Clinical trial NCT06212024: MBT-early: a Single Case Experimental Design
Official title: The Effectiveness of Mentalization-Based Treatment-Early (MBT-early) in Adolescents With Emerging Borderline-personality Disorder: a Single Case Experimental Design
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Borderline Personality Disorder
Keywords: Borderline personality disorder
Early intervention
Single case experimental design
Treatment outcome
Lead sponsor: De Viersprong
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 6
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of this study consists of adolescents referred to de Viersprong, with early-stage BPD, that are indicated for MBT-early by means of regular intake procedure. All adolescents referred to MBT-early are eligible for participation in the study, as there are no additional inclusion criteria for the study, aside from the clinical inclusions and exclusion criteria for the MBT-Early intervention

Brief summary: Borderline personality disorder (BPD) is characterized by problems in emotion regulation, identity disturbances, and impaired interpersonal functioning. Because BPD may determine health and quality of life in long term, it is important to focus on early detection and early intervention to prevent worsening. In this study, the effectiveness of a new intervention, MBT-early, is investigated in adolescents with borderline personality problems through a single case experimental design (SCED). Existing studies into the efficacy of psychotherapeutic interventions for young people with a (subclinical) borderline personality disorder (BPD) show mixed results. An obvious explanation therefore lies in the heterogeneity of the samples studied, where the same intervention is investigated by young people with some characteristics of borderline personality problems in an early stage as by young people with significant borderline personality problems at a later stage. However, there is evidence that interventions should be targeted specifically at the stage of progression of the disorder ('staged care'). Interventions may be more effective when they correspond to the stage of disease progression. MBT-early is an intervention intended for young people in an early stage of BPD. The intervention not only addresses the characteristics of BPD, but generally aims to improve personality functioning. MBT-early focuses on strengthening the young person's mentalizing capacity and to increase epistemic trust (the openness to learn from others) in order to prevent developmental stagnation and chronic consequences of personality disfunctioning. Although there is evidence for the efficacy of MBT for adults and adolescents, MBT-early has not yet been studied in terms of effectiveness. This study sets out to investigate the effectiveness of MBT-early, using a Single Case Experimental Design. The investigators hypothesize that treating youngsters with early features of BPD with MBT-early results in reduction of features of personality problems and the most frequently occurring symptoms (depressive symptoms). Exploratively mechanisms of change are being explored.

Research questions:

1. What is the effectiveness of MBT-early in youth with early stage BPD? 1a) What effect does MBT-early have on the improvement of personality functioning? 1b) What effect does early MBT have on the degree of depressed mood?
2. What are the possible working mechanisms of MBT-early? 2a) Does the youth's mentalizing ability influence the improvement of personality functioning? 2b) Does epistemic trust affect the improvement of personality functioning?

Objective of the study: The primary objective is to study the effectiveness of MBT-early in terms of treatment outcome on personality functioning and depressive symptoms. As a second objective the investigators will exploratively study the presumed working mechanisms of the MBT-early intervention (mentalizing capacities and epistemic trust).


Eligibility criteria: Inclusion Criteria:

1. age between 12 and 18 years,
2. Three to six traits of borderline personality disorder as assessed by the Structured Clinical Interview for DSM-5 Syndrome Disorders
3. Mild to moderate disability with regard to functioning in school, at home and in the peer group.

Exclusion Criteria:

1. presence of a primary diagnosis that requires other specialist treatment (e.g. autism spectrum disorder, chronic psychotic disorder, severe eating disorder of sever substance abuse disorder),
2. More than one comorbid classification,
3. IQ \< 75,
4. Severe disability with regard to functioning in school, at home and in the peer group representative for later stage BPD.

Primary outcomes:
measure: Level of Personality Functioning
timeFrame: through study completion, approximately 1 year
measure: Depressive symptoms
timeFrame: through study completion, approximately 1 year
Secondary outcomes:
measure: Mentalizing Capacities
timeFrame: through study completion, approximately 1 year
measure: Epistemic Trust
timeFrame: through study completion, approximately 1 year
Other outcomes:
Locations:
city: Halsteren
country: Netherlands
facility: Psychotherapeutisch centrum de Viersprong, te Halsteren
Study officials:
affiliation: Psychotherapeutisch centrum de Viersprong, te Halsteren
name: Maaike L. Smits, PhD
role: PRINCIPAL_INVESTIGATOR
References: