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Trial record 11 of 611 for:    Personality Disorders

Outcomes of Mentalization-Based Treatment for Borderline Personality Disorder

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ClinicalTrials.gov Identifier: NCT03295838
Recruitment Status : Completed
First Posted : September 28, 2017
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Viktor Kaldo, Karolinska Institutet

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).

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Behavioral: Mentalization-based treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Symptom, Alexithymia and Self-image Outcomes of Mentalization-Based Treatment for Borderline Personality Disorder: a Naturalistic Study
Actual Study Start Date : February 1, 2007
Actual Primary Completion Date : May 3, 2014
Actual Study Completion Date : May 3, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mentalization-based Treatment
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.
Behavioral: Mentalization-based treatment
See Arm description




Primary Outcome Measures :
  1. Borderline Symptoms [ Time Frame: 0-18 months ]
    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 :
  1. Suicidality [ Time Frame: 0-18 months ]
    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.

  2. General Psychiatric Symptoms [ Time Frame: 0-18 months ]
    General psychiatric symptoms were measured using the Symptom Checklist-90 Revised (SCL-90-R), an established instrument with well-known reliability and validity.

  3. Self-harm [ Time Frame: 0-18 months ]
    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).

  4. Alexithymia [ Time Frame: 0-18 months ]
    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.

  5. Self-image [ Time Frame: 0-18 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identification.
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295838


Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Viktor Kaldo, PhD Karolinska Institutet

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Viktor Kaldo, Med PhD, clinical psychologist, associate professor, research team leader, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03295838     History of Changes
Other Study ID Numbers: DNR 2011/1909-31/3
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The dataset used and/or analysed during the current study are available from the corresponding author on reasonable request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Analytic Code
Time Frame: 1st feb 2007 - 3rd may 2014.
Access Criteria: Upon reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Viktor Kaldo, Karolinska Institutet:
Borderline personality disorder
Psychotherapy
Treatment outcome
Pragmatic clinical trials as topic
Mentalization-based treatment
Alexithymia

Additional relevant MeSH terms:
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Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders