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Outcomes of Mentalization-Based Treatment for Borderline Personality Disorder

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mentalization-based treatment
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Borderline personality disorder, Psychotherapy, Treatment outcome, Pragmatic clinical trials as topic, Mentalization-based treatment, Alexithymia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • To be included, BPD diagnosis was confirmed by SCID-II interview and the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview, together with a consensus discussion between MBT therapists using DSM-IV and ICD-10 criteria. All patients referred between 2007-02-01 and 2012-05-30 were eligible for inclusion.

Exclusion Criteria:

  • Exclusion criteria were: IQ<85, psychotic disorder other than schizotypal personality disorder, acute/temporary psychosis, previously diagnosed autism-spectrum disorder, bipolar disorder type I and severe eating or substance use disorder.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Mentalization-based Treatment

    Arm Description

    MBT was conducted according to the treatment manual developed by Bateman & Fonagy. Patients were offered individual sessions with a psychotherapist and group sessions with 6-8 participants and 1-2 group therapists for 18 months. An introductory psycho-educational component (9-12 sessions) was also offered focusing on explicit mentalising skills (i.e. understanding one's own or others' intentions). Group and individual MBT focused on implicit mentalising towards self and others.

    Outcomes

    Primary Outcome Measures

    Borderline Symptoms
    Key psychiatric and borderline symptomatology as measured by the Karolinska Borderline And Symptoms Scales (KABOSS-S) was the primary outcome measure. The KABOSS-S consists of three general symptom scales (depression, anxiety, obsessive-compulsive symptoms) derived from the Comprehensive Psychopathological Self-rating Scale for Affective Syndromes and one specific borderline scale compromising the items "Mood swings", "Ability to understand own emotions", "Self-control", "Self-soothing", "Feelings of abandonment", "Feelings of emptiness", "Self-image" and "Reality Presence". Each item is scored on a Likert scale from 0 ("no presence") to 6 ("severe").

    Secondary Outcome Measures

    Suicidality
    Suicidality was measured by the Suicide Assessment Scale, Self-Report (SUAS-S), which covers factors known to influence suicide risk, such as affect, bodily states, control and coping, emotional reactivity, as well as suicidal thoughts and behaviour.
    General Psychiatric Symptoms
    General psychiatric symptoms were measured using the Symptom Checklist-90 Revised (SCL-90-R), an established instrument with well-known reliability and validity.
    Self-harm
    Self-harm was measured by the Deliberate Self-Harm Inventory-9 (DSHI-9), which has well-known reliability and validity. This measure was introduced halfway through the study period (N=42).
    Alexithymia
    The Toronto Alexithymia Scale-20 (TAS-20) was used to measure alexithymia. It comprises 20 items divided into three subscales: Difficulty Identifying Feelings, Difficulty Expressing Feelings and Externally Oriented Thinking. TAS-20 was used to measure affective mentalization.
    Self-image
    Self-image was assessed using Structural Analysis of Social Behavior (SASB). SASB is based on a circumplex model, measuring self-image and interpersonal interactions in relation to three interpersonal "surfaces" (i.e. actions of others, reactions to others and the introject, or what can be called the self-image. The third surface (self-image) was used, which comprises eight clusters of self-image: 1) Autonomy; 2) Self-affirmation; 3) Active self-love; 4) Self-protection; 5) Self-control; 6) Self-blame; 7) Self-attack; and 8) Self-neglect.

    Full Information

    First Posted
    September 14, 2017
    Last Updated
    September 25, 2017
    Sponsor
    Karolinska Institutet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03295838
    Brief Title
    Outcomes of Mentalization-Based Treatment for Borderline Personality Disorder
    Official Title
    Symptom, Alexithymia and Self-image Outcomes of Mentalization-Based Treatment for Borderline Personality Disorder: a Naturalistic Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2007 (Actual)
    Primary Completion Date
    May 3, 2014 (Actual)
    Study Completion Date
    May 3, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska Institutet

