An interventional study of Mentalization-based treatment in Borderline Personality Disorder, sponsored by Karolinska Institutet. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-28.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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).
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.
278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.
This study's enrollment of 75 is close to the median of 70 across 221 interventional studies indexed under Borderline Personality Disorder.
Browse Borderline Personality Disorder studies →Karolinska Institutet is the lead sponsor of 1,149 studies on the registry; 277 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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").
Time frame: 0-18 months
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.
Time frame: 0-18 months
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.
Time frame: 0-18 months
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).
Time frame: 0-18 months
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.
Time frame: 0-18 months
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.
Time frame: 0-18 months
No study locations are listed for this record.
Plan to share: Yes — The dataset used and/or analysed during the current study are available from the corresponding author on reasonable request.
Supporting information: Study protocol, Informed consent form, Analytic code
Time frame: 1st feb 2007 - 3rd may 2014.
Access criteria: Upon reasonable request.
Ran from Feb 2007 to primary completion in May 2014, 87 months.
Of 105 non-industry interventional studies with no phase under Borderline Personality Disorder, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 54. This study's 87 months is above that.
Counting every sponsor, half of 107 studies reached it within 35 months; a quarter within 24 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Borderline Personality Disorder →