Clinical trial NCT06563466: PEGASUS - Improving Treatment for Patients with Emotionally Unstable Personality Disorder
Official title: PEGASUS - Improving Treatment for Patients with Emotionally Unstable Personality Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Borderline Personality Disorder
Relatives
Keywords: Borderline Personality Disorder
Relatives
Group psychotherapy
Case management
Psychoeducation
Family
Caregiver
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Participating Patients

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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:

Inclusion Criteria:

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

Exclusion criteria: None

Primary outcomes:
measure: Level of functioning
timeFrame: Study inclusion and at 9 months at study completion
Secondary outcomes:
measure: Symptom relief
timeFrame: Study inclusion and at 9 months at study completion
measure: Presences of suicidal ideations
timeFrame: Study inclusion and at 9 months at study completion
measure: Well-being
timeFrame: Study inclusion and at 9 months at study completion
measure: Change in quality of relation between patient and relatives
timeFrame: Study inclusion and at 9 months at study completion
measure: Ability to apply therapeutic tools learnt in therapy to everyday life situations.
timeFrame: At study inclusion and 9 months later at study conclusion
measure: Perceived burden by relatives
timeFrame: Study inclusion and at 9 months at study completion
measure: Satisfaction and acceptability of treatment
timeFrame: At study conclusion
measure: Patient Recorded Outcome Measures (PROM)
timeFrame: Study inclusion and at 9 months at study completion. Measured in patients
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Research Center for Mental Health - CORE
Study officials:
affiliation: Copenhagen Research Center for Mental Health
name: Carsten Hjorthøj, Ph.d.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Linehan MM. Skills training manual for treating borderline personality disorder. New York: Guilford Press, 1993.
citation: Linehan M. DBT skills training manual, Second edition. New York: The Guilford Press, 2015.
citation: 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.
citation: 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.
citation: https://www.regioner.dk/media/5559/pakkeforloeb-for-emotionel-ustabil-personlighedsforstyrrelse.pdf