33(3):326-340. doi: 10.1521/pedi_2018_32_344. Epub 2018 Mar 5.
PubMed 29505387Reinholt N, Hvenegaard M, Christensen AB, Eskildsen A, Hjorthoj C, Poulsen S, Arendt MB, Rosenberg NK, Gryesten JR, Aharoni RN, Alro AJ, Christensen CW, Arnfred SM. Transdiagnostic versus Diagnosis-Specific Group Cognitive Behavioral Therapy for Anxiety Disorders and Depression: A Randomized Controlled Trial. Psychother Psychosom. 2022;91(1):36-49. doi: 10.1159/000516380. Epub 2021 Jun 10.
PubMed 34111874McMain SF, Guimond T, Streiner DL, Cardish RJ, Links PS. Dialectical behavior therapy compared with general psychiatric management for borderline personality disorder: clinical outcomes and functioning over a 2-year follow-up. Am J Psychiatry. 2012 Jun;169(6):650-61. doi: 10.1176/appi.ajp.2012.11091416.
PubMed 22581157Muscroft J, Bowl R. The impact of depression on caregivers and other family members: Implications for professional support. http://dx.doi.org/101080/09515070050011105 2010; 13: 117-34.
Senaratne R, Van Ameringen M, Mancini C, Patterson B. The burden of anxiety disorders on the family. J Nerv Ment Dis. 2010 Dec;198(12):876-80. doi: 10.1097/NMD.0b013e3181fe7450.
PubMed 21135638Lawn S, McMahon J. Experiences of family carers of people diagnosed with borderline personality disorder. J Psychiatr Ment Health Nurs. 2015 May;22(4):234-43. doi: 10.1111/jpm.12193. Epub 2015 Apr 8.
PubMed 25857849Petersen L, Jeppesen P, Thorup A, Abel MB, Ohlenschlaeger J, Christensen TO, Krarup G, Jorgensen P, Nordentoft M. A randomised multicentre trial of integrated versus standard treatment for patients with a first episode of psychotic illness. BMJ. 2005 Sep 17;331(7517):602. doi: 10.1136/bmj.38565.415000.E01. Epub 2005 Sep 2.
PubMed 16141449Correll CU, Galling B, Pawar A, Krivko A, Bonetto C, Ruggeri M, Craig TJ, Nordentoft M, Srihari VH, Guloksuz S, Hui CLM, Chen EYH, Valencia M, Juarez F, Robinson DG, Schooler NR, Brunette MF, Mueser KT, Rosenheck RA, Marcy P, Addington J, Estroff SE, Robinson J, Penn D, Severe JB, Kane JM. Comparison of Early Intervention Services vs Treatment as Usual for Early-Phase Psychosis: A Systematic Review, Meta-analysis, and Meta-regression. JAMA Psychiatry. 2018 Jun 1;75(6):555-565. doi: 10.1001/jamapsychiatry.2018.0623.
PubMed 29800949Puntis S, Minichino A, De Crescenzo F, Cipriani A, Lennox B, Harrison R. Specialised early intervention teams for recent-onset psychosis. Cochrane Database Syst Rev. 2020 Nov 2;11(11):CD013288. doi: 10.1002/14651858.CD013288.pub2.
PubMed 33135811Seigerman MR, Betts JK, Hulbert C, McKechnie B, Rayner VK, Jovev M, Cotton SM, McCutcheon L, McNab C, Burke E, Chanen AM. A study comparing the experiences of family and friends of young people with borderline personality disorder features with family and friends of young people with other serious illnesses and general population adults. Borderline Personal Disord Emot Dysregul. 2020 Jul 22;7:17. doi: 10.1186/s40479-020-00128-4. eCollection 2020.
PubMed 32704374Chanen AM, Betts JK, Jackson H, Cotton SM, Gleeson J, Davey CG, Thompson K, Perera S, Rayner V, Andrewes H, McCutcheon L. Effect of 3 Forms of Early Intervention for Young People With Borderline Personality Disorder: The MOBY Randomized Clinical Trial. JAMA Psychiatry. 2022 Feb 1;79(2):109-119. doi: 10.1001/jamapsychiatry.2021.3637.
PubMed 34910093Bateman A, Fonagy P. A randomized controlled trial of a mentalization-based intervention (MBT-FACTS) for families of people with borderline personality disorder. Personal Disord. 2019 Jan;10(1):70-79. doi: 10.1037/per0000298. Epub 2018 Jul 12.
PubMed 29999394Pearce J, Jovev M, Hulbert C, McKechnie B, McCutcheon L, Betts J, Chanen AM. Evaluation of a psychoeducational group intervention for family and friends of youth with borderline personality disorder. Borderline Personal Disord Emot Dysregul. 2017 Mar 24;4:5. doi: 10.1186/s40479-017-0056-6. eCollection 2017.
