Comparing Mentalization-based Treatment And A Dialectical Behavior Therapy-inspired Treatment On The Utilization Of Services And The Dropout Rate In A Clinical Adult Population With A Cluster B Personality Disorder

October 6, 2021 updated by: Ciusss de L'Est de l'Île de Montréal

Comparaison d'Une thérapie basée Sur la Mentalisation et d'un Traitement inspiré de la thérapie Comportementale Dialectique Sur l'Utilisation Des Services et Sur le Taux d'Abandon Dans Une Population Clinique Adulte Atteinte d'un Trouble de la personnalité du Groupe B

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Visits To The Emergency Room
Time Frame: One year before the index date (first group therapy meeting) to one year after the index date.
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
Time Frame: One year before the index date (first group therapy meeting) to one year after the index date.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dropout rate
Time Frame: From the beginning until the end of the psychotherapy treatment.
The comparison of the dropout rate between mentalization-based treatment and dialectical behavior therapy.
From the beginning until the end of the psychotherapy treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Investigators

  • Principal Investigator: Simon Poirier, MD, Ciusss de L'Est de l'Île de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

August 4, 2021

Study Registration Dates

First Submitted

August 13, 2021

First Submitted That Met QC Criteria

August 13, 2021

First Posted (Actual)

August 20, 2021

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

October 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STRP1 2020-2193

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Borderline Personality Disorder

Clinical Trials on Mentalization-based Treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe