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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05014217
Other study ID # STRP1 2020-2193
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date August 4, 2021

Study information

Verified date August 2021
Source Ciusss de L'Est de l'Île de Montréal
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 403
Est. completion date August 4, 2021
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - None

Study Design


Intervention

Behavioral:
Mentalization-based Treatment
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.
Dialectical Behavior Therapy-inspired 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ciusss de L'Est de l'Île de Montréal

References & Publications (24)

Ansell EB, Sanislow CA, McGlashan TH, Grilo CM. Psychosocial impairment and treatment utilization by patients with borderline personality disorder, other personality disorders, mood and anxiety disorders, and a healthy comparison group. Compr Psychiatry. 2007 Jul-Aug;48(4):329-36. Epub 2007 Apr 6. — View Citation

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. — View Citation

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

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. — View Citation

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).

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. Review. — View Citation

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.

Karterud S, Pedersen G, Bjordal E, Brabrand J, Friis S, Haaseth O, Haavaldsen G, Irion T, Leirvåg H, Tørum 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. — View Citation

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. Erratum in: Arch Gen Psychiatry. 2007 Dec;64(12):1401. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Stoffers JM, Völlm BA, Rücker G, Timmer A, Huband N, Lieb K. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD005652. doi: 10.1002/14651858.CD005652.pub2. Review. — View Citation

Torgersen S, Kringlen E, Cramer V. The prevalence of personality disorders in a community sample. Arch Gen Psychiatry. 2001 Jun;58(6):590-6. — View Citation

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.

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. — View Citation

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. Review. — View Citation

* Note: There are 24 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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 Dropout rate The comparison of the dropout rate between mentalization-based treatment and dialectical behavior therapy. From the beginning until the end of the psychotherapy treatment.
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