PubMed 28352470Grenyer BFS, Bailey RC, Lewis KL, Matthias M, Garretty T, Bickerton A. A Randomized Controlled Trial of Group Psychoeducation for Carers of Persons With Borderline Personality Disorder. J Pers Disord. 2019 Apr;33(2):214-228. doi: 10.1521/pedi_2018_32_340. Epub 2018 Mar 5.
PubMed 29505385
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEGASUS - Improving Treatment for Patients With Emotionally Unstable Personality Disorder
- ClinicalTrials.gov ID
- NCT06563466
- Acronym / sponsor ID
- PEGASUS EUPD
- Conditions
- Borderline Personality Disorder, Relatives
- Keywords
- Borderline Personality Disorder, Relatives, Group psychotherapy, Case management, Psychoeducation, Family, Caregiver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We have planned a single blinded randomized controlled trial (RCT) pilot study. The group of participating patients and their participating relatives will be randomized into treatment as usual (TAU) or to receive the additional PEGASUS intervention, and we will be comparing the two groups. The randomization will be made 1:1 and created in the randomization module in REDCap with a block-size unknown to the assessors. Since we are conducting a pilot study, sample size is small, and we won't be able to create a stratified randomization.
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) | Active comparator | Other: Treatment as usualPatients 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. |
| The experimental intervention PEGASUS | Experimental | Other: The experimental intervention PEGASUSPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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").
- Capable of reading and understanding Danish.
Key exclusion criteria (3 listed)
- None*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The experimental intervention PEGASUSAlso: Case Manager, Family-based interventionsSee arm description. | Other | The experimental intervention PEGASUS |
| Treatment as usualSee arm description | Other | Treatment as usual (TAU) |
Primary outcome
Level of functioning
Time frame: Study inclusion and at 9 months at study completion
WHODAS 2.0, 36-item interviewer-administered version (WHO's Disability Assessment Schedule). Measured in patients.
8 secondary outcomes
Symptom relief
Time frame: Study inclusion and at 9 months at study completion
Presences of suicidal ideations
Time frame: Study inclusion and at 9 months at study completion
Well-being
Time frame: Study inclusion and at 9 months at study completion
Change in quality of relation between patient and relatives
Time frame: Study inclusion and at 9 months at study completion
Ability to apply therapeutic tools learnt in therapy to everyday life situations.
Time frame: At study inclusion and 9 months later at study conclusion
Perceived burden by relatives
Time frame: Study inclusion and at 9 months at study completion
Satisfaction and acceptability of treatment
Time frame: At study conclusion
Patient Recorded Outcome Measures (PROM)
Time frame: Study inclusion and at 9 months at study completion. Measured in patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 36853245Leichsenring F, Heim N, Leweke F, Spitzer C, Steinert C, Kernberg OF. Borderline Personality Disorder: A Review. JAMA. 2023 Feb 28;329(8):670-679. doi: 10.1001/jama.2023.0589.
- Background: PubMed 29505387Hastrup LH, Kongerslev MT, Simonsen E. Low Vocational Outcome Among People Diagnosed With Borderline Personality Disorder During First Admission to Mental Health Services in Denmark: A Nationwide 9-Year Register-Based Study. J Pers Disord. 2019 Jun;33(3):326-340. doi: 10.1521/pedi_2018_32_344. Epub 2018 Mar 5.
- Background: PubMed 34111874Reinholt N, Hvenegaard M, Christensen AB, Eskildsen A, Hjorthoj C, Poulsen S, Arendt MB, Rosenberg NK, Gryesten JR, Aharoni RN, Alro AJ, Christensen CW, Arnfred SM. Transdiagnostic versus Diagnosis-Specific Group Cognitive Behavioral Therapy for Anxiety Disorders and Depression: A Randomized Controlled Trial. Psychother Psychosom. 2022;91(1):36-49. doi: 10.1159/000516380. Epub 2021 Jun 10.
- Background: PubMed 22581157McMain SF, Guimond T, Streiner DL, Cardish RJ, Links PS. Dialectical behavior therapy compared with general psychiatric management for borderline personality disorder: clinical outcomes and functioning over a 2-year follow-up. Am J Psychiatry. 2012 Jun;169(6):650-61. doi: 10.1176/appi.ajp.2012.11091416.
- BackgroundMuscroft J, Bowl R. The impact of depression on caregivers and other family members: Implications for professional support. http://dx.doi.org/101080/09515070050011105 2010; 13: 117-34.
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- Individual participant dataSharing planned: Yes. Available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carsten Hjorthøj, Ph.d. principal investigator
Copenhagen Research Center for Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The experimental intervention PEGASUS and Treatment as usual in people with Borderline Personality Disorder and Relatives, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ditte H. Rotvig, MD (+45 31154887, ditte.hoeyer.rotvig@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of functioning (time frame: Study inclusion and at 9 months at study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06563466, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.