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The effects of a psychological treatment, Mentalization-Based Treatment, was studied using a research protocol with patients with mood swings and impulsive behavior (borderline personality disorder).
    Detailed Description
    Background: Mentalization-based treatment (MBT) in borderline personality disorder (BPD) has a growing evidence base, but there is a lack of effectiveness and moderator studies. The present study examined the effectiveness of MBT in a naturalistic setting and explored psychiatric and psychological moderators of outcome. Method: Borderline and general psychiatric symptoms, suicidality, self-harm, alexithymia and self-image were measured in a group of BPD patients (n=75) receiving MBT; assessments were made at baseline, and subsequently after 6, 12 and 18 months (when treatment ended). Borderline symptoms were the primary outcome variable.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Borderline Personality Disorder
    Keywords
    Borderline personality disorder, Psychotherapy, Treatment outcome, Pragmatic clinical trials as topic, Mentalization-based treatment, Alexithymia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Patients were selected using a research protocol with defined criteria, all patients that were intended to treat in the Mentalization-based Treatment program were followed over 18 months and assessed for primary and secondary outcomes.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mentalization-based Treatment
    Arm Type
    Experimental
    Arm Description
    MBT was conducted according to the treatment manual developed by Bateman & Fonagy. Patients were offered individual sessions with a psychotherapist and group sessions with 6-8 participants and 1-2 group therapists for 18 months. An introductory psycho-educational component (9-12 sessions) was also offered focusing on explicit mentalising skills (i.e. understanding one's own or others' intentions). Group and individual MBT focused on implicit mentalising towards self and others.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mentalization-based treatment
    Intervention Description
    See Arm description
    Primary Outcome Measure Information:
    Title
    Borderline Symptoms
    Description
    Key psychiatric and borderline symptomatology as measured by the Karolinska Borderline And Symptoms Scales (KABOSS-S) was the primary outcome measure. The KABOSS-S consists of three general symptom scales (depression, anxiety, obsessive-compulsive symptoms) derived from the Comprehensive Psychopathological Self-rating Scale for Affective Syndromes and one specific borderline scale compromising the items "Mood swings", "Ability to understand own emotions", "Self-control", "Self-soothing", "Feelings of abandonment", "Feelings of emptiness", "Self-image" and "Reality Presence". Each item is scored on a Likert scale from 0 ("no presence") to 6 ("severe").
    Time Frame
    0-18 months
    Secondary Outcome Measure Information:
    Title
    Suicidality
    Description
    Suicidality was measured by the Suicide Assessment Scale, Self-Report (SUAS-S), which covers factors known to influence suicide risk, such as affect, bodily states, control and coping, emotional reactivity, as well as suicidal thoughts and behaviour.
    Time Frame
    0-18 months
    Title
    General Psychiatric Symptoms
    Description
    General psychiatric symptoms were measured using the Symptom Checklist-90 Revised (SCL-90-R), an established instrument with well-known reliability and validity.
    Time Frame
    0-18 months
    Title
    Self-harm
    Description
    Self-harm was measured by the Deliberate Self-Harm Inventory-9 (DSHI-9), which has well-known reliability and validity. This measure was introduced halfway through the study period (N=42).
    Time Frame
    0-18 months
    Title
    Alexithymia
    Description
    The Toronto Alexithymia Scale-20 (TAS-20) was used to measure alexithymia. It comprises 20 items divided into three subscales: Difficulty Identifying Feelings, Difficulty Expressing Feelings and Externally Oriented Thinking. TAS-20 was used to measure affective mentalization.
    Time Frame
    0-18 months
    Title
    Self-image
    Description
    Self-image was assessed using Structural Analysis of Social Behavior (SASB). SASB is based on a circumplex model, measuring self-image and interpersonal interactions in relation to three interpersonal "surfaces" (i.e. actions of others, reactions to others and the introject, or what can be called the self-image. The third surface (self-image) was used, which comprises eight clusters of self-image: 1) Autonomy; 2) Self-affirmation; 3) Active self-love; 4) Self-protection; 5) Self-control; 6) Self-blame; 7) Self-attack; and 8) Self-neglect.
    Time Frame
    0-18 months

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    Self-identification.
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To be included, BPD diagnosis was confirmed by SCID-II interview and the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview, together with a consensus discussion between MBT therapists using DSM-IV and ICD-10 criteria. All patients referred between 2007-02-01 and 2012-05-30 were eligible for inclusion. Exclusion Criteria: Exclusion criteria were: IQ<85, psychotic disorder other than schizotypal personality disorder, acute/temporary psychosis, previously diagnosed autism-spectrum disorder, bipolar disorder type I and severe eating or substance use disorder.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Viktor Kaldo, PhD
    Organizational Affiliation
    Karolinska Institutet
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The dataset used and/or analysed during the current study are available from the corresponding author on reasonable request.
    IPD Sharing Time Frame
    1st feb 2007 - 3rd may 2014.
    IPD Sharing Access Criteria
    Upon reasonable request.
    Citations:
    PubMed Identifier
    29890960
    Citation
    Lof J, Clinton D, Kaldo V, Ryden G. Symptom, alexithymia and self-image outcomes of Mentalisation-based treatment for borderline personality disorder: a naturalistic study. BMC Psychiatry. 2018 Jun 11;18(1):185. doi: 10.1186/s12888-018-1699-6.
    Results Reference
    derived

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    Outcomes of Mentalization-Based Treatment for Borderline Personality Disorder

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