NCT05014217

Brief Summary

Cluster B personality disorders (borderline, narcissistic, antisocial and/or histrionic) are an important clinical consideration because of their high prevalence and associated morbidity. Although many studies examine borderline personality disorder, few of them explore cluster B personality disorders as a whole. In clinical practice, personality disorders are frequently comorbid. Patients who receive services in specialized clinics for these disorders often have a complex diagnosis that include many cluster B personality disorders. Therefore, our study globally examines patients with cluster B personality disorders even though borderline personality disorder is empirically the most studied psychopathology. Previous data suggests that borderline personality disorder has a prevalence of 2% in the general population, of 25% in the clinical psychiatric population and of 15% in all visits to the emergency room. Furthermore, it is associated with social costs estimated from 15,000$ to 50,000$ USD per patient per year. In Quebec, this psychopathology is associated with an increased mortality rate compared to the general population, totaling a loss of nine years for women and 13 years for men of life expectancy. Other studies suggest that borderline personality disorder is often comorbid with other personality disorders, including those in cluster B. The population with comorbid personality disorders have a worse prognosis and a lower chance of reaching symptomatic remission, which is the reason why it is crucial to better understand and study patients with cluster B personality disorders. The study compares the effectiveness of two psychotherapies for borderline personality disorder, mentalization-based therapy and a modified version of Linehan's dialectical behavior therapy, in a retrospective naturalistic study of patients with at least one cluster B personality disorder who have undergone either treatment. The scarcity of data on cluster B personality disorders and on the comparison between MBT and DBT further highlights the necessity of a naturalistic study like ours to examine both aspects and bring research closer to the clinical setting. Based on clinical observations, the investigators believe that there will be no statistically significant difference between either treatment.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
403

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
Last Updated

October 13, 2021

Status Verified

August 1, 2021

Enrollment Period

5 years

First QC Date

August 13, 2021

Last Update Submit

October 6, 2021

Conditions

Keywords

cluster B personality disordermentalization-based treatmentdialectical behavior therapyborderline personality disorderservice utilizationdropout ratenaturalistic study

Outcome Measures

Primary Outcomes (2)

  • Number of Visits To The Emergency Room

    A comparison of the difference between a patient's number of visits to the emergency room in the year prior to and the year following the index date for each treatment.

    One year before the index date (first group therapy meeting) to one year after the index date.

  • Number of Hospitalizations

    A comparison of the difference between a patient's number of hospitalizations in the year prior to and the year following the index date for each treatment.

    One year before the index date (first group therapy meeting) to one year after the index date.

Secondary Outcomes (1)

  • Dropout rate

    From the beginning until the end of the psychotherapy treatment.

Study Arms (2)

Mentalization-based Treatment

Participants who have been oriented to the mentalization-based treatment among the clinical adult population with a cluster B personality disorder.

Behavioral: Mentalization-based Treatment

Dialectical Behavior Therapy-inspired Treatment

Participants who have been oriented to the dialectical behavior therapy-inspired treatment among the clinical adult population with a cluster B personality disorder.

Behavioral: Dialectical Behavior Therapy-inspired Treatment

Interventions

An empirically-validated intervention for personality disorders based on the attachment theory and on knowledge from developmental psychology and cognitive neuroscience (Bateman and Fonagy, 2004). Patients assist psychoeducative group meetings beforehand, along with a pretreatment of four to six individual meetings (over four to eight weeks), followed by bi-weekly individual follow-ups and weekly group follow-ups. The treatment lasts two years. Patients have an assessment meeting with their individual therapist and one of the group therapists at the end of each session. Psychiatric follow-up appointments are on an as-needed basis and every patient has a treatment contract with specific and measurable treatment objectives.

Mentalization-based Treatment

A psychotherapy developed by M. Linehan for patients with borderline personality disorder that combines cognitive behavioral therapy techniques (emotional regulation, practical exercises) with Buddhist meditation principles (stress tolerance, acceptance, open-mindedness) (Linehan, M. M. \& Dimeff, L., 2001). As opposed to Linehan's model, individual meetings are bi-weekly, no emergency phone service is offered, the mindful meditation module is reorganized into life habits modules, and every module includes mindfulness exercises. Patients assist psychoeducative group meetings beforehand, along with a pre-treatment of 4-6 individual meetings (over 4-8 weeks), followed by bi-weekly individual follow-ups and weekly group follow-ups. The treatment lasts one year, but can be extended to two years for eligible patients who are interested. Psychiatric follow-up appointments are on an as-needed basis. Every every patient has a treatment contract with specific and measurable treatment objectives.

Dialectical Behavior Therapy-inspired Treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with at least one cluster B personality disorder and admitted to the Service of personality and relational disorders at the Institut universitaire de Santé Mentale de Montréal after being referred to the program and oriented to mentalization-based treatment or dialectical behavior therapy. Patients with comorbid personality disorders are also included to better represent clinical practice.

You may qualify if:

  • Meet the general criteria for a personality disorder
  • Be diagnosed with at least one cluster B personality disorder
  • Be admitted to the Service of personality and relational disorders and referred to mentalization-based treatment or a treatment inspired from dialectical behavior therapy

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (24)

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    PMID: 17560953BACKGROUND
  • Barnicot K, Crawford M. Dialectical behaviour therapy v. mentalisation-based therapy for borderline personality disorder. Psychol Med. 2019 Sep;49(12):2060-2068. doi: 10.1017/S0033291718002878. Epub 2018 Oct 10.

    PMID: 30303061BACKGROUND
  • Bateman, A. & Fonagy, P. (2004). Psychotherapy of Borderline Personality Disorder:mentalisation-based treatment. Oxford, UK: Oxford University Press.

    BACKGROUND
  • Bender DS, Dolan RT, Skodol AE, Sanislow CA, Dyck IR, McGlashan TH, Shea MT, Zanarini MC, Oldham JM, Gunderson JG. Treatment utilization by patients with personality disorders. Am J Psychiatry. 2001 Feb;158(2):295-302. doi: 10.1176/appi.ajp.158.2.295.

    PMID: 11156814BACKGROUND
  • Cailhol, L., et al. (2015). Surveillance des troubles de la personnalité au Québec : prévalence, mortalité et profil d'utilisation des services, INSPQ (Institut National de santé publique du Québec).

    BACKGROUND
  • Cristea IA, Gentili C, Cotet CD, Palomba D, Barbui C, Cuijpers P. Efficacy of Psychotherapies for Borderline Personality Disorder: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2017 Apr 1;74(4):319-328. doi: 10.1001/jamapsychiatry.2016.4287.

    PMID: 28249086BACKGROUND
  • Duggan, C., Huband, N., Smailagic, N., Ferriter, M., & Adams, C. (2007). The use of psychological treatments for people with personality disorder: A systematic review of randomized controlled trials. Personality and Mental Health, 1, 95-125.

    BACKGROUND
  • Linehan, M. M. & Dimeff, L. (2001). Dialectical Behavior Therapy in a nutshell [archive], The California Psychologist, 34, 10-13.

    BACKGROUND
  • Linehan MM, Comtois KA, Murray AM, Brown MZ, Gallop RJ, Heard HL, Korslund KE, Tutek DA, Reynolds SK, Lindenboim N. Two-year randomized controlled trial and follow-up of dialectical behavior therapy vs therapy by experts for suicidal behaviors and borderline personality disorder. Arch Gen Psychiatry. 2006 Jul;63(7):757-66. doi: 10.1001/archpsyc.63.7.757.

    PMID: 16818865BACKGROUND
  • Links PS, Heslegrave R, van Reekum R. Prospective follow-up study of borderline personality disorder: prognosis, prediction of outcome, and Axis II comorbidity. Can J Psychiatry. 1998 Apr;43(3):265-70. doi: 10.1177/070674379804300305.

    PMID: 9561315BACKGROUND
  • Luyten P, Leichsenring F, Abbass A, Hilsenroth M, Rabung S, Steinert C. What to conclude from a non-randomized clinical trial comparing dialectical behavior therapy and mentalization-based treatment in patients with borderline personality disorder? Psychol Med. 2019 Dec;49(16):2810-2811. doi: 10.1017/S0033291719001922. Epub 2019 Sep 19. No abstract available.

    PMID: 31535604BACKGROUND
  • McGlashan TH, Grilo CM, Skodol AE, Gunderson JG, Shea MT, Morey LC, Zanarini MC, Stout RL. The Collaborative Longitudinal Personality Disorders Study: baseline Axis I/II and II/II diagnostic co-occurrence. Acta Psychiatr Scand. 2000 Oct;102(4):256-64. doi: 10.1034/j.1600-0447.2000.102004256.x.

    PMID: 11089725BACKGROUND
  • McMurran M, Huband N, Overton E. Non-completion of personality disorder treatments: a systematic review of correlates, consequences, and interventions. Clin Psychol Rev. 2010 Apr;30(3):277-87. doi: 10.1016/j.cpr.2009.12.002. Epub 2009 Dec 13.

    PMID: 20047783BACKGROUND
  • Meuldijk D, McCarthy A, Bourke ME, Grenyer BF. The value of psychological treatment for borderline personality disorder: Systematic review and cost offset analysis of economic evaluations. PLoS One. 2017 Mar 1;12(3):e0171592. doi: 10.1371/journal.pone.0171592. eCollection 2017.

    PMID: 28249032BACKGROUND
  • Moran P, Rendu A, Jenkins R, Tylee A, Mann A. The impact of personality disorder in UK primary care: a 1-year follow-up of attenders. Psychol Med. 2001 Nov;31(8):1447-54. doi: 10.1017/s003329170105450z.

    PMID: 11722159BACKGROUND
  • Karterud S, Pedersen G, Bjordal E, Brabrand J, Friis S, Haaseth O, Haavaldsen G, Irion T, Leirvag H, Torum E, Urnes O. Day treatment of patients with personality disorders: experiences from a Norwegian treatment research network. J Pers Disord. 2003 Jun;17(3):243-62. doi: 10.1521/pedi.17.3.243.22151.

    PMID: 12839103BACKGROUND
  • Rohde C, Polcwiartek C, Correll CU, Nielsen J. Real-World Effectiveness of Clozapine for Borderline Personality Disorder: Results From a 2-Year Mirror-Image Study. J Pers Disord. 2018 Dec;32(6):823-837. doi: 10.1521/pedi_2017_31_328. Epub 2017 Nov 9.

    PMID: 29120277BACKGROUND
  • Sansone RA, Farukhi S, Wiederman MW. Utilization of primary care physicians in borderline personality. Gen Hosp Psychiatry. 2011 Jul-Aug;33(4):343-6. doi: 10.1016/j.genhosppsych.2011.04.006. Epub 2011 May 20.

    PMID: 21762830BACKGROUND
  • Soeteman DI, Hakkaart-van Roijen L, Verheul R, Busschbach JJ. The economic burden of personality disorders in mental health care. J Clin Psychiatry. 2008 Feb;69(2):259-65. doi: 10.4088/jcp.v69n0212.

    PMID: 18363454BACKGROUND
  • Stoffers JM, Vollm BA, Rucker G, Timmer A, Huband N, Lieb K. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD005652. doi: 10.1002/14651858.CD005652.pub2.

    PMID: 22895952BACKGROUND
  • Torgersen S, Kringlen E, Cramer V. The prevalence of personality disorders in a community sample. Arch Gen Psychiatry. 2001 Jun;58(6):590-6. doi: 10.1001/archpsyc.58.6.590.

    PMID: 11386989BACKGROUND
  • Webb, D., & McMurran, M. (2009). A comparison of women who continue and discontinue treatment for borderline personality disorder. Personality and Mental Health, 3, 142-149.

    BACKGROUND
  • Zanarini MC, Frankenburg FR, Dubo ED, Sickel AE, Trikha A, Levin A, Reynolds V. Axis II comorbidity of borderline personality disorder. Compr Psychiatry. 1998 Sep-Oct;39(5):296-302. doi: 10.1016/s0010-440x(98)90038-4.

    PMID: 9777282BACKGROUND
  • Zimmerman M, Chelminski I, Young D. The frequency of personality disorders in psychiatric patients. Psychiatr Clin North Am. 2008 Sep;31(3):405-20, vi. doi: 10.1016/j.psc.2008.03.015.

    PMID: 18638643BACKGROUND

MeSH Terms

Conditions

DiseaseBorderline Personality Disorder

Interventions

Mentalization-Based Therapy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPersonality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Simon Poirier, MD

    Ciusss de L'Est de l'Île de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2021

First Posted

August 20, 2021

Study Start

January 1, 2015

Primary Completion

December 31, 2019

Study Completion

August 4, 2021

Last Updated

October 13, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Patients have not consented to have their data be available to researchers outside the institution.