NCT03295838

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2007

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2014

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

7.3 years

First QC Date

September 14, 2017

Last Update Submit

September 25, 2017

Conditions

Keywords

Borderline personality disorderPsychotherapyTreatment outcomePragmatic clinical trials as topicMentalization-based treatmentAlexithymia

Outcome Measures

Primary Outcomes (1)

  • 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").

    0-18 months

Secondary Outcomes (5)

  • Suicidality

    0-18 months

  • General Psychiatric Symptoms

    0-18 months

  • Self-harm

    0-18 months

  • Alexithymia

    0-18 months

  • Self-image

    0-18 months

Study Arms (1)

Mentalization-based Treatment

EXPERIMENTAL

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

Interventions

See Arm description

Mentalization-based Treatment

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSelf-identification.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Borderline Personality DisorderAffective Symptoms

Interventions

Mentalization-Based Therapy

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Viktor Kaldo, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Med PhD, clinical psychologist, associate professor, research team leader

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 28, 2017

Study Start

February 1, 2007

Primary Completion

May 3, 2014

Study Completion

May 3, 2014

Last Updated

September 28, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

The dataset used and/or analysed during the current study are available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
1st feb 2007 - 3rd may 2014.
Access Criteria
Upon reasonable request.