PEGASUS - Improving Treatment for Patients With Emotionally Unstable Personality Disorder

NCT06563466 | Recruiting

• 2 other identifiers: PEGASUS EUPD3166-00026B
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Borderline Personality Disorder; Relatives

Keywords

Borderline Personality Disorder; Relatives; Group psychotherapy; Case management; Psychoeducation; Family; Caregiver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Symptom relief

  Study inclusion and at 9 months at study completion

• Presences of suicidal ideations

  Study inclusion and at 9 months at study completion

• Well-being

  Study inclusion and at 9 months at study completion

• Change in quality of relation between patient and relatives

  Study inclusion and at 9 months at study completion

• Ability to apply therapeutic tools learnt in therapy to everyday life situations.

  At study inclusion and 9 months later at study conclusion

Study Arms (2)

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.

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.

Other: The experimental intervention PEGASUS

Interventions

The experimental intervention PEGASUS OTHER

See arm description.

Also known as: Case Manager, Family-based interventions

The experimental intervention PEGASUS

Treatment as usual OTHER

See arm description

Treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Must be able to give an informed written consent.
• ≥18 years of age.
• Capable of reading and understanding Danish.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• Hvidovre University Hospital: collaborator

Study Sites (1)

Copenhagen Research Center for Mental Health - CORE

Copenhagen, 2900, Denmark

RECRUITING

Related Publications (22)

• 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.

  PMID: 36853245 BACKGROUND

• Hastrup 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.

  PMID: 29505387 BACKGROUND

• Reinholt 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.

  PMID: 34111874 BACKGROUND

• McMain 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.

  PMID: 22581157 BACKGROUND

• Muscroft 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.

  BACKGROUND

• 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.

  PMID: 21135638 BACKGROUND

• Lawn 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.

  PMID: 25857849 BACKGROUND

• Petersen 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.

  PMID: 16141449 BACKGROUND

• Correll 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.

  PMID: 29800949 BACKGROUND

• Puntis 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.

  PMID: 33135811 BACKGROUND

• Seigerman 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.

  PMID: 32704374 BACKGROUND

• Chanen 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.

  PMID: 34910093 BACKGROUND

• Bateman 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.

  PMID: 29999394 BACKGROUND

• Pearce 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.

  PMID: 28352470 BACKGROUND

• Grenyer 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.

  PMID: 29505385 BACKGROUND

• Flynn D, Kells M, Joyce M, Corcoran P, Herley S, Suarez C, Cotter P, Hurley J, Weihrauch M, Groeger J. Family Connections versus optimised treatment-as-usual for family members of individuals with borderline personality disorder: non-randomised controlled study. Borderline Personal Disord Emot Dysregul. 2017 Aug 30;4:18. doi: 10.1186/s40479-017-0069-1. eCollection 2017.

  PMID: 28861273 BACKGROUND

• Bohus M, Kleindienst N, Limberger MF, Stieglitz RD, Domsalla M, Chapman AL, Steil R, Philipsen A, Wolf M. The short version of the Borderline Symptom List (BSL-23): development and initial data on psychometric properties. Psychopathology. 2009;42(1):32-9. doi: 10.1159/000173701. Epub 2008 Nov 20.

  PMID: 19023232 BACKGROUND

• Linehan MM. Skills training manual for treating borderline personality disorder. New York: Guilford Press, 1993.

  BACKGROUND

• Linehan M. DBT skills training manual, Second edition. New York: The Guilford Press, 2015.

  BACKGROUND

• McFarlane WR, Lukens E, Link B, Dushay R, Deakins SA, Newmark M, Dunne EJ, Horen B, Toran J. Multiple-family groups and psychoeducation in the treatment of schizophrenia. Arch Gen Psychiatry. 1995 Aug;52(8):679-87. doi: 10.1001/archpsyc.1995.03950200069016.

  PMID: 7632121 BACKGROUND

• Hansen NH, Juul L, Pallesen KJ, Fjorback LO. Effect of a Compassion Cultivation Training Program for Caregivers of People With Mental Illness in Denmark: A Randomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e211020. doi: 10.1001/jamanetworkopen.2021.1020.

  PMID: 33683334 BACKGROUND

• https://www.regioner.dk/media/5559/pakkeforloeb-for-emotionel-ustabil-personlighedsforstyrrelse.pdf

  BACKGROUND

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Case Managers; Therapeutics

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Carsten Hjorthøj, Ph.d.

  Copenhagen Research Center for Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ditte H. Rotvig, MD

CONTACT

+45 31154887; ditte.hoeyer.rotvig@regionh.dk

Carsten Hjorthøj, Ph.d.

CONTACT

+45 26136290; carsten.hjorthoej@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators, outcome assessor and statistician will be blinded. Because of the nature of this study, it will not be possible to blind the participant or therapists providing the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 20, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): August 31, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After publication
• Access Criteria: Upon request

Locations

DK (